Commission Delegated Regulation (EU) 2024/1682 of 4 March 2024 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

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 [^ntr1-L_202401682EN.000101-E0001], 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 [^ntr2-L_202401682EN.000101-E0002]. In accordance with Article 5 of Regulation (EC) No 1069/2009, the end point in the manufacturing chain for processed manure was determined in Commission Delegated Regulation (EU) 2023/1605 [^ntr3-L_202401682EN.000101-E0003].

• (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 [^ntr4-L_202401682EN.000101-E0004].

• (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 [^ntr5-L_202401682EN.000101-E0005] 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 organic matter and nutrients, in particular, nitrogen and phosphorus, two of the three primary macronutrients set out in Regulation (EU) 2019/1009. It has proven its agronomic value during a long history of use.

• (5) To ensure that an EU fertilising product containing processed manure maintains its content of nutrients over time, that its content of viable weed seeds or plant propagules is limited and that emissions of nutrients to the environment during storage are reduced, it is necessary to require processing in addition to the one needed to reach the end point in the manufacturing chain. Thus, the processed manure should be further processed to pass through a sieve with a mesh smaller to the known weed seeds dimensions, or be granulated or pelletised in certain conditions which ensure that weed seeds are no longer viable. Any other processing could also be used as long as it ensures that the content of viable weed seeds is limited. As an alternative, the processed manure could also be further processed to comply with one of the stability criteria laid down for Component Material Category 3, compost. This would ensure that the resulting material is stable, that decomposition would not continue after the product is placed on the market and that the weed seeds would no longer be viable after the composting process.

• (6) An additional safety criterion should be laid down to limit the content of 16 polycyclic aromatic hydrocarbons (PAH16) [^ntr6-L_202401682EN.000101-E0006] which may be generated during the processing of manure. Regulation (EU) 2019/1021 of the European Parliament and of the Council [^ntr7-L_202401682EN.000101-E0007] lays down release reduction requirements 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 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. To facilitate the conformity assessment procedure and avoid unnecessary costs, the possibility to assume compliance with this requirement without testing should be introduced, when it is clear from the manufacturing process that this limit value is met.

• (7) Processed manure may undergo additional processing to further improve its agronomic value or its safety. The processing methods which are currently widely used, such as solid-liquid separation, drying, pelletising, and recovery of nutrients, should be included in Component Material Category 10 in Annex II to Regulation (EU) 2019/1009. However, 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) 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 [^ntr8-L_202401682EN.000101-E0008], 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.

• (9) Furthermore, processed manure may be available on local markets in quantities that exceed demand. To ensure that its long-term storage under suboptimal conditions does not lead to adverse environmental impacts, it is appropriate to limit the time during which it can be used as a component material for EU fertilising products.

• (10) A general labelling requirement should be introduced for EU fertilising products containing processed manure to inform end-users about the potential air quality impacts of the release of ammonia from the use of processed manure and to invite them to apply appropriate measures to reduce such impacts.

• (11) Processed manure may contain aminopyralid or clopyralid, substances for which maximum residue levels for food and feed are set in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council [^ntr9-L_202401682EN.000101-E0009]. Users of EU fertilising products containing such processed manure should therefore be fully informed as regards the presence of those substances, so that they take the necessary measures to ensure that the resulting crop complies with the maximum residue levels.

• (12) 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, 4 March 2024.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202401682EN.000101-E0001]: OJ L 170, 25.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1009/oj.

[^ntr2-L_202401682EN.000101-E0002]: Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1069/oj).

[^ntr3-L_202401682EN.000101-E0003]: 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 (OJ L 198, 8.8.2023, p. 1, ELI: http://data.europa.eu/eli/reg_del/2023/1605/oj).

[^ntr4-L_202401682EN.000101-E0004]: Huygens, D, Technical proposals for processed manure as a component material for EU Fertilising Products.

[^ntr5-L_202401682EN.000101-E0005]: Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1, ELI: http://data.europa.eu/eli/dir/1991/676/oj).

[^ntr6-L_202401682EN.000101-E0006]: Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.

[^ntr7-L_202401682EN.000101-E0007]: Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45, ELI: http://data.europa.eu/eli/reg/2019/1021/oj).

[^ntr8-L_202401682EN.000101-E0008]: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

[^ntr9-L_202401682EN.000101-E0009]: Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/oj).

ANNEX I

In Part II of Annex II to Regulation (EU) 2019/1009, CMC 10 is replaced by the following:

‘ CMC 10: DERIVED PRODUCTS WITHIN THE MEANING OF REGULATION (EC) No 1069/2009

	1.	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: No The component material Additional requirements Processed manure fulfilling the conditions in Article 3(d) of Delegated Regulation (EU) 2023/1605[^ntr1-L_202401682EN.000401-E0001] 1.1. An EU fertilising product may contain processed manure only if it was treated to reach an end point according to Regulation (EC) No 1069/2009 at the latest 36 months before signing the EU declaration of conformity for the respective product and the material underwent additional processing so that at least one of the following conditions is met: (a) at least 90 % by dry mass of the material can pass through a sieve with a mesh of 0,25 mm; (b) the material has been granulated under pressure, pelletised, dried at temperatures higher than 100 °C or has undergone any equivalent process that ensures that the content of viable weed seeds and plant propagules in the processed manure is no more than 3 units/l; or (c) the material fulfills at least one of the stability criteria set out in point 5 of CMC 3. 1.2. The material referred to in point 1.1 may undergo one or more of the following additional processes: (a) the processing methods referred to in CMC 2; (b) biological treatment involving nitrification and denitrification; (c) mechanical separation of the solid and liquid fractions; (d) processes to recover nutrients and/or organic carbon, without the intention to otherwise modify the material; (e) chemical processing to modify the pH without the intention to otherwise modify the material; (f) physical processing to remove water and to transform the material into powder, granules or pellets, without the intention to otherwise modify the material. 1.3. Additives needed in the processing referred to in points 1.1 and 1.2 may be used provided that: (a) the additive complies with the requirement set out in point 2 of CMC 1; (b) the concentration of the additives needed in each of the processes does not exceed 5 % of the weight of the processed manure or fraction used as input in the respective process. 1.4. The processed manure shall contain no more than 6 mg/kg dry matter of PAH16 [^ntr2-L_202401682EN.000401-E0002]. 1.5. The processed manure to be used as component material in an EU fertilising product shall be stored in a way that protects it against precipitation and direct sunlight.

	2.	Where compliance with the requirement set out in point 1.4 follows certainly and uncontestably from the nature or the processing of the component material or the manufacturing process of the EU fertilising product, such compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer.’.

[^ntr1-L_202401682EN.000401-E0001]: 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 (OJ L 198, 8.8.2023, p. 1).

[^ntr2-L_202401682EN.000401-E0002]: Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.

ANNEX II

In Part I of Annex III to Regulation (EU) 2019/1009, the following points 7c and 7d are inserted:

• ‘7c. Where an EU fertilising product contains processed manure as referred to in Part II, CMC 10, of Annex II, information about the possible air quality impacts of the release of ammonia from the product’s use and an invitation to users to apply appropriate remediation measures shall be included on the label.

Where an EU fertilising product contains processed manure as referred to in Part II, CMC 10, of Annex II, the following warning shall be included on the label “This product may contain aminopyralid or clopyralid and must not be used for the production of plants susceptible to these substances, such as beans, clover, lentils, peas, salat, sunflowers and tomatoes. This product must be used in such a manner as to avoid leading to the exceedance of the maximum residue levels for food or feed set in accordance with Regulation (EC) 396/2005”, or a similar warning. Such a warning is not needed for EU fertilising products containing processed manure with no more than 50 μg aminopyralid or clopyralid/kg dry matter.

7d. Where an EU fertilising product contains a component material out of manure, the total content of nitrogen originated out of manure shall be indicated.’.

ELI: http://data.europa.eu/eli/reg_del/2024/1682/oj

ISSN 1977-0677 (electronic edition)