Date: 2023-08-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Delegated Regulation (EU) 2023/1605 of 22 May 2023 supplementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council as regards the determination of end points in the manufacturing chain of certain organic fertilisers and soil improvers (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Regulation supplements Regulation (EC) No 1069/2009 by determining end points in the manufacturing chain for certain organic fertilisers and soil improvers. These derived products, manufactured in the Union, are no longer subject to Regulation (EC) No 1069/2009 once the end point is reached, provided they are used as component materials in EU fertilising products under Regulation (EU) 2019/1009. This Regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
End Points Defined:
* The Regulation defines "end points" as stages in the manufacturing chain beyond which derived products are no longer subject to Regulation (EC) No 1069/2009.
Scope:
* Applies to organic fertilisers and soil improvers manufactured in the Union.
* Concerns derived products used as component materials in EU fertilising products according to Regulation (EU) 2019/1009.
End Points for Specific Derived Products:
* The following derived products, manufactured in approved fertiliser plants, are considered to have reached their end point:
* Ash from Category 2 and 3 materials meeting Annex III requirements of Regulation (EU) No 142/2011.
* Residues from biogas plant transformation of animal by-products, fulfilling specific requirements in Annex V to Regulation (EU) No 142/2011.
* Compost meeting specific requirements in Annex V to Regulation (EU) No 142/2011.
* Processed manure and processed frass fulfilling specific requirements in Annex XI to Regulation (EU) No 142/2011.
Conditional End Points with Risk Mitigation:
* Certain derived products reach their end point only with risk mitigation measures and if their volume in the EU fertilising product is not more than 5%:
* Glycerine of Category 2 and 3 materials and other Category 2 material from biodiesel/renewable fuel production (fulfilling Annex IV requirements of Regulation (EU) No 142/2011).
* Category 3 materials other than glycerine (fulfilling Annex IV requirements of Regulation (EU) No 142/2011).
* Processed animal protein of Category 3 materials (fulfilling Annex X requirements of Regulation (EU) No 142/2011).
* Meat-and-bone meal of Category 2 materials processed with standard method 1 and marked with GTH (fulfilling Annexes IV & VIII requirements of Regulation (EU) No 142/2011).
* Blood products of Category 3 materials (fulfilling Annex X requirements of Regulation (EU) No 142/2011).
* Hydrolysed protein (fulfilling Annex X requirements of Regulation (EU) No 142/2011).
* Dicalcium phosphate and tricalcium phosphate (fulfilling Annex X requirements of Regulation (EU) No 142/2011).
* Horns, horn products, hooves and hoof products (fulfilling Annex XIII requirements of Regulation (EU) No 142/2011).
* If the derived products referred to above are present in the EU fertilising product in more than 5% by volume, they must be packed for end-user sale, labelled according to Regulation (EU) 2019/1009, and meet specific packaging and composition conditions: packages weigh no more than 50 kg or no more than 1000 kg with at least 10% volume of lime, mineral fertilisers or products referred to in Article 3.
Manufacturing Plant Approval:
* All listed derived products must be manufactured in a fertiliser plant approved under Article 24(1)(f) of Regulation (EC) No 1069/2009.
Impact Analysis:
Fertiliser Manufacturers:
* Impact: Need to ensure that the organic fertilisers and soil improvers they produce meet the end-point criteria specified in the regulation to comply with Regulation (EU) 2019/1009, and those manufacturing the products must be approved under Article 24(1)(f) of Regulation (EC) No 1069/2009.
* Action Required: Review manufacturing processes, ensure compliance with Annexes of Regulation (EU) No 142/2011, obtain necessary approvals, and adjust labelling and packaging as needed.
EU Commission:
* Impact: Responsible for the oversight and enforcement of the regulation to ensure the safety of the food and feed chain and to facilitate the market availability of EU fertilising products.
* Action Required: Monitor the implementation of the regulation across member states and address any issues that arise.
Member States:
* Impact: Must ensure that the regulation is correctly applied and enforced within their jurisdiction, including the approval and oversight of fertiliser plants.
* Action Required: Update national regulations as necessary and ensure that relevant authorities are aware of the new requirements.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the day-to-day business of the EU.
Regulation (EC) No 1069/2009: A European Parliament and Council regulation laying down health rules as regards animal by-products and derived products not intended for human consumption.
Regulation (EU) 2019/1009: A European Parliament and Council regulation laying down rules on the making available on the market of EU fertilising products.
Regulation (EU) No 142/2011: A Commission Regulation implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products.
European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Ursula VON DER LEYEN: The President of the European Commission.
Brussels: The de facto capital city of the European Union, located in Belgium.
8.8.2023 EN Official Journal of the European Union L 198/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION DELEGATED REGULATION (EU) 2023/1605
of 22 May 2023
supplementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council as
regards the determination of end points in the manufacturing chain of certain organic fertilisers and
soil improvers
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009laying
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)(1), and in particular Article 5(2), third subparagraph,
thereof,
Whereas:
(1) Regulation (EC) No 1069/2009 lays down public and animal health rules for derived products, in order to prevent
and minimise risks to public and animal health arising from those products, and in particular to protect the safety
of the food and feed chain. More specifically, it lays down rules as regards the safe treatment, and the processing or
transformation of animal by-products into derived products, including rules for the placing on the market and use
of organic fertilisers and soil improvers. In addition, Regulation (EC) No 1069/2009, as amended by Regulation
(EU) 2019/1009 of the European Parliament and of the Council(2), provides that the Commission is empowered to
adopt delegated acts to determine end points in the manufacturing chain, beyond which certain derived products are
no longer subject to the requirements of Regulation (EC) No 1069/2009.
(2) Regulation (EU) 2019/1009 establishes rules for the making available on the market of EU fertilising products. That
Regulation does not apply to derived products which are subject to the requirements of Regulation (EC)
No 1069/2009 when made available on the market. Pursuant to Regulation (EU) 2019/1009, certain derived
products may become, or be part of, an EU fertilising product provided that an end point in the manufacturing
chain of the derived product is reached, thereby ensuring animal and public health safety. Those derived products,
which have reached an end point in the manufacturing chain of certain organic fertilisers and soil improvers, will
no longer be subject to the requirements of Regulation (EC) No 1069/2009 and will fall only within the scope of
Regulation (EU) 2019/1009.
(1) OJ L 300, 14.11.2009, p. 1.
(2) 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).L 198/2 EN Official Journal of the European Union 8.8.2023
(3) On 2 December 2021, the European Food Safety Authority (EFSA) published a Scientific Opinion ‘Inactivation of
indicator microorganisms and biological hazards by standard and/or alternative processing methods in Category 2
and 3 animal by-products and derived products to be used as organic fertilisers and/or soil improvers’(3) (EFSA
Scientific Opinion of 2 December 2021). According to that Scientific Opinion, ash of Category 2 and 3 materials
which fulfils the requirements set out in Annex III to Commission Regulation (EU) No 142/2011(4), glycerine of
Category 2 and 3 materials, and other Category 2 materials derived from the production of biodiesel in accordance
with alternative methods for the production of biodiesels or renewable fuels set out in Annex IV to that Regulation,
represent a low risk for public and animal health due to safe processing. An end point in the manufacturing chain of
those derived products can be determined. Those derived products should reach the end point if they are used as
component material in accordance with Regulation (EU) 2019/1009.
(4) Certain derived products are not included in the EFSA Scientific Opinion of 2 December 2021since they have been
recently assessed by other EFSA Scientific Opinions. Compost and biogas digestion residues subject to the standard
transformation parameters were assessed in 2015 as safe in the EFSA Scientific Opinion of 13 November 2015
‘Risk to public and/or animal health of the treatment of dead-in-shell chicks (Category 2 material) to be used as raw
material for the production of biogas or compost with Category 3 approved method’(5). An EFSA Scientific Opinion
on the revision of the quantitative risk assessment (QRA) of the BSE risk posed by processed animal proteins
(PAP)(6) was adopted on 17 July 2018 for the purpose of the partial revision of the feed ban laid down in
Regulation (EC) No 999/2001 of the European Parliament and of the Council(7). Processed manure was assessed by
the EFSA Scientific Opinion of 27 April 2021‘Ability of different matrices to transmit African swine fever virus’(8)
which includes an assessment of the animal health safety of the heat treatment for processed manure.
(5) Certain organic fertilisers and soil improvers require risk mitigation measures to reach an end point in the
manufacturing chain to ensure compliance with the feed ban laid down in Regulation (EC) No 999/2001. Under
Regulation (EU) No 142/2011, some of those organic fertilisers and soil improvers are required to be mixed with a
component that excludes the subsequent use of the mixture for feeding purposes to prevent the introduction of
certain transmissible spongiform encephalopathies through fertilisers into the feed chain for farmed animals. It is
appropriate to introduce a combination of the existing risk mitigation measures laid down in Regulation (EU)
No 142/2011, based on the packaging, labelling and composition.
(6) Derived products should be considered as having reached the end point only if they are manufactured in a fertiliser
plant in the Union which is approved in accordance with Article 24(1), point (f), of Regulation (EC) No 1069/2009.
An approved fertiliser plant is the last point in the manufacturing chain where derived products are subject to the
requirements laid down in Regulation (EC) No 1069/2009 and the place where they become, after reaching an end
point, only subject to those laid down in Regulation (EU) 2019/1009,
(3) EFSA Journal 2021;19(12):6932.
(4) 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).
(5) EFSA Journal 2015;13(11):4306.
(6) https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5314(EFSA Journal 2018;16(7):5314).
(7) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention,
control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).
(8) EFSA Journal 2021;19(4): 6558.8.8.2023 EN Official Journal of the European Union L 198/3
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter
This Regulation determines end points in the manufacturing chain for organic fertilisers and soil improvers manufactured
in the Union beyond which they are no longer subject to the requirements laid down in Regulation (EC) No 1069/2009,
provided that they are used as component materials in EU fertilising products in accordance with Regulation
(EU) 2019/1009.
Article 2
Definitions
For the purposes of this Regulation, the definitions laid down in Annex I to Regulation (EU) No 142/2011 apply.
The following definitions also apply:
1. ‘EU fertilising product’ means a fertilising product as defined in Article 2, point (2), of Regulation (EU) 2019/1009;
2. ‘end point’ means an end point in the manufacturing chain, beyond which a derived product is no longer subject to the
requirements of Regulation (EC) No 1069/2009.
Article 3
End point for certain organic fertilisers and soil improvers
The following derived products, other than those imported into the Union, where they are manufactured in a fertiliser plant
approved in accordance with Article 24(1), point (f), of Regulation (EC) No 1069/2009, shall be considered as having
reached the end point as organic fertilisers and soil improvers:
(a) ash obtained from Category 2 and 3 materials which fulfils the general and specific requirements set out in Annex III to
Regulation (EU) No 142/2011;
(b) residues resulting from the transformation of animal by-products in a biogas plant which fulfil the requirements set out
in the following provisions of Annex V to Regulation (EU) No 142/2011:
(i) Chapter I, Section 1, point 1, point 2(a), (b), (c) and (e), and points 3 and 4;
(ii) Chapter II;
(iii) Chapter III, Section 1, point 1, first and last paragraphs, and Section 3, point 1;
(c) compost, which fulfils the requirements, set out the following provisions of Annex V to Regulation (EU) No 142/2011:
(i) Chapter I, Section 2, points 1, 3 and 4;
(ii) Chapter II;
(iii) Chapter III, Section 1, point 2, and Section 3, point 1;
(d) processed manure and processed frass which fulfil the requirements set out in Chapter I, Section 2, points (a), (b), (d)
and (e), of Annex XI to Regulation (EU) No 142/2011.L 198/4 EN Official Journal of the European Union 8.8.2023
Article 4
End point for certain organic fertilisers and soil improvers conditional upon risk mitigation measures
1. The following derived products, other than those imported into the Union, where they are manufactured in a fertiliser
plant approved in accordance with Article 24(1), point (f), of Regulation (EC) No 1069/2009 shall be considered as having
reached the end point as organic fertilisers and soil improvers if they are used in the EU fertilising product in not more than
5 % by volume:
(a) glycerine of Category 2 and 3 materials, and other Category 2 material resulting from biodiesel process and the
production of renewable fuels which fulfil the requirements set out in Chapter IV, Section 3, point 2(b), (c) and (f), of
Annex IV to Regulation (EU) No 142/2011;
(b) Category 3 materials other than glycerine, which fulfil the requirements set out in Chapter IV, Section 3, point 2(b), (c)
and (f), of Annex IV to Regulation (EU) No 142/2011;
(c) processed animal protein of Category 3 materials which fulfils the specific requirements for processed animal protein
set out in Chapter II, Section 1, point A, point B(1) and (2), point B(3)(a) and point C, of Annex X to Regulation (EU)
No 142/2011;
(d) meat-and-bone meal of Category 2 materials processed with the standard processing method 1 set out in Chapter III,
point A, of Annex IV and marked with glyceroltriheptanoate (GTH) as set out in Chapter V of Annex VIII to Regulation
(EU) No 142/2011;
(e) blood products of Category 3 materials which fulfil the specific requirements for blood products set out in Chapter II,
Section 2, of Annex X to Regulation (EU) No 142/2011;
(f) hydrolysed protein, including hydrolysed protein derived from residues coming from the leather or textile industry,
which fulfils the specific requirements for hydrolysed protein set out in Chapter II, Section 5, point D, of Annex X to
Regulation (EU) No 142/2011;
(g) dicalcium phosphate and tricalcium phosphate which fulfil the specific requirements set out in Chapter II, Section 6 or
7, of Annex X to Regulation (EU) No 142/2011, respectively;
(h) horns, horn products, hooves and hoof products which fulfil the specific requirements set out in Chapter XII of Annex
XIII to Regulation (EU) No 142/2011.
2. The derived products referred to in paragraph 1 of this Article which are present in the EU fertilising product in more
than 5 % by volume shall be considered as having reached the end point as organic fertilisers and soil improvers if they are
packed in ready-to-sell packages for use by the end-user, labelled in accordance with labelling requirements for the EU
fertilising products containing derived products laid down in Part I of Annex III to Regulation (EU) 2019/1009 and
comply with the conditions laid down either in the following point (a) or in point (b):
(a) the packages weigh no more than 50 kg; or
(b) the packages weigh no more than 1 000kg of which at least 10 % in volume is one of the following:
(i) lime;
(ii) mineral fertilisers; or
(iii) derived products referred to in Article 3.
Article 5
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.8.8.2023 EN Official Journal of the European Union L 198/5
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 May 2023.
For the Commission
The President
Ursula VON DER LEYEN