EXPLANATORY MEMORANDUM
1.CONTEXT OF THE DELEGATED ACT
Animal by-products within the meaning of Regulation (EC) No 1069/2009 are entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption. Derived products are products obtained from one or more treatments, transformations or steps of processing of animal by-products. Derived products have a long tradition of use as national organic fertilisers and soil improvers, under the conditions laid down in Regulation (EC) No 1069/2009 and the national rules on fertilising products.
Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. EU fertilising products are CE-marked and move freely in the internal market. They 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, provided that such derived products are listed in the table in Component Material Category 10 in Annex II to Regulation (EU) 2019/1009.
The end point in the manufacturing chain is the moment as of when the derived products are no longer subject to the veterinary controls set out in Regulation (EC) No 1069/2009. As mentioned in the Communication on the availability and affordability of fertilisers, the definition of such end points constitutes an important step towards promoting green and circular alternatives to natural gas and mined raw materials for fertiliser production.
Pursuant to Article 5 of Regulation (EC) No 1069/2009, the Commission assessed derived products that are already widely used in the Union as organic fertilisers and soil improvers, including processed manure.
The Commission determined the end point in the manufacturing chain for processed manure in Delegated Regulation (EU) 2023/1605.
In accordance with Article 42(5) of Regulation (EU) 2019/1009, the Commission’s Joint Research Centre assessed processed manure with respect to relevant aspects not taken into account for the purpose of determining an end point in the manufacturing chain in accordance with Regulation (EC) No 1069/2009.
This delegated Regulation lists processed manure in the table in Component Material Category 10 and sets out the requirements needed to ensure that EU fertilising products containing this component material are safe and agronomically efficient.
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 2016.
Details of these consultations can be found in the minutes of the meetings held on 8 December 2022 and 18-19 April 2023, 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 supportive of the adoption of this delegated Regulation.
The draft delegated Regulation has been published for feedback on the Better Regulation portal. [add details]
The draft delegated Regulation has also been notified based on Article 2(9)(2) of the Agreement on Technical Barriers to Trade. [add details]
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. Article 42(5) of Regulation (EU) 2019/1009 provides further rules for adding derived products in Annex II of that Regulation.
COMMISSION DELEGATED REGULATION (EU) …/...
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amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards adding processed manure as a component material in EU fertilising products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having 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 2003/2003, 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 products. EU fertilising products may contain derived products within the meaning of Regulation (EC) No 1069/2009 of the European Parliament and of the Council. In accordance with Article 5 of Regulation (EC) 1069/2009, the end point in the manufacturing chain for processed manure was determined in Commission Delegated Regulation (EU) 2023/1605.
(2)In accordance with Article 42(5), second subparagraph, of Regulation (EU) 2019/1009, the Commission’s Joint Research Centre (JRC) assessed processed manure with respect to relevant aspects not taken into account for the purpose of determining an end point in the manufacturing chain.
(3)Processed manure has the potential to be subject to significant trade in the internal market as it is a derived product commonly used in the organic fertilisers and soil improvers. Laying down the requirements for the CE-marking of EU fertilising products containing processed manure would facilitate the trade of such products in the internal market. JRC concluded that the introduction of processed manure in Component Material Category 10 in Annex II to Regulation (EU) 2019/1009 would also facilitate the implementation of Council Directive 91/676/EEC by promoting the transfer of processed manure from regions with a high density of nutrients to those with a low density.
(4)Processed manure contains nitrogen and phosphorus, two of the three primary macronutrients. It has proven its agronomic value during a long history of use in the field.
(5)To ensure that an EU fertilising product containing processed manure maintains its nutrient content over time, and thus its agronomic value, a stability criterion should be set out. Such a criterion should ensure that the processed manure has a low degree of organic matter decomposition. In addition to safeguarding the agronomic value of the products, it is possible that such a criterion would also imply additional processing to reduce the survival of weed seeds and would avoid nutrient emissions to the environment during storage.
(6)An additional safety criterion should be laid down to limit the content of 16 polycyclic aromatic hydrocarbons (PAH16) which may be generated during the processing of manure. Regulation (EU) 2019/1021 of the European Parliament and of the Council lays down release reductions for PAH16 as unintentionally produced substances during manufacturing processes, but does not introduce a limit value in such cases. Given the high risks generated by the presence of such pollutants in fertilising products, it is considered appropriate to introduce more stringent requirements than those laid down in Regulation (EU) 2019/1021. Such a limit value should be laid down at component material level, to ensure coherence with Regulation (EU) 2019/1021 and should apply in addition to the safety criteria laid down in Annex I to Regulation (EU) 2019/1009 for the corresponding product function category.
(7)Processed manure may undergo additional processing to further improve its agronomic value or its safe handling. The processing methods which are currently widely used, such as solid-liquid separation, drying, pelletising, should be included in Regulation (EU) 2019/1009. As an additional safety measure, the additives needed in the processing of manure should be registered based on Regulation (EC) No 1907/2006 of the European Parliament and of the Council, in the extensive conditions already laid down in Regulation (EU) 2019/1009 for additives in other component material categories. That would ensure that the manufacturers take into account the use of the additives in a fertilising product when performing the risk assessment under Regulation (EC) No 1907/2006 and that the registration is done also for low tonnage materials. The manure processing steps should not include thermochemical conversion processes at high temperatures or pressures, such as liquefaction, hydrothermal carbonisation, pyrolysis, gasification or combustion, as such processes are covered under other component material categories due to the specific nature of the material transformation process.
(8)Furthermore, processed manure may be available on local markets in quantities that exceed demand. To ensure that market demand for processed manure exists and that its long-term storage under suboptimal conditions does not lead to adverse environmental impacts, it is appropriate to limit the period of time during which it can be used as a component material for EU fertilising products.
(9)A general labelling requirement should be introduced for EU fertilising products containing processed manure to inform end users about the potential negative impact of processed manure on air quality and to invite them to take appropriate measures to reduce such impact.
(10)Processed manure may contain aminopyralid or clopyralid, substances for which maximum residue levels for food and feed are set in accordance with Regulation (EC) 396/2005. Users of EU fertilising products containing such processed manure should therefore be fully informed as regards the presence of these substances, so that they take the necessary measures to ensure that the resulting crop complies with those maximum residue levels.’.
(11)Regulation (EU) 2019/1009 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) 2019/1009 is amended as follows:
(1)Annex II is amended in accordance with Annex I to this Regulation;
(2)Annex III is amended in accordance with Annex II 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.
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
