(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.

(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 2021 since 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,

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.

(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:

(c)

compost, which fulfils the requirements, set out the following provisions of Annex V to Regulation (EU) No 142/2011:

(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.