ANNEX
PART 1
Amendments to Annexes IV, V, XIV and XV to Regulation (EU) No 142/2011
Annexes IV, V, XIV and XV to Regulation (EU) No 142/2011 are amended as follows:
(1)
in Annex IV, Chapter IV is amended as follows:
(a)
Section 2 is amended as follows:
(i)
point D(2)(a)(ii) is replaced by the following:
‘(ii)
in the case of Category 3 materials, other than used cooking oil, any of the processing methods 1 to 5 or processing method 7 or, in the case of material derived from fish, processing methods 1 to 7 as set out in Chapter III;’;
(ii)
in point J(1)(a), the following subpoint is added:
‘(iv)
used cooking oil of Category 3 material.’;
(iii)
point L(1)(b) is replaced by the following:
‘(b)
used cooking oil of Category 3 material, rendered fats and fish oil complying with point J(1)(a) of this Section.’;
(iv)
the following points M and N are added:
‘M.
Production of biodiesel from processed fats derived from Category 1, 2 and 3 animal by-products
1.
Starting materials
For this process, rendered fats of Category 1, 2 or 3 material and used cooking oil of Category 3 material may be used.
2.
Processing methods
Except where fish oil are used which have been produced in accordance with Section VIII of Annex III to Regulation (EC) No 853/2004 ( *1 ) , or where rendered fat are used which have been produced in accordance with Section XII of Annex III to Regulation (EC) No 853/2004, the fat fraction derived from animal by-products shall be first processed using:
(a)
in the case of Category 1 or 2 materials, processing method 1 (pressure sterilisation) as set out in Chapter III of this Annex; and
(b)
in the case of Category 3 material, other than used cooking oil, any of the processing methods 1 to 5 or processing method 7 or, in the case of material derived from fish, processing methods 1 to 7 as set out in Chapter III of this Annex.
3.
After processing in accordance with one of the processing methods referred to in point 2, starting materials referred to in point 1 shall be subject to the following steps:
(a)
a pre-cleaning process for the removal of insoluble impurities in excess of 0,15 %. The resulting cleaned liquids obtained from the precleaning process shall be pumped to the biodiesel tank at the establishment where the cleaned liquids are stored, as biodiesel feedstocks, until processing;
(b)
an acidic esterification/transesterification (1,5 % methane sulfonic acid (MSA) w/w; 140 °C; 5,5 bar absolute pressure (bara); 4 hours) for conversion of the cleaned feedstock into biodiesel; and
(c)
fractional distillation: the biodiesel shall be fractionated (≥ 220 °C; 10 to 35 millibar (mbara)) into multiple refined products, each containing carbon chains of a particular length, resulting in batches of biodiesel with differing specifications.
4.
The competent authority shall assess the HACCP plan which checks and records the main processing parameters of the steps described in points 1, 2 and 3.
N.
Biodiesel production process using rendered fats of Category 1, 2 and 3 animal by-products
1.
Starting materials
For this process, a fat fraction derived from animal by-products of Category 1, 2 or 3 materials shall be used.
2.
Processing methods
(a)
Except where fish oil are used that have been produced in accordance with Section VIII of Annex III to Regulation (EC) No 853/2004, or where rendered fat are used which have been produced in accordance with Sections XII of Annex III to Regulation (EC) No 853/2004, the fat fraction derived from animal by-products shall be first processed using:
(i)
in the case of Category 1 or 2 materials, processing method 1 (pressure sterilisation) as set out in Chapter III of this Annex; and
(ii)
in the case of Category 3 material, other than used cooking oil, any of the processing methods 1 to 5 or processing method 7 or, in the case of material derived from fish, processing methods 1 to 7 as set out in Chapter III of this Annex; in the case of fat from ruminant origin, insoluble impurities in excess of 0,15 % by weight shall be removed.
(b)
The following biodiesel production process shall consist of a conversion phase of esterification and transesterification in a single step at a temperature of at least 200 °C, pressure of at least 70 bar with a retention time of at least 15 minutes, using MgO as a catalyst and in the presence of an alcohol (methanol) followed by vacuum distillation (at ≥ 150 °C, ≤ 10 mbar) of the end-product, biodiesel.
3.
The competent authority shall assess the HACCP plan which checks and records the main processing parameters of the steps described in points 1 and 2;
( *1 ) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( OJ L 139, 30.4.2004, p. 55 , ELI: http://data.europa.eu/eli/reg/2004/853/oj) .’;"
(b)
in Section 3, in point 2(b), the introductory sentence is replaced by the following:
‘the biodiesel production process referred to in Section 2, points D, M and N, may be:’;
(2)
in Annex V, in Chapter I, in Section 1, in point 2, the following point (g) is added:
‘(g)
processed frass that has been processed in accordance with Annex XI, Chapter I, Section 2, point (b);’;
(3)
Annex XIV is amended as follows:
(a)
in Chapter I, in Section 2, point 5(a) is replaced by the following:
‘5.
Processed animal protein obtained from farmed insects may be imported into the Union provided that it has been produced in compliance with the following conditions:
(a)
the insects belong to one of the following species:
—
black soldier fly ( Hermetia illucens ) and common housefly ( Musca domestica ),
—
yellow mealworm ( Tenebrio molitor ) and lesser mealworm ( Alphi tobius diaperinus ),
—
house cricket ( Acheta domesticus ), banded cricket ( Gryllodes sigillatus ) and field cricket ( Gryllus assimilis ),
—
silkworm ( Bombyx mori );’;
(b)
in Chapter II, in Section 1, Table 2 is amended as follows:
(i)
in row 12, in the fifth column entitled ‘Third countries’ lists’, point (b) is replaced by the following:
‘(b)
In the case of dogchews and petfood other than raw petfood:
Third countries listed in Part 1 of Annex XIII, in Part 1 of Annex XIV, or in Part 1, Section A, of Annex XV to Implementing Regulation (EU) 2021/404, and the following third countries:
(AL)
Albania
(EC)
Ecuador
(DZ)
Algeria
(GE)
Georgia (only processed petfood other than canned petfood)
(LK)
Sri Lanka
(SA)
Saudi Arabia (only processed petfood of poultry origin)
(SV)
El Salvador
(TW)
Taiwan
(ID)
Indonesia (only processed petfood containing processed animal protein of insect origin)
In the case of fish material, third countries listed in Annex IX to Implementing Regulation (EU) 2021/405.’;
(ii)
in row 17, in the third column entitled ‘Raw materials (references to provisions of Regulation (EC) No 1069/2009)’, point (a) is replaced by the following:
‘(a)
In the case of materials destined for the production of biodiesel, biodiesel oleochemical products or renewable fuels referred to in points L, M and N of Section 2 of Chapter IV of Annex IV:
Categories 1, 2 and 3 materials referred to in Articles 8, 9 and 10.’;
(c)
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
Jellice Co., Ltd. 4-1, Sakae 4-Chome, Tagajo-City, Miyagi 985-0833 Japan
The Netherlands
Rotterdam
airport Schiphol – Amsterdam
Fujifilm Manufacturing Europe B.V., 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’
(4)
Annex XV to Regulation (EU) No 142/2011 is amended as follows:
(a)
Chapter 1a is replaced by the following:
‘
CHAPTER 1a
Health certificate
For processed animal protein derived from farmed insects not intended for human consumption, including mixtures and products other than petfood containing such protein, for dispatch to or for transit through 2 the European Union
’
(b)
Chapter 17 is replaced by the following:
‘CHAPTER 17
Health certificate
For processed manure, derived products from processed manure, processed frass and processed guano from bats intended for dispatch to or for transit through 2 the European Union
’
PART 2
Correction to Annex XIV to Regulation (EU) No 142/2011
In Annex XIV, in Chapter II, in Section 1, in Table 2, in row 14, in the fifth column entitled ‘Third countries lists’, point (b) is corrected and replaced by the following:
‘(b)
In the case of animal by-products for the manufacture of pharmaceuticals:
Third countries listed in Part 1 of Annex XIII or in Part 1 of Annex XIV to Implementing Regulation (EU) 2021/404; and in Annexes I, V, and VI to Implementing Regulation (EU) 2021/405.
In the case of material from fish, third countries listed in Annex IX to Implementing Regulation (EU) 2021/405.’.
( *1 ) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( OJ L 139, 30.4.2004, p. 55 , ELI: http://data.europa.eu/eli/reg/2004/853/oj) .’;’
