# L_2021393EN.01000401.xml

| 8.11.2021 | EN | Official Journal of the European Union | L 393/4 |
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8.11.2021

EN

Official Journal of the European Union

L 393/4

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COMMISSION REGULATION (EU) 2021/1925

of 5 November 2021

amending certain Annexes to Regulation (EU) No 142/2011 as regards the requirements for placing on the market of certain insect products and the adaptation of a containment method

(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 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 (1), and in particular Article 15(1), first subparagraph, points (b), (h), (i) and (j), Article 21(6), first subparagraph, point (d), Article 27, first subparagraph, point (c), Article 31(2), and Article 32(3), first subparagraph, point (a) thereof,

Whereas:

| (1) | Commission Regulation (EU) No 142/2011 (2) lays down public and animal health rules for the placing on the market and export of derived products. |
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(1)

Commission Regulation (EU) No 142/2011 (2) lays down public and animal health rules for the placing on the market and export of derived products.

| (2) | The fast development of the insect producing sector has resulted in a significant amount of insect excrements, which, in the absence of harmonised Union rules, are disposed of differently in each Member State. To ensure the valorisation of insect excrements as fertilisers it is necessary to lay down Union rules. |
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(2)

The fast development of the insect producing sector has resulted in a significant amount of insect excrements, which, in the absence of harmonised Union rules, are disposed of differently in each Member State. To ensure the valorisation of insect excrements as fertilisers it is necessary to lay down Union rules.

| (3) | For the purpose of Regulation (EU) No 142/2011, ‘frass’
  should be defined as the mixture of insect excrements with parts of dead insects and feeding substrate. Insect larvae, which are commonly used for the production of processed animal protein or for human consumption, live in the frass. A definition of ‘frass’ should be inserted in Annex I to Regulation (EU) No 142/2011 in order to align the requirements for the treatment and placing on the market of frass with the requirements for processed manure. Annex I to Regulation (EU) No 142/2011 should therefore be amended accordingly. |
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(3)

For the purpose of Regulation (EU) No 142/2011, ‘frass’
  should be defined as the mixture of insect excrements with parts of dead insects and feeding substrate. Insect larvae, which are commonly used for the production of processed animal protein or for human consumption, live in the frass. A definition of ‘frass’ should be inserted in Annex I to Regulation (EU) No 142/2011 in order to align the requirements for the treatment and placing on the market of frass with the requirements for processed manure. Annex I to Regulation (EU) No 142/2011 should therefore be amended accordingly.

| (4) | The timely collection of single carcases of non-ruminant farmed animal is not always economically feasible, in particular as regards carcases collected from small farms. Therefore, Chapter V of Annex IX to Regulation (EU) No 142/2011 provides for containment methods to ensure the safe storage of certain dead non-ruminant farmed animals until collection. The containment method ‘Hydrolysis with subsequent disposal’ currently only covers carcases of porcine animals. It is appropriate to extend that containment method to also include carcases of poultry and farmed lagomorphs. Point 2 of Section 2.B of Chapter V of Annex IX to Regulation (EU) No 142/2011 should therefore be amended accordingly. |
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(4)

The timely collection of single carcases of non-ruminant farmed animal is not always economically feasible, in particular as regards carcases collected from small farms. Therefore, Chapter V of Annex IX to Regulation (EU) No 142/2011 provides for containment methods to ensure the safe storage of certain dead non-ruminant farmed animals until collection. The containment method ‘Hydrolysis with subsequent disposal’ currently only covers carcases of porcine animals. It is appropriate to extend that containment method to also include carcases of poultry and farmed lagomorphs. Point 2 of Section 2.B of Chapter V of Annex IX to Regulation (EU) No 142/2011 should therefore be amended accordingly.

| (5) | In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (Withdrawal Agreement), and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, Regulation (EC) No 1069/2009, as well as the Commission acts based on it, apply to and in the United Kingdom in respect of Northern Ireland after the end of the transition period provided for in the Withdrawal Agreement. |
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(5)

In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (Withdrawal Agreement), and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, Regulation (EC) No 1069/2009, as well as the Commission acts based on it, apply to and in the United Kingdom in respect of Northern Ireland after the end of the transition period provided for in the Withdrawal Agreement.

| (6) | As the transition period provided for in the Withdrawal Agreement ended on 31 December 2020, point 1 of Section 2.B of Chapter V of Annex IX to Regulation (EU) No 142/2011 should be amended in order to replace the reference to the United Kingdom in the list of Member States authorised to apply the containment method by a reference to United Kingdom in respect of Northern Ireland. Furthermore, references to the United Kingdom in Section 2.A of Chapter V of Annex IX to Regulation (EU) No 142/2011 and in Table 3 of Section 11 of Chapter II of Annex XIV to that Regulation should be deleted. |
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(6)

As the transition period provided for in the Withdrawal Agreement ended on 31 December 2020, point 1 of Section 2.B of Chapter V of Annex IX to Regulation (EU) No 142/2011 should be amended in order to replace the reference to the United Kingdom in the list of Member States authorised to apply the containment method by a reference to United Kingdom in respect of Northern Ireland. Furthermore, references to the United Kingdom in Section 2.A of Chapter V of Annex IX to Regulation (EU) No 142/2011 and in Table 3 of Section 11 of Chapter II of Annex XIV to that Regulation should be deleted.

| (7) | On 8 October 2015, the European Food Safety Authority (EFSA) published a scientific opinion on a risk profile related to the production and consumption of insects as food and feed (3). Among several insect species, the EFSA assessed silkworms as a possible source for the production of processed animal protein. Sericulture has a long-standing tradition in certain regions of the Union. Since the domestic silkworm consumes only mulberry leaves (Morus alba and Morus nigra), there is no risk of contamination with feed of animal origin, which is not authorised for the feeding of insects. It should therefore be authorised for processing into processed animal protein intended for the manufacturing of feed for farmed animals, after the silk has been harvested. It is appropriate to add silkworms (Bombyx mori) to the list of authorised insect species for the production of processed animal protein intended for the manufacturing of feed for farmed animals. Annex X to Regulation (EU) No 142/2011 should therefore be amended accordingly. |
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(7)

On 8 October 2015, the European Food Safety Authority (EFSA) published a scientific opinion on a risk profile related to the production and consumption of insects as food and feed (3). Among several insect species, the EFSA assessed silkworms as a possible source for the production of processed animal protein. Sericulture has a long-standing tradition in certain regions of the Union. Since the domestic silkworm consumes only mulberry leaves (Morus alba and Morus nigra), there is no risk of contamination with feed of animal origin, which is not authorised for the feeding of insects. It should therefore be authorised for processing into processed animal protein intended for the manufacturing of feed for farmed animals, after the silk has been harvested. It is appropriate to add silkworms (Bombyx mori) to the list of authorised insect species for the production of processed animal protein intended for the manufacturing of feed for farmed animals. Annex X to Regulation (EU) No 142/2011 should therefore be amended accordingly.

| (8) | Annex XI to Regulation (EU) No 142/2011 sets out the requirements for the placing on the market of manure. Following the introduction of the definition of ‘frass’ in Annex I to that Regulation, the requirements for the placing on the market of processed frass should ensure safe trade in processed frass. Therefore, the requirements laid down in that Annex should also cover frass. Annex XI to Regulation (EU) No 142/2011 should therefore be amended accordingly. |
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(8)

Annex XI to Regulation (EU) No 142/2011 sets out the requirements for the placing on the market of manure. Following the introduction of the definition of ‘frass’ in Annex I to that Regulation, the requirements for the placing on the market of processed frass should ensure safe trade in processed frass. Therefore, the requirements laid down in that Annex should also cover frass. Annex XI to Regulation (EU) No 142/2011 should therefore be amended accordingly.

| (9) | Member States that currently apply national measures for the processing of frass should align their national measures with the method laid down in Annex XI to Regulation (EU) No 142/2011, as amended by this Regulation. This Regulation should provide for a transitional period of 12 months. |
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(9)

Member States that currently apply national measures for the processing of frass should align their national measures with the method laid down in Annex XI to Regulation (EU) No 142/2011, as amended by this Regulation. This Regulation should provide for a transitional period of 12 months.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I, IX, X, XI and XIV to Regulation (EU) No 142/2011 are amended in accordance with the Annex to this Regulation.

Article 2

Operators approved or registered in a Member State that applies national measures for the processing of frass may continue to apply those national measures for the placing on the market of frass within the concerned Member State until 8 November 2022.

Article 3

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, 5 November 2021.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 300, 14.11.2009, p. 1.

1

(2)  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).

2

(3)  Scientific Opinion on a Risk profile related to production and consumption of insects as food and feed, The EFSA Journal (2015);13 (10):4257.

3

The EFSA Journal

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ANNEX

Annexes I, IX, X XI and XIV to Regulation (EU) No 142/2011 are amended as follows:

| (1) | in Annex I, the following point 61 is added:






  ‘61. | “frass” means a mixture of excrements derived from farmed insects, the feeding substrate, parts of farmed insects, dead eggs and with a content of dead farmed insects of not more than 5 % in volume and not more than 3 % in weight.’; |
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(1)

in Annex I, the following point 61 is added:

‘61.

“frass” means a mixture of excrements derived from farmed insects, the feeding substrate, parts of farmed insects, dead eggs and with a content of dead farmed insects of not more than 5 % in volume and not more than 3 % in weight.’;

| (2) | in Annex IX, in Chapter V, Section 2 is amended as follows:






  (a) | point A.1 is replaced by the following:






  ‘1. | Member States (*1) concerned
  The process of aerobic maturation and storage of dead-on-farm pigs and certain other porcine material with subsequent incineration or co-incineration may be used in France, Ireland, Latvia, Portugal and the United Kingdom in respect of Northern Ireland.
  Following aerobic maturation and storage of material, the competent authority of the Member State concerned must ensure that the materials are collected and disposed of within the territory of that Member State. |
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(2)

in Annex IX, in Chapter V, Section 2 is amended as follows:

(a)

point A.1 is replaced by the following:

‘1.

Member States (*1) concerned

The process of aerobic maturation and storage of dead-on-farm pigs and certain other porcine material with subsequent incineration or co-incineration may be used in France, Ireland, Latvia, Portugal and the United Kingdom in respect of Northern Ireland.

Following aerobic maturation and storage of material, the competent authority of the Member State concerned must ensure that the materials are collected and disposed of within the territory of that Member State.

(*1)  In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex, references to Member States include the United Kingdom in respect of Northern Ireland.’;"

| (b) | points B.1 and B.2 are replaced by the following:






  ‘1. | Member States (*2) concerned
  The process of hydrolysis with subsequent disposal may be used in Ireland, Spain, Latvia, Portugal and the United Kingdom in respect of Northern Ireland.
  Following hydrolysis, the authorising competent authority must ensure that the materials are collected and disposed of within the same Member State referred to above. |
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(b)

points B.1 and B.2 are replaced by the following:

‘1.

Member States (*2) concerned

The process of hydrolysis with subsequent disposal may be used in Ireland, Spain, Latvia, Portugal and the United Kingdom in respect of Northern Ireland.

Following hydrolysis, the authorising competent authority must ensure that the materials are collected and disposed of within the same Member State referred to above.

| 2. | Starting materials
  For this process, only the following materials of porcine, poultry or farmed lagomorph species may be used:






  (a) | Category 2 materials referred to in Article 9, points (f)(i), (ii) and (iii), of Regulation (EC) No 1069/2009; |
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2.

Starting materials

For this process, only the following materials of porcine, poultry or farmed lagomorph species may be used:

(a)

Category 2 materials referred to in Article 9, points (f)(i), (ii) and (iii), of Regulation (EC) No 1069/2009;

| (b) | Category 3 materials referred to in Article 10, point (h), of that Regulation. |
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(b)

Category 3 materials referred to in Article 10, point (h), of that Regulation.

This method shall only be applied for the disposal of animals of the porcine, poultry or farmed lagomorph species originating in the same holding provided that this holding is not subject to a prohibition due to a suspected or confirmed outbreak of a serious transmissible disease affecting animals of the porcine, poultry or farmed lagomorph species, and animals have not been killed for disease control purposes.

(*2)  In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex, references to Member States include the United Kingdom in respect of Northern Ireland.’;"

| (3) | in Annex X, in Chapter II, in Section 1.A, in point 2, the following point (iv) is added:






  ‘(iv) | Silkworm (Bombyx mori).’; |
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(3)

in Annex X, in Chapter II, in Section 1.A, in point 2, the following point (iv) is added:

‘(iv)

Silkworm (Bombyx mori).’;

| (4) | in Annex XI, in Chapter I, Section 2 is amended as follows:






  (a) | the title and the introductory paragraph are replaced by the following:

  ‘
  Section 2


  Guano from bats, frass, processed manure and derived products from processed manure

  The placing on the market of guano from bats, processed manure, and derived products from processed manure shall be subject to the conditions set out in the following points (a) to (e). In addition, in the case of guano from bats the consent of the Member State of destination shall be required as referred to in Article 48(1) of Regulation (EC) No 1069/2009:’; |
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(4)

in Annex XI, in Chapter I, Section 2 is amended as follows:

(a)

the title and the introductory paragraph are replaced by the following:

‘
  Section 2

Guano from bats, frass, processed manure and derived products from processed manure

The placing on the market of guano from bats, processed manure, and derived products from processed manure shall be subject to the conditions set out in the following points (a) to (e). In addition, in the case of guano from bats the consent of the Member State of destination shall be required as referred to in Article 48(1) of Regulation (EC) No 1069/2009:’;

| (b) | the following point (f) is added:






  ‘(f) | The placing on the market of frass shall be subject to the conditions set out in points (a), (b), (d) and (e) of this Section.’; |
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(b)

the following point (f) is added:

‘(f)

The placing on the market of frass shall be subject to the conditions set out in points (a), (b), (d) and (e) of this Section.’;

| (5) | in Annex XIV, in Chapter II, in Section 11, Table 3 is replaced by the following:
  ‘Table 3


  Imports of photogelatine










  Third country of origin | Plants of origin | Member State of destination | Border inspection post of first entry into the Union | Approved photographic factories |
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| Japan | Nitta Gelatin Inc., 2-22 Futamata Yao-City, Osaka 581-0024 Japan
  Jellie Co. Ltd. 7-1, Wakabayashi 2-Chome, Wakabayashi-ku, Sendai-City; Miyagi, 982 Japan
  NIPPI Inc. Gelatine Division 1 Yumizawa-Cho Fujinomiya City Shizuoka 18-0073 Japan | The Netherlands | Rotterdam | FujifilmEurope, Oudenstaart 1, 5047 TK Tilburg, The Netherlands |
| Nitta Gelatin Inc., 2-22 Futamata Yao-City, Osaka 581-0024 Japan | | | |
| Czechia | Hamburg | FOMA Bohemia, spol. SRO Jana Krušinky 1604 501 04 Hradec Králové, Czechia |
| United States | Eastman Gelatine Corporation, 227 Washington Street, Peabody, MA, 01960 USA
  Gelita North America, 2445 Port Neal Industrial Road Sergeant Bluff, Iowa, 51054 USA | | | |
| Czechia | Hamburg | FOMA Bohemia spol. SRO Jana Krušinky 1604 501 04 Hradec Králové, Czechia’ |

(5)

in Annex XIV, in Chapter II, in Section 11, Table 3 is replaced by the following:

‘Table 3

Imports of photogelatine

Third country of origin

Plants of origin

Member State of destination

Border inspection post of first entry into the Union

Approved photographic factories

Japan

Nitta Gelatin Inc., 2-22 Futamata Yao-City, Osaka 581-0024 Japan

Jellie Co. Ltd. 7-1, Wakabayashi 2-Chome, Wakabayashi-ku, Sendai-City; Miyagi, 982 Japan

NIPPI Inc. Gelatine Division 1 Yumizawa-Cho Fujinomiya City Shizuoka 18-0073 Japan

The Netherlands

Rotterdam

FujifilmEurope, Oudenstaart 1, 5047 TK Tilburg, The Netherlands

Nitta Gelatin Inc., 2-22 Futamata Yao-City, Osaka 581-0024 Japan

Czechia

Hamburg

FOMA Bohemia, spol. SRO Jana Krušinky 1604 501 04 Hradec Králové, Czechia

United States

Eastman Gelatine Corporation, 227 Washington Street, Peabody, MA, 01960 USA

Gelita North America, 2445 Port Neal Industrial Road Sergeant Bluff, Iowa, 51054 USA

Czechia

Hamburg

FOMA Bohemia spol. SRO Jana Krušinky 1604 501 04 Hradec Králové, Czechia’

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(*1)  In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex, references to Member States include the United Kingdom in respect of Northern Ireland.’;

(*2)  In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex, references to Member States include the United Kingdom in respect of Northern Ireland.’;”

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