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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 (Text with EEA relevance)
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As referred to in Article 41(1)(a) and Article 41(3) of Regulation (EC) No 1069/2009, the following requirements shall apply to imported consignments of Category 3 material and derived products therefrom for uses in the feed chain other than for petfood or for feed to fur animals and consignments of such materials and products in transit:
they must consist of or have been produced from, as applicable, Category 3 material referred to in the column ‘raw materials’ of Table 1;
they must comply with the import and transit conditions set out in the column ‘import and transit conditions’ of Table 1;
[F1they must come from a third country or part of a third country listed in the column ‘ third countries’ list ’ of Table 1;
they must come from an establishment or plant which is registered or approved by the competent authority of the third country, as applicable, and which is on the list of such establishments and plants referred to in Article 30; and
they must be:
accompanied during transportation to the point of entry into the Union where the veterinary checks take place by the health certificate referred to in the column ‘ certificates/model documents ’ of Table 1; or
presented at the point of entry into the Union where the veterinary checks take place accompanied by a document corresponding to the model referred to in the column ‘ certificates/model documents ’ of Table 1.]
[F2. . . . .]
Textual Amendments
F1 Substituted by Commission Regulation (EU) No 294/2013 of 14 March 2013 amending and correcting Regulation (EU) No 142/2011 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 (Text with EEA relevance).
F2 Deleted by Commission Regulation (EU) No 294/2013 of 14 March 2013 amending and correcting Regulation (EU) No 142/2011 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 (Text with EEA relevance).
No | Product | Raw materials (reference to provisions of Regulation (EC) No 1069/2009) | Import and transit conditions | Third countries’ lists | Certificates/model documents |
---|---|---|---|---|---|
[F31 | Processed animal protein, including mixtures and products other than petfood containing such protein, and compound feeds containing such proteins as defined in Article 3(2)(h) of Regulation (EC) No 767/2009 | Category 3 materials referred to in Article 10(a), (b), (d), (e), (f), (h), (i), (j), (k), (l) and (m). | (a) The processed animal protein must have been produced in accordance with Section 1 of Chapter II of Annex X; and (b) the processed animal protein shall comply with the additional requirements set out in Section 2 of this Chapter. | (a) In the case of processed animal proteins excluding fishmeal: Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010. (b) In the case of fishmeal: Third countries listed in Annex II to Decision 2006/766/EC. | (a) In the case of processed animal protein other than those derived from farmed insects: Annex XV, Chapter 1. (b) In the case of processed animal protein derived from farmed insects: Annex XV, Chapter 1a.] |
2 | Blood products for feed material | Category 3 materials referred to in Article 10 (a) and (b)(i). | [F4The blood products must have been produced in accordance with Section 2 of Chapter II of Annex X and Section 5 of Chapter I of Annex XIV.] | (a)In the case of blood products from ungulates:Third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which imports of all categories of fresh meat of the respective species are authorised. (b)In the case of blood products from other species:Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010. | Annex XV, Chapter 4(B). |
3 | Rendered fats and fish oil | (a)In the case of rendered fats excluding fish oil: Category 3 materials referred to in Article 10(a), (b), (d), (e), (f), (g), (h), (i), (j) and (k).(b)In the case of fish oil: Category 3 materials referred to in Article 10(e), (f), (i) and (j). | (a)The rendered fat and the fish oil must have been produced in accordance with Section 3 of Chapter II of Annex X; and(b)The rendered fat shall comply with the additional requirements set out in Section 3 of this Chapter. | (a)In the case of rendered fats excluding fish oil:Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010. (b)In the case of fish oil:Third countries listed in Annex II to Decision 2006/766/EC. | (a)In the case of rendered fats excluding fish oil:Annex XV, Chapter 10 (A). (b)In the case of fish oil:Annex XV, Chapter 9. |
4 | Milk, milk-based products and milk-derived products, colostrum, colostrum products | (a)Milk, milk-based products:Category 3 materials referred to in Article 10(e), (f) and (h). (b)Colostrum, colostrum productsCategory 3 materials from live animals that did not show any signs of disease transmissible through the colostrums to humans or animals. | The milk, milk-based products, colostrum and colostrum products shall comply with the requirements set out in Section 4 of this Chapter. | (a)In the case of milk and milk-based products:Authorised third countries listed in Annex I to Regulation (EU) No 605/2010. (b)In the case of colostrum and colostrum products:Third countries listed as authorised in column ‘A’ of Annex I to Regulation (EU) No 605/2010. | (a)In the case of milk, milk-based products and milk-derived products:Annex XV, Chapter 2(A). (b)In the case of colostrum and colostrums products:Annex XV, Chapter 2(B). |
[F55 | Gelatine and hydrolysed protein | Category 3 materials referred to in Article 10(a), (b), (e), (f), (g), (i) and (j), and, in the case of hydrolysed protein: Category 3 materials referred to in Article 10(d), (h) and (k). | The gelatine and the hydrolysed protein must have been produced in accordance with Section 5 of Chapter II of Annex X. | (a) Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, and the following countries:
(b) In the case of gelatine and hydrolysed proteins from fish: Third countries listed in Annex II to Decision 2006/766/EC. | (a) In the case of gelatine: Annex XV, Chapter 11.(b) In the case of hydrolysed protein: Annex XV, Chapter 12.] |
6 | Dicalcium phosphate | Category 3 materials referred to in Article 10(a), (b), (d),(e), (f), (g), (h), (i), (j) and (k). | The dicalcium phosphate must have been produced in accordance with Section 6 of Chapter II of Annex X. | Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, and the following countries:
| Annex XV, Chapter 12. |
7 | Tricalcium phosphate | Category 3 materials referred to in Article 10(a), (b), (d),(e), (f), (g), (h), (i) and (k). | The tricalcium phosphate must have been produced in accordance with Section 7 of Chapter II of Annex X. | Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, and the following countries:
| Annex XV, Chapter 12. |
8 | Collagen | Category 3 materials referred to in Article 10(a), (b), (e), (f), (g), (i) and (j). | The collagen must have been produced in accordance with Section 8 of Chapter II of Annex X. | Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, and the following countries:
| Annex XV, Chapter 11. |
9 | Egg products | Category 3 materials referred to in Article 10(e), (f) and (k)(ii). | The egg products must have been produced in accordance with Section 9 of Chapter II of Annex X. | Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, and third countries or parts of third countries from which Member States authorise imports of fresh poultrymeat, eggs and egg products, which are listed in Part 1 of Annex I to Regulation (EC) No 798/2008. | Annex XV, Chapter 15. |
Textual Amendments
F3 Substituted by Commission Regulation (EU) 2017/893 of 24 May 2017 amending Annexes I and IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annexes X, XIV and XV to Commission Regulation (EU) No 142/2011 as regards the provisions on processed animal protein (Text with EEA relevance).
F4 Substituted by Commission Regulation (EU) 2015/9 of 6 January 2015 amending Regulation (EU) No 142/2011 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 (Text with EEA relevance).
The following requirements shall apply to the importation of processed animal protein:
Before consignments are released for free circulation within the Union, the competent authority must sample processed animal protein from imported consignments at the border inspection post to ensure compliance with the general requirements of Chapter I of Annex X.
The competent authority must:
sample each consignment of products carried in bulk;
carry out random sampling of consignments of products packaged in the manufacturing plant of origin.
By way of derogation from point 1, when six consecutive tests on bulk consignments originating in a given third country prove negative, the competent authority of the border inspection post may carry out random sampling of subsequent bulk consignments from that third country.
If one of those random samples proves positive, the competent authority carrying out the sampling must inform the competent authority of the third country of origin so that it can take appropriate measures to remedy the situation.
The competent authority of the third country of origin must bring these measures to the attention of the competent authority carrying out the sampling.
In the event of a further positive result from the same source, the competent authority of the border inspection post must sample each consignment from the same source until six consecutive tests again prove negative.
Competent authorities must keep a record for at least three years of the results of sampling carried out on all consignments that have undergone sampling.
Where a consignment imported into the Union proves to be positive for salmonella or where it does not meet the microbiological standards for enterobacteriaceae set out in Chapter I of Annex X, it must either:
be dealt with in accordance with the procedure laid down by Article 17(2)(a) of Directive 97/78/EC; or
reprocessed in a processing plant or decontaminated by a treatment authorised by the competent authority. The consignment must not be released until it has been treated, tested for salmonella or enterobacteriaceae, as necessary, by the competent authority in accordance with Chapter I of Annex X, and a negative result obtained.
[F7Processed animal protein obtained from farmed insects may be imported into the Union provided that it has been produced in compliance with the following conditions:
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 ( Alphitobius diaperinus ),
House cricket ( Acheta domesticus ), Banded cricket ( Gryllodes sigillatus ) and Field Cricket ( Gryllus assimilis );
the substrate for the feeding of insects may only contain products of non-animal origin or the following products of animal origin of Category 3 material:
fishmeal,
blood products from non-ruminants,
di and tricalcium phosphate of animal origin,
hydrolysed proteins from non-ruminants,
hydrolysed proteins from hides and skins of ruminants,
gelatine and collagen from non-ruminants,
eggs and egg products,
milk, milk based-products, milk-derived products and colostrum,
honey,
rendered fats;
the substrate for the feeding of insects and the insects or their larvae have not been in contact with any other materials of animal origin than those mentioned in point (b) and the substrate did not contain manure, catering waste or other waste.]
Textual Amendments
F7 Inserted by Commission Regulation (EU) 2017/893 of 24 May 2017 amending Annexes I and IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annexes X, XIV and XV to Commission Regulation (EU) No 142/2011 as regards the provisions on processed animal protein (Text with EEA relevance).
Textual Amendments
F6 Substituted by Commission Regulation (EU) No 749/2011 of 29 July 2011 amending Regulation (EU) No 142/2011 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 (Text with EEA relevance).
The following requirements shall apply to the importation of rendered fats:
Rendered fat shall:
be entirely or partly derived from porcine raw material and come from a third country or a part of the territory of a third country free from foot-and-mouth disease for the previous 24 months and free from classical swine fever and African swine fever for the previous 12 months;
be entirely or partly derived from poultry raw material and come from a third country or a part of the territory of a third country free from Newcastle disease and avian influenza for the previous six months;
be entirely or partly derived from ruminant raw material and come from a third country or a part of the territory of a third country free from foot-and-mouth disease for the previous 24 months and free from rinderpest for the previous 12 months; or
where there has been an outbreak of one of the diseases referred to in points (a), (b) and (c) during the relevant period referred to in those points, have been subjected to one of the following heat treatments:
at least 70 °C for at least 30 minutes; or
at least 90 °C for at least 15 minutes.
Details of the critical control points shall be recorded by operators and maintained so that the owner, operator or their representative and, as necessary, the competent authority can monitor the operation of the plant; and the recorded information shall include the particle size, critical temperature and, as appropriate, the absolute time, pressure profile, raw material feed rate and fat recycling rate.
Milk, milk-based products and milk-derived products shall:
have undergone at least one of the treatments provided for in points 1.1, 1.2, 1.3 and point (a) of point B.1.4 of Part I of Section 4 of Chapter II of Annex X;
comply with points B.2 and B.4, and, in the case of whey, point B.3 of Part I of Section 4 of Chapter II of Annex X.
By way of derogation from point B.1.4 of Part I of Section 4 of Chapter II of Annex X, milk, milk-based products and milk-derived products may be imported from third countries so authorised in column ‘A’ of Annex I to Regulation (EU) No 605/2010, provided that the milk, milk-based products or milk-derived products have undergone a single HTST treatment and:
have not been shipped before a period of at least 21 days has elapsed after production and during that period no case of foot-and-mouth disease has been detected in the exporting third country; or
have been presented at a border inspection post of entry into the Union at least 21 days after production and during that period no case of foot-and-mouth disease has been detected in the exporting third country.
The materials shall have undergone a single HTST treatment and:
have not been shipped before a period of at least 21 days has elapsed after production and during that period no case of foot-and-mouth disease has been detected in the exporting third country; or
have been presented at a border inspection post of entry into the Union at least 21 days after production and during that period no case of foot-and-mouth disease has been detected in the exporting third country.
The materials shall have been obtained from bovine animals subject to regular veterinary inspections to ensure that they come from holdings on which all bovine herds are:
either recognised as officially tuberculosis-free and officially brucellosis-free as defined in Article 2(2)(d) and (f) of Directive 64/432/EEC or not restricted under the national legislation of the third country of origin of the colostrum regarding eradication of tuberculosis and brucellosis; and
either recognised as official enzootic-bovine-leukosis-free as defined in Article 2(2)(j) of Directive 64/432/EEC or included in an official system for the control of enzootic bovine leukosis and there has been no evidence as a result of clinical and laboratory testing of this disease in the herd during the past two years.
After completion of the processing, every precaution shall have been taken to prevent contamination of the colostrum or colostrum products.
The final product must bear a label so as to indicate that it contains Category 3 material and is not intended for human consumption, and it must have been:
packed in new containers; or
transported in bulk in containers or other means of transport that before use were thoroughly cleaned and disinfected.
The following requirements shall apply to the importation of blood products, including spray dried blood and blood plasma which have been derived from porcine animals intended for the feeding of porcine animals:
These derived products must be:
subjected to a heat treatment at a temperature of at least 80 °C throughout the substance and the dry blood and blood plasma is of not more than 8 % moisture with a water activity (Aw) of less than 0,60;
stored in dry warehouse conditions under room temperature for at least 6 weeks.]
Textual Amendments
F8 Inserted by Commission Regulation (EU) 2015/9 of 6 January 2015 amending Regulation (EU) No 142/2011 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 (Text with EEA relevance).
As referred to in Article 41(1)(a) and (2)(c) and Article 41(3) of Regulation (EC) No 1069/2009, the following specific requirements shall apply to imported consignments of animal by-products and derived products for uses outside the feed chain for farmed animals and consignments of such products in transit:
they must consist of or have been produced from animal by-products referred to in the column ‘raw materials’ of Table 2;
they must comply with the import and transit conditions set out in the column ‘import and transit conditions’ of Table 2;
[F1they must come from a third country or part of a third country listed in the column ‘ third countries’ list ’ of Table 2;
they must come from an establishment or plant which is registered or approved by the competent authority of the third country, as applicable, and which is on the list of such establishments and plants referred to in Article 30; and
they must be:
accompanied during transportation to the point of entry into the Union where the veterinary checks take place by the health certificate referred to in the column ‘ certificates/model documents ’ of Table 2; or
presented at the point of entry into the Union where the veterinary checks take place accompanied by a document corresponding to the model referred to in the column ‘ certificates/model documents ’ of Table 2.]
[F2. . . . .]
No | Product | Raw materials (reference to provisions of Regulation (EC) No 1069/2009) | Import and transit conditions | Third countries’ lists | Certificates/model documents |
---|---|---|---|---|---|
1 | Processed manure, derived products from processed manure and guano from bats | Category 2 material referred to in Article 9(a). | The processed manure, the derived products from processed manure and the guano from bats must have been produced in accordance with Section 2 of Chapter I of Annex XI. | Third countries listed in: (a) Part 1 of Annex II to Regulation (EU) No 206/2010; (b) Annex I to Decision 2004/211/EC; or (c) Part 1 of Annex I to Regulation (EC) No 798/2008. | Annex XV, Chapter 17. |
2 | Blood products, еxcluding from equidae, for the manufacture of derived products for uses outside the feed chain for farmed animals | Category 1 material referred to in Article 8(c) and (d) and Category 3 material referred to in Article 10(a), (b), (d) and (h). | The blood products must have been produced in accordance with Section 2. | The following third countries: (a) in the case of untreated blood products of ungulates: Third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 from which imports of fresh meat of any domestic ungulate species is authorised and only for the period indicated in column 7 and 8 of that Part. Japan. (b) in the case of untreated blood products of poultry and other avian species: Third countries or parts of third countries listed in Part 1 of Annex I to Regulation (EC) No 798/2008. Japan. (c) in the case of untreated blood products of other animals: Third countries listed either in Part 1 of Annex II to Regulation (EU) No 206/2010, in Part 1 of Annex I to Regulation (EC) No 798/2008, or in Part 1 of Annex I to Regulation (EC) No 119/2009. Japan. (d) in the case of treated blood products of any species: Third countries listed in Part 1 to Annex II of Regulation (EU) No 206/2010, in Part 1 of Annex I to Regulation (EC) No 798/2008 or in Part 1 of Annex I to Regulation (EC) No 119/2009. Japan. | (a)In the case of untreated blood products:Annex XV, Chapter 4 (C). (b)In the case of treated blood products:Annex XV, Chapter 4 (D). |
3 | Blood and blood products from equidae | Category 3 materials referred to in Article 10(a), (b), (d) and (h). | The blood and the blood products shall comply with the requirements set out in Section 3. | The following third countries: (a) in the case of blood that has been collected in accordance with point 1 of Chapter IV of Annex XIII or where blood products have been produced in accordance with point 2(b)(i) of that Chapter: Third countries or parts of third countries listed in Annex I to Decision 2004/211/EC, from which the importation of equidae for breeding and production is allowed. (b) in the case of blood products which have been treated in accordance with point 2(b)(ii) of Chapter IV of Annex XIII: Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which Member States authorise imports of fresh meat of domestic equidae. | Annex XV, Chapter 4(A). |
4 | Fresh or chilled hides and skins of ungulates | Category 3 materials referred to in Article 10 (a) and (b)(iii). | The hides and skins shall comply with the requirements set out in Section 4, points 1 and 4. | The hides and skins come from a third country, or, in the case of regionalisation in accordance with Union legislation, a part of a third country listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which Member States authorise imports of fresh meat from the same species. | Annex XV, Chapter 5(A). |
5 | Treated hides and skins of ungulates | Category 3 materials referred to in Article 10 (a), (b)(i) and (iii) and (n). | The hides and skins shall comply with the requirements set out in Section 4, points 2, 3 and 4. | (a)In the case of treated hides and skins of ungulates:Third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010. (b)In the case of treated hides and skins of ruminants that are intended for dispatch to the European Union and which have been kept separate for 21 days or will undergo transport for 21 uninterrupted days before importation:Any third country. | (a)In the case of treated hides and skins of ungulates, other than those which comply with the requirements set out in Section 4, point 2:Annex XV, Chapter 5(B). (b)In the case of treated hides and skins of ruminants and of equidae that are intended for dispatch to the European Union and which have been kept separate for 21 days or will undergo transport for 21 uninterrupted days before importation:The official declaration set out in Annex XV, Chapter 5(C). (c)In the case of treated hides and skins of ungulates which comply with the requirements set out in Section 4, point 2:No certificate is required. |
6 | Game trophies and other preparations from animals | Category 2 materials referred to in Article 9, point (f) derived from wild animals not suspected of being infected with a disease communicable to humans or animals and Category 3 material referred to in Article 10(a), (b)(i), (iii) and (v) and (n). | The game trophies and other preparations shall comply with the requirements set out in Section 5. | (a)In the case of game trophies and other preparations referred to in Section 5, point 2:Any third country. (b)In the case of game trophies and other preparations referred to in Section 5, point 3:(i) Game trophies from birds: Third countries listed in Part 1 of Annex I to Regulation (EC) No 798/2008, from which the Member States authorise imports of fresh poultrymeat, and the following countries:
(ii) Game trophies from ungulates: Third countries listed in the appropriate columns for fresh meat of ungulates in Part 1 of Annex II to Regulation (EU) No 206/2010, including any restrictions laid down in the column for special remarks for fresh meat. | (a)In the case of game trophies referred to in Section 5, point 2:Annex XV, Chapter 6(A). (b)In the case of game trophies referred to in Section 5, point 3:Annex XV, Chapter 6(B). (c)In the case of game trophies referred to in Section 5, point 1:No certificate is required. |
7 | Pig bristles | Category 3 materials referred to in Article 10 (b)(iv). | The pig bristles must have been obtained from animals originating, and slaughtered in a slaughterhouse, in the third country of origin. | (a)In the case of untreated pig bristles:Third countries, or, in the case of regionalisation, regions thereof, listed in part 1 of Annex II to Regulation (EU) No 206/2010, which are free of African swine fever for the 12 months prior to the date of importation. (b)In the case of treated pig bristles:Third countries listed in part 1 of Annex II to Regulation (EU) No 206/2010, which may not be free of African swine fever for the last 12 months prior to the date of importation. | (a)If no case of African swine fever has occurred during the 12 previous months:Annex XV, Chapter 7(A). (b)In case one or more cases of African swine fever have occurred during the previous 12 months:Annex XV, Chapter 7(B). |
[F98 | Untreated wool and hair produced from animals other than those of the porcine species | Category 3 materials referred to in Article 10(h) and (n). | (1) The dry untreated wool and hair must be(a) securely enclosed in packaging; and (b) sent directly to a plant producing derived products for uses outside the feed chain or a plant carrying out intermediate operations, under conditions which prevent the spreading of pathogenic agents. | (1) Any third country. | (1) For imports of untreated wool and hair, no health certificate is required. |
(2) The wool and hair are wool and hair as referred to in Article 25(2)(e). | (2) Third country or region thereof(a) listed in Part 1 of Annex II to Regulation (EU) No 206/2010 and authorised for imports into the Union of fresh meat of ruminants not subject to supplementary guarantees A and F mentioned therein; and (b) free of foot-and-mouth disease and, in case of wool and hair of sheep and goats, of sheep pox and goat pox in accordance with Annex II to Council Directive 2004/68/EC. | (2) A declaration of the importer in accordance with Chapter 21 of Annex XV is required.] | |||
9 | Treated feathers, parts of feathers and down | Category 3 materials referred to in Article 10 (b)(v) and (h) and (n). | The treated feathers or parts of feathers shall comply with the requirements set out in Section 6. | Any third country. | For imports of treated feathers, parts of feathers and down, no health certificate is required. |
10 | Apiculture by-products | Category 3 materials referred to in Article 10 (e). | (a)In the case of apiculture by-products intended for use in apiculture, other than beeswax in the form of honeycomb:(i) The apiculture by-products have been subjected to a temperature of – 12 °C or lower temperature for at least 24 hours; or (ii) In the case of beeswax, the material has been processed in accordance with any of the processing methods 1 to 5 or processing method 7, as set out in Chapter III of Annex IV, and refined before importation. (b)In the case of beeswax, other than beeswax in the form of honeycomb, for purposes other than feeding to farmed animals, the beeswax has been refined or processed in accordance with any of the processing methods 1 to 5 or processing method 7, as set out in Chapter III of Annex IV before importation. | (a)In the case of apiculture by-products intended for use in apiculture:Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, and the following country: (CM) Cameroon. (b)In the case of beeswax for purposes other than feeding to farmed animals:Any third country. | (a)In the case of apiculture by-products intended for use in apiculture:Annex XV, Chapter 13. (b)In the case of beeswax for purposes other than feeding to farmed animals:A commercial document attesting the refinement or processing. |
11 | Bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) for uses other than as feed material, organic fertiliser or soil improver | Category 3 materials referred to in Article 10(a) (b)(i) and (iii), (e) and (h). | The products shall comply with the requirements set out in Section 7. | Any third country. | The products shall be accompanied by: (a) a commercial document as et out in Section 7, point 2; and (b) a declaration of the importer in accordance with Annex XV, Chapter 16 in at least one official language of the Member State through which the consignment first enters the Union and in at least one official language of the Member State of destination. |
[F1012 | Petfood, including dogchews | (a) In the case of processed petfood and of dogchews: materials referred to in Article 35(a)(i) and (ii). (b) In the case of raw petfood: materials referred to in Article 35(a)(iii). | The petfood and the dogchews must have been produced in accordance with Chapter II of Annex XIII. | (a) In the case of raw petfood: Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 or in Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh meat from the same species and where only bone-in meat is authorised. In the case of fish materials, third countries listed in Annex II to Decision 2006/766/EC. (b) In the case of dogchews and petfood other than raw petfood:
| (a) In the case of canned petfood: Annex XV, Chapter 3(A). (b) In the case of processed petfood other than canned petfood: Annex XV, Chapter 3(B). (c) In the case of dogchews: Annex XV, Chapter 3(C). (d) In the case of raw petfood: Annex XV, Chapter 3(D).] |
[F513 | Flavouring innards for the manufacture of petfood | Materials referred to in Article 35(a) | The flavouring innards must have been produced in accordance with Chapter III of Annex XIII. | Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which Member States authorise imports of fresh meat from the same species and where only bone-in meat is authorised. In the case of flavouring innards from fish materials, third countries listed in Annex II to Decision 2006/766/EC. In the case of flavouring innards of poultry origin, third countries listed in Part 1 of Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh poultry meat. In the case of flavouring innards from certain wild land mammals and leporidae, third countries listed in Part 1 of Annex I to Regulation (EC) No 119/2009 from which Member States authorise imports of fresh meat from the same species. | Annex XV, Chapter 3(E).] |
14 | Animal by-products for the manufacture of petfood other than raw petfood and of derived products for uses outside the feed chain | [F1(a) Category 3 materials referred to in Article 10(a) to (m).](b)In the case of materials for the manufacture of petfood, Category 1 materials referred to in Article 8(c).(c)In the case of fur for the manufacture of derived products, Category 3 materials referred to in Article 10(n). | The products shall comply with the requirements set out in Section 8. | (a)In the case of animal by-products for the manufacture of petfood:(i) In the case of animal by-products from bovine, ovine, caprine, porcine and equine animals, including farmed and wild animals: Third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which imports of fresh meat for human consumption is authorised. (ii) Raw material from poultry including ratites: Third countries or parts of third countries from which Member States authorise imports of fresh poultrymeat, which are listed in Part 1 of Annex I to Regulation (EC) No 798/2008. (iii) Raw material from fish: Third countries listed in Annex II to Decision 2006/766/EC. (iv) Raw material from other wild land mammals and leporidae: Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 or in Part 1 of Annex I to Regulation (EC) No 798/2008. (b)In the case of animal by-products for the manufacture of pharmaceuticals:Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, in Part 1 of Annex I to Regulation (EC) No 798/2008 or in Part 1 of Annex I to Regulation (EC) No 119/2009, and the following third countries:
(c)In the case of animal by-products for the manufacture of products for uses outside the feed chain for farmed animals, other than pharmaceuticals:Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 from which imports of fresh meat of the respective species is authorised, in Part 1 of Annex I to Regulation (EC) No 798/2008, in Part 1 of Annex I to Regulation (EC) No 119/2009, or, in the case of material from fish, third countries listed in Annex II to Decision 2006/766/EC. | (a)In the case of animal by-products for the manufacture of processed petfood:Annex XV, Chapter 3(F). (b)In the case of animal by-products for the manufacture of products for uses outside the feed chain for farmed animals:Annex XV, Chapter 8. |
[F115 | Animal by-products for use as raw petfood | Category 3 materials referred to in Article 10(a) and Article 10(b)(i) and (ii). | The products shall comply with the requirements set out in Section 8. | Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 or in Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh meat from the same species and where only bone in meat is authorised. In the case of fish materials, third countries listed in Annex II to Decision 2006/766/EC. | Annex XV, Chapter 3(D). |
16 | Animal by-products for use in feed for fur animals | Category 3 materials referred to in Article 10(a) to (m) | The products shall comply with the requirements set out in Section 8. | Third countries listed in part 1 of Annex II to Commission Regulation (EU) No 206/2010, or in Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh meat from the same species and where only bone in meat is authorised. In the case of fish materials, third countries listed in Annex II to Decision 2006/766/EC. | Annex XV, Chapter 3(D).] |
[F517 | Rendered fats for certain purposes outside the feed chain for farmed animals | (a) In the case of materials destined for the production of biodiesel, oleochemical products or renewable fuels referred to in point L of Section 2 of Chapter IV of Annex IV: Categories 1, 2 and 3 materials referred to in Articles 8, 9 and 10.(b) In the case of materials destined to the production of renewable fuels referred to in point J of Section 2 of Chapter IV of Annex IV: Category 2 and 3 materials referred to in Articles 9 and 10.(c) In the case of materials destined to organic fertilisers and soil improvers:Category 2 materials referred to in Article 9, points (c), (d) and (f)(i) and Category 3 materials referred to in Article 10, other than in points (c) and (p). (d) In the case of materials destined to other purposes:Category 1 materials referred to in Article 8, points (b), (c) and (d), Category 2 materials referred to in Article 9, points (c), (d) and (f)(i) and Category 3 materials referred to in Article 10, other than in points (c) and (p). | The rendered fats shall comply with the requirements set out in Section 9. | Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 and, in the case of fish materials, third countries listed in Annex II to Decision 2006/766/EC. | Chapter 10(B) of Annex XV.] |
[F118 | Fat derivatives | (a) In the case of fat derivatives for uses outside the feed chain for farmed animals: Category 1 materials referred to in Article 8(b), (c) and (d), Category 2 materials referred to in Article 9(c) and (d) and Article 9(f)(i) and Category 3 materials referred to in Article 10. (b) In the case of fat derivatives for use as feed: Category 3 materials other than materials referred to in Article 10(n), (o) and (p); | The fat derivatives shall comply with the requirements set out in Section 10. | Any third country. | (a) In the case of fat derivatives for uses outside the feed chain for farmed animals: Annex XV, Chapter 14(A). (b) In the case of fat derivatives for use as feed: Annex XV, Chapter 14(B).] |
19 | Photogelatine | Category 1 materials referred to in Article 8(b) and Category 3 materials referred to in Article 10. | The imported photogelatine shall comply with the requirements set out in Section 11. | Photogelatine may only be imported from establishments of origin in the United States and in Japan that are authorised in accordance with Section 11. | Annex XV, Chapter 19. |
20 | Horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, for the production of organic fertilisers or soil improvers | Category 3 materials referred to in Article 10(a), (b), (h) and (n). | The products shall comply with the requirements set out in Section 12. | Any third country. | Annex XV, Chapter 18. |
Textual Amendments
F9 Substituted by Commission Regulation (EU) No 1063/2012 of 13 November 2012 amending Regulation (EU) No 142/2011 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 (Text with EEA relevance).
The following requirements shall apply to the import of blood and blood products, excluding those from equidae, for the manufacture of derived products for uses outside the feed chain for farmed animals:
The blood products must originate from a plant for the production of derived products for uses outside the feed chain for farmed animals which meets the specific conditions laid down in this Regulation or from the establishment of collection.
[F1The blood from which blood products for the manufacture of derived products for uses outside the feed chain for farmed animals are produced must have been collected under veterinary supervision:
in slaughterhouses:
approved in accordance with Regulation (EC) No 853/2004; or
approved and supervised by the competent authority of the country of collection; or
from live animals in facilities approved and supervised by the competent authority of the country of collection.]
In the case of blood products for the manufacture of derived products for uses outside the feed chain for farmed animals which have been derived from animals belonging to the taxa Artiodactyla, Perissodactyla and Proboscidea, including their crossbreeds, they must comply with the conditions of either point (a) or (b):
the products must have undergone one of the following treatments guaranteeing the absence of pathogens of the diseases referred to in point (b):
heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;
irradiation at 25 kGy by gamma rays, followed by an effectiveness check;
heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check;
in the case of animals other than Suidae and Tayassuidae only: change in pH to pH 5 for two hours, followed by an effectiveness check;
in the case of blood products not treated in accordance with point (a) the products must originate from a third country or region:
where no case of rinderpest, peste des petits ruminants and Rift Valley fever has been recorded for a period of at least 12 months and in which vaccination has not been carried out against those diseases for a period of at least 12 months;
where no case of foot-and-mouth disease has been recorded for a period of at least 12 months, and,
in which vaccination has not been carried out against this disease for a period of at least 12 months, or
in which vaccination programmes against foot-and-mouth disease are being officially carried out and controlled in domestic ruminant animals for a period of at least 12 months; in this case, following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the registered establishment or plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.
In addition to point (b)(i) and (ii) of point 3.1, in the case of animals other than Suidae and Tayassuidae, one of the following conditions must be complied with:
in the third country or region of origin no case of vesicular stomatitis and bluetongue (including the presence of seropositive animals) has been recorded for a period of at least 12 months and vaccination has not been carried out against those diseases for a period of at least 12 months in the susceptible species;
following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.
In addition to point (b)(i) and (ii) of point 3.1, in the case of Suidae and Tayassuidae, in the third country or region of origin no case of swine vesicular disease, classical swine fever and African swine fever has been recorded for a period of at least 12 months, vaccination has not been carried out against those diseases for a period of at least 12 months and one of the following conditions are complied with:
in the country or region of origin no case of vesicular stomatitis (including the presence of seropositive animals) has been recorded for a period of 12 months and vaccination has not been carried out against this disease for a period of at least 12 months in the susceptible species;
following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the registered establishment or plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.
In the case of blood products for the manufacture of derived products for uses outside the feed chain for farmed animals which have been derived from poultry and other avian species, they must comply with the following conditions of either point (a) or (b):
the products must have undergone one of the following treatments guaranteeing the absence of pathogens of the diseases referred to in point (b):
heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;
irradiation at 25 kGy by gamma rays, followed by an effectiveness check;
heat treatment of at least 70 °C throughout their substance, followed by an effectiveness check;
in case of blood products not treated in accordance with point (a) the products must originate from a third country or region:
which has been free from Newcastle disease and highly pathogenic avian influenza as listed in the Terrestrial Animal Health Code of the OIE, 2010 edition;
which during the last 12 months has not carried out vaccination against avian influenza;
where the poultry or other avian species from which the products derive have not been vaccinated against Newcastle disease with vaccines prepared from a Newcastle disease master strain showing a higher pathogenicity than lentogenic virus strains.
The following requirements shall apply to the import of blood and blood products from equidae:
[F1The blood must comply with the conditions set out in point 1(a) of Chapter IV of Annex XIII and must be collected under veterinary supervision:
in slaughterhouses:
approved in accordance with Regulation (EC) No 853/2004; or
approved and supervised by the competent authority of the country of collection; or
from live equidae in facilities approved and furnished with a veterinary approval number and supervised by the competent authority of the country of collection for the purpose of collecting blood from equidae for the production of blood products for purposes other than feeding.]
The blood products must comply with the conditions set out in point 2 of Chapter IV of Annex XIII.
In addition, the blood products referred to in point 2(b)(i) of Chapter IV of Annex XIII must be produced from blood collected from equidae which have been kept for a period of at least three months, or since birth if less than three months old, prior to the date of collection on holdings under veterinary supervision in the third country of collection which during that period and the period of blood collection has been free of:
African horse sickness in accordance with points (a) and (b) of the first subparagraph of Article 5(2) of Directive 2009/156/EC;
Venezuelan equine encephalomyelitis for a period of at least two years;
glanders:
for a period of three years; or
for a period of six months where the animals have shown no clinical signs of glanders (Burkholderia mallei) during the post-mortem inspection in the slaughterhouse referred to in point 1(a), including a careful examination of mucous membranes from the trachea, larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising the nasal septum;
[F1in the case of blood products other than serum and plasma, vesicular stomatitis for a period of at least six months.]
Blood products must come from an establishment or plant which has been approved or registered by the competent authority of the third country.
Blood and blood products shall be packed and labelled in accordance with point 3 of Chapter IV of Annex XIII.
The following requirements shall apply to the import of hides and skins of ungulates:
Fresh or chilled hides and skins may be imported if:
they come from a third country referred to in the applicable column of row 4 of Table 2 set out in Section 1 which, as appropriate to the species concerned:
for a period of at least 12 months before dispatch, has been free from all of the following diseases:
classical swine fever,
African swine fever, and
Rinderpest; and
has been free from foot-and-mouth disease for a period of at least 12 months before the date of dispatch and where, for a period of at least 12 months before the date of dispatch, no vaccination has been carried out against that disease;
they have been obtained from:
animals that have remained in the territory of the third country of origin for a period of at least three months before being slaughtered or since birth in the case of animals less that three months old;
in the case of hides and skins from bi-ungulates, animals that come from holdings in which there has been no outbreak of foot-and mouth disease in the previous 30 days, and around which within a radius of 10 km there has been no case of foot-and-mouth disease for 30 days;
in the case of hides and skins from swine, animals that come from holdings in which there has been no outbreak of swine vesicular disease in the previous 30 days, or of classical or African swine fever in the previous 40 days, and around which within a radius of 10 km there has been no case of these diseases for 30 days; or
animals that have passed the ante-mortem health inspection at the slaughterhouse during the 24 hours before slaughter and have shown no evidence of foot-and-mouth disease, rinderpest, classical swine fever, African swine fever or swine vesicular disease; and
they have undergone all precautions to avoid recontamination with pathogenic agents.
Treated hides and skins referred to in point C.2 of Chapter V of Annex XIII may be imported without any restrictions.
Other treated hides and skins may be imported if:
they come either from:
a third country or, in the case of regionalisation in accordance with Union legislation, from a part of a third country, appearing on the list set out in point (a) of the column ‘third countries’ list’ of row 5 of Table 2 set out in Section 1 from which imports of fresh meat of the corresponding species are authorised and they have been treated as referred to in point 28(a), (b) and (c) of Annex I;
a third country appearing on the list set out in point (a) of the applicable column of row 5 of Table 2 set out in Section 1 and they have been treated as referred to in point 28(c) or (d) of Annex I; or
equidae or ruminant animals from a third country appearing on the list set out in point (b) of the column ‘third countries’ list’ of row 5 of Table 2 of Section 1, and have been treated as referred to in point 28(a), (b) and (c) of Annex I and after treatment have been kept separate for a period of at least 21 days; and
in the case of salted hides and skins transported by ship, they have been treated as referred to in point 28(b) or (c) of Annex I and have been kept separated after treatment during transportation for a period of at least 14 days in the case of the treatment referred to in point 28(b) or seven days in the case of the treatment referred to in point 28(c) before importation and the health certificate accompanying the consignment attests such treatment and the duration of the transportation.
Fresh, chilled or treated hides and skins of ungulates must be imported in containers, road vehicles, railway wagons or bales sealed under the responsibility of the competent authority of the third country of dispatch.
The following requirements shall apply to the import of game trophies and other preparations from animals:
Game trophies or other preparations from animals which fulfil the conditions referred to in points B and C.1 of Chapter VI of Annex XIII may be imported without restrictions.
Treated game trophies or other preparations from birds and ungulates, being solely comprised of bones, horns, hooves, claws, antlers, teeth, hides or skins, from third countries may be imported if they comply with the requirements of point C.1(a) and point C.2(a), (i) to (iii) and (b)(i) and (ii) of Chapter VI of Annex XIII.
However, in the case of dry-salted or wet-salted skins transported by ship, the skins need not be salted 14 days before dispatch, provided that they are salted for 14 days before importation.
Game trophies or other preparations from birds and ungulates consisting of entire anatomical parts, not having been treated in any way may be imported if:
they come from animals originating in an area not subject to restrictions as a result of the presence of serious transmissible diseases to which animals of the species concerned are susceptible;
they were packaged without being in contact with other products of animal origin likely to contaminate them, in individual, transparent and closed packages so as to avoid any subsequent contamination.
Treated feathers and parts of feathers and down may be imported:
if they are treated decorative feathers, treated feathers carried by travellers for their private use or consignments of treated feathers or down sent to private individuals for non-industrial purposes; or
if they are accompanied by a commercial document stating that the feathers and parts of feathers or down have been treated with a steam current or by another method that ensures that no unacceptable risks remain and are securely enclosed in packaging and dry; and
unless the commercial document states that they have been factory-washed and treated with hot steam at 100 °C for at least 30 minutes, they are sent to a registered establishment or plant for such treatment.
the products are dried before export to the Union and not chilled or frozen;
[F4the products are conveyed from the third country of origin directly to a border inspection post of entry into the Union and are not transhipped at any port or place outside the Union;]
following the document checks provided for in Directive 97/78/EC, the products are conveyed directly to the registered establishment or plant of destination.
the third country of origin;
the name of the establishment or plant of production;
the nature of the product (dried bone/dried bone product/dried horns/dried horn products/dried hooves/dried hoof products), and
[F11confirmation that the product is not intended at any stage to be diverted for any use in the manufacturing of food, feed material, organic fertilisers or soil improvers, and
was derived from healthy animals slaughtered in a slaughterhouse; and
either was dried for a period of 42 days at an average temperature of at least 20 °C; and/or
was heated for one hour to a temperature of at least 80 °C to the core; and/or
was incinerated to ash for one hour at a temperature of at least 800 °C to the core; and/or
underwent an acidification process such that the pH was maintained for at least one hour at less than 6 to the core.]
Textual Amendments
F11 Substituted by Commission Regulation (EU) 2020/762 of 9 June 2020 amending Regulation (EU) No 142/2011 as regards microbiological standards for raw petfood, requirements concerning approved establishments, technical parameters applicable to the alternative method Brookes’ gasification process and hydrolysis of rendered fats, and exports of processed manure, certain blood, blood products and intermediate products (Text with EEA relevance).
If transported in containers, the containers, and in all cases all the accompanying documents, must bear the name and the address of the registered establishment or plant of destination.
Animal by-products intended for the manufacture of feed for fur animals, petfood, other than raw petfood, and for derived products for uses outside the feed chain for farmed animals may be imported provided that:
the animal by-products have been deep-frozen at the plant of origin or have been preserved in accordance with Union legislation in such a way to prevent spoiling between dispatch and delivery to the establishment or plant of destination;
the animal by-products have undergone all precautions to avoid contamination with pathogenic agents;
the animal by-products were packed in new packaging preventing any leakage or in packaging which has been cleaned and disinfected before use;
following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the animal by-products are transported directly either to:
a petfood plant or to a registered establishment or plant of destination, which has provided a guarantee that the animal by-products shall be used only for the purpose of producing the products for which it has been registered or approved, as applicable, as specified by the competent authority if necessary, and shall not leave the establishment or plant untreated other than for direct disposal;
an establishment or plant which has been approved in accordance with Article 24(1)(h) of Regulation (EC) No 1069/2009;
a registered user or collection centre, which has provided a guarantee that the animal by-products shall be used only for permitted purposes, as specified by the competent authority if necessary; or
an establishment or plant which has been approved in accordance with Article 24(1)(a) of Regulation (EC) No 1069/2009; and
in the case of raw material for petfood production referred to in Article 35(a)(ii) of Regulation (EC) No 1069/2009, the raw material shall:
be marked in the third country before entry into the Union by a cross of liquefied charcoal or activated carbon, on each outer side of each frozen block, or, when the raw material is transported in pallets which are not divided into separate consignments during transport to the petfood plant of destination, on each outer side of each pallet, in such a way that the marking covers at least 70 % of the diagonal length of the side of the frozen block and is at least 10 cm in width;
in the case of material which is not frozen, be marked in the third country before entry into the Union by spraying it with liquefied charcoal or by applying charcoal powder in such a way that the charcoal is clearly visible on the material;
be transported directly to:
the petfood plant of destination in accordance with point 4(a); or
an establishment or plant of destination which has been approved in accordance with Article 24(1)(h) of Regulation (EC) No 1069/2009, in accordance with point 4(b) of this Section and from there directly to the petfood plant referred to under (i), provided that the plant of destination:
only handles material covered by this point 5.1, or
only handles material destined for a petfood plant as referred to under (i); and
be manipulated to remove the marking provided for in points (a) and (b) only in the petfood plant of destination and only immediately prior to use of the material for the manufacture of petfood, in accordance with the conditions applicable to petfood produced from Category 3 material set out in Chapter II of Annex XIII;
in the case of consignments made up of raw material, which has been treated as referred to in point 5.1 above and other non-treated raw material, all the raw materials in the consignment have been marked as laid down in point 5.1(a) and (b) above;
the marking referred to in point 5.1(a) and (b) and point 5.2 remains visible from the dispatch and until the delivery to the petfood plant of destination;
In the petfood plant of destination, raw material for petfood production referred to in Article 35(a)(ii) of Regulation (EC) No 1069/2009 shall be stored before production, used and disposed of under conditions authorised by the competent authority, which allow official controls on the amounts of material received, used for production and disposed of, if applicable.
The competent authority may authorise the operator of the petfood plant to store such materials together with Category 3 material.
Rendered fats which are not destined to the production of feed for farmed animals, the manufacture of cosmetics, medicinal products or medical devices, may be imported, provided:
they are derived from:
[F11in the case of materials destined for the production of biodiesel, oleochemical products or for the production of renewable fuels which have undergone the treatment referred to in point L of Section 2 of Chapter IV of Annex IV, animal by-products referred to in Articles 8, 9 and 10 of Regulation (EC) No 1069/2009;]
in the case of materials destined to the production of organic fertilisers and soil improvers, Category 2 materials referred to in points (c), (d) and (f)(i) of Article 9 of Regulation (EC) No 1069/2009, or Category 3 materials, other than materials referred to in points (c) and (p) of Article 10 of Regulation (EC) No 1069/2009;
[F6in the case of materials destined to the production of renewable fuels referred to in point J of Section 2 of Chapter IV of Annex IV of this Regulation, Category 2 materials referred to in Article 9 of Regulation (EC) No 1069/2009 and Category 3 materials referred to in Article 10 of that Regulation;
in the case of other materials Category 1 materials referred to in points (b), (c) and (d) of Article 8 of Regulation (EC) No 1069/2009, Category 2 materials referred to in points (c) and (d) and point (f)(i) of Article 9 of Regulation (EC) No 1069/2009 or Category 3 materials, other than the materials referred to in points (c) and (p) of Article 10 of that Regulation;]
they have been processed by processing method 1 (pressure sterilisation) or in accordance with one of the other processing methods referred to in Chapter III of Annex IV;
in the case of fat from ruminant origin, insoluble impurities in excess of 0,15 % by weight have been removed;
they have been marked before shipment to the Union so that the minimum concentration of GTH referred to in point 1(b) of Chapter V of Annex VIII is achieved;
following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the rendered fats are transported directly to the registered establishment or plant of destination, under conditions which prevent contamination; and
they bear labels, on the packaging or container indicating ‘NOT FOR HUMAN OR ANIMAL CONSUMPTION’.
whether the fat derivatives derive from Category 1, 2 or 3 materials;
in the case of fat derivatives produced from Category 2 material, that the products:
have been produced using a method that at least meets the standards of one of the processes referred to in point 1 of Chapter XI of Annex XIII; and
shall only be used in organic fertiliser or soil improvers or other uses outside the feed chain for farmed animals, other than in cosmetics, pharmaceuticals and medical devices;
in the case of fat derivatives produced from Category 1 material, that the products must not be used in organic fertilisers and soil improvers, cosmetics, pharmaceuticals and medical devices; however, they may be used for other purposes outside the feed chain for farmed animals.
originates from one of the plants of origin indicated in Table 3;
has been produced in accordance with point 6;
is imported through one of the border inspection posts of first entry into the Union indicated in Table 3; and
is destined for production in an approved photographic factory indicated in 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 418-0073 Japan | The Netherlands | Rotterdam | FujifilmEurope, Oudenstaart 1, 5047 TK Tilburg, The Netherlands |
Nitta Gelatin Inc., 2-22 Futamata Yao-City, Osaka 581-0024 Japan | United Kingdom | Liverpool Felixstowe Heathrow | Kodak Ltd. Headstone Drive, Harrow, Middlesex, HA4 4TY, United Kingdom | |
Czech Republic | Hamburg | FOMA Bohemia, spol. SRO Jana Krušinky 1604 501 04 Hradec Králove, Czech Republic | ||
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 | United Kingdom | Liverpool Felixstowe Heathrow | Kodak Ltd. Headstone Drive, Harrow, Middlesex, HA4 4TY, United Kingdom |
Czech Republic | Hamburg | FOMA Bohemia spol. SRO Jana Krušinky 1604 501 04 Hradec Králove, Czech Republic |
transported in sealed leak-proof containers labelled ‘for disposal only’ in vehicles under satisfactory hygiene conditions;
disposed of in accordance with Article 12(a)(i) of Regulation (EC) No 1069/2009 or exported to the third country of origin in accordance with Regulation (EC) No 1013/2006.
Photogelatine shall only be produced in plants which do not produce gelatine for food or feed intended for dispatch to the European Union, and which are approved by the competent authority of the third country concerned.
Photogelatine shall be produced by a process that ensures that raw material is treated by processing method 1 (pressure sterilisation) as referred to in Chapter III of Annex IV or subjected to a treatment with acid or alkali for a period of at least two days, washing with water, and:
following an acid treatment, treating with alkaline solution for a period of at least 20 days; or
following an acid treatment, treating with an acid solution for a period of 10 to 12 hours.
The pH must then be adjusted and the material purified by means of filtration and sterilisation at 138 °C to 140 °C for 4 seconds.
After having been subjected to the process referred to in point (b), the photogelatine may undergo a drying process and, where appropriate, a process of pulverisation or lamination.
The photogelatine shall be wrapped, packaged in new packages, stored and transported in sealed leak-proof, labelled containers in a vehicle under satisfactory hygiene conditions.
If leakage is observed, the vehicle and containers shall be thoroughly cleaned and inspected before reuse.
Wrapping and packages containing the photogelatine must carry the words ‘photogelatine for the photographic industry only’.
Horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilizers or soil improvers, may be imported, provided that:
they have been produced in accordance with Chapter XII of Annex XIII; and
they are conveyed following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, directly to an approved or registered establishment or plant.
Unless they are kept for reference purposes or redispatched to the third country of origin, research and diagnostic samples and any products derived from the use of those samples shall be disposed of:
as waste by incineration;
by pressure sterilisation and subsequent disposal or use in accordance with Articles 12 to 14 of Regulation (EC) No 1069/2009; or
in accordance with point 4(b) of Section 1 of Chapter I of Annex VI in case:
of quantities not exceeding 2 000 ml; and
provided the samples or derived products have been produced in and dispatched from third countries or parts of third countries, from which Member States authorise imports of fresh meat of domestic bovine animals, which are listed in Part I of Annex II to Regulation (EU) No 206/2010.
they originate from:
third countries referred to in the column ‘third countries’ list’ of row 14 of Table 2 of Section 1 of Chapter II of this Annex;
in the case of trade samples which consist of milk, milk-based products or milk-derived products, authorised third countries listed in Annex I to Regulation (EU) No 605/2010;
they are accompanied by a health certificate as referred to in Chapter 8 of Annex XV; and
following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, they are transported directly to the approved or registered establishment or plant indicated in the authorisation of competent authority.
disposed of or used in accordance with Articles 12, 13 and 14 of Regulation (EC) No 1069/2009; or
redispatched to the third country of origin.
with dedicated equipment; or
with equipment which is cleaned and disinfected before it is used for purposes other than the testing.
During transport to the approved or registered establishment or plant, the trade samples must be packaged in leak-proof containers.
they originate from third countries referred to in the column ‘third countries’ list’ of row 14 of Table 2 of Section 1 of Chapter II;
their introduction has been authorised in advance by the competent authority of the Member State where the display item is intended to be used;
following the veterinary checks provided for in Directive 97/78/EC, display items must be sent directly to the authorised user.
the description of the material and the animal species of origin;
the category of the material;
the quantity of the material;
the place of dispatch of the material;
the name and the address of the consignor;
the name and the address of the consignee; and
details allowing the identification of the authorisation of the competent authority of destination.
redispatched to the third country of origin;
dispatched to another Member State or third country, if such dispatch has been authorised by the competent authority of the Member State or third country of destination in advance; or
disposed of in accordance with Articles 12, 13 and 14 of Regulation (EC) No 1069/2009.
Materials referred to in Article 26 shall be imported under the following conditions:
The materials shall be imported with a label attached to the packaging, container or vehicle which indicates ‘Prohibited in food, feed, fertilisers, cosmetics, medicinal products and medical devices’.
The materials shall be directly delivered to an approved or registered establishment or plant for the manufacture of derived products, other than the products referred to in point 1.
Unused or surplus materials shall be used or disposed of in accordance with Article 12 of Regulation (EC) No 1069/2009.
animal by-products from aquatic animals and derived products from aquatic animals;
aquatic invertebrates and derived products from aquatic invertebrates;
terrestrial invertebrates, including any of their transformation forms, such as larvae, and derived products therefrom;
products generated by the animals referred to in points (a), (b) and (c), such as fish eggs;
Category 3 material comprising of animals and parts thereof of the zoological orders of Rodentia and Lagomorpha.
Rules applicable to the export of the derived products listed below as referred to in Article 25(4):
[F11Derived products | Rules for export | |
---|---|---|
1 |
| The following derived products must comply at least with the conditions set out in points (a), (b), (d) and (e) of Section 2 of Chapter I of Annex XI:
|
2 | Blood products and intermediate products | Blood, blood products and intermediate products produced in the EU or imported into the EU in accordance with health requirements laid down in Annex XII or Sections 2 and 3 of Chapter II of this Annex for use outside the feed chain of farm animals , provided they comply with the import requirements of the third country of destination.] |
Textual Amendments
the consignment is accompanied by the official certificate or document, either in its original or as authenticated copy, or by the electronic equivalent of such certificate or document generated by use of IMSOC (1) , issued by the competent authority of the Member State of export;
the consignment is accompanied by a declaration from the competent authority in the Member State of destination in which that authority agrees to receive the consignment and indicates the place of destination;
the consignment complies with both of the following conditions:
it has remained sealed with an intact original seal, if the application of a seal prior to leaving the Union was mentioned in the original certificate referred to in point 1(a) or another official document issued by an authority in the Union;
it is accompanied by an official declaration of the competent authority or other public authority of the third country which refused the entry of the consignment indicating the reason for the refusal.
indicating the place and date of unloading, storage and re-loading and the seal number put on the container after reloading;
confirming that:
the seal on the vehicle or container of the consignment was only broken for the purpose of official controls;
the products were handled only to the extent necessary, and in particular
at the appropriate temperature required for the relevant types of animal by-products or derived products; and
in a way that prevents cross contamination of the products during the controls;
the vehicle or container was immediately re-sealed after the official controls
indicating the reasons for unloading and storage.
have not been subjected to any handling other than unloading, storage and re-loading;
were handled at the required temperature for the relevant types of animal by-products or derived products.] ]
Textual Amendments
[F12 [F13Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components ( ‘ the IMSOC Regulation ’ ) ( OJ L 261, 14.10.2019, p. 37 ).] ]
Textual Amendments
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