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Commission Regulation (EU) No 142/2011Show full title
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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This is a Regulation originating from the EU
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CHAPTER II SPECIFIC REQUIREMENTS FOR THE IMPORTATION INTO AND TRANSIT THROUGH THE UNION OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS FOR USES OUTSIDE THE FEED CHAIN FOR FARMED ANIMALS OTHER THAN FUR ANIMALS
Section 1 Specific requirements
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:
(a)
they must consist of or have been produced from animal by-products referred to in the column ‘raw materials’ of Table 2;
(b)
they must comply with the import and transit conditions set out in the column ‘import and transit conditions’ of Table 2;
(c)
they must come from a third country or part of a third country listed in the column ‘third countries’ list’ of Table 2; and
(d)
they shall be accompanied during transportation to the point of entry into the Union where the veterinary checks take place by the health certificate or other document, as applicable, referred to in the column ‘certificates/ model documents’ of Table 2; or
(e)
they shall be 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.
Table 2
Section 2 Imports of blood and blood products, excluding from equidae, for the manufacture of derived products for uses outside the feed chain for farmed animals
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:
1.
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.
2.
The 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:
(a)
in slaughterhouses approved in accordance with Union legislation;
(b)
in slaughterhouses approved and supervised by the competent authority of the third country; or
(c)
from live animals in facilities approved and supervised by the competent authority of the third country.
3.1..
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):
(a)
the products must have undergone one of the following treatments guaranteeing the absence of pathogens of the diseases referred to in point (b):
(i)
heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;
(ii)
irradiation at 25 kGy by gamma rays, followed by an effectiveness check;
(iii)
heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check;
(iv)
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;
(b)
in the case of blood products not treated in accordance with point (a) the products must originate from a third country or region:
(i)
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;
(ii)
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.
3.2..
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:
(a)
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;
(b)
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.
3.3..
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:
(a)
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;
(b)
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.
4.
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):
(a)
the products must have undergone one of the following treatments guaranteeing the absence of pathogens of the diseases referred to in point (b):
(i)
heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;
(ii)
irradiation at 25 kGy by gamma rays, followed by an effectiveness check;
(iii)
heat treatment of at least 70 °C throughout their substance, followed by an effectiveness check;
(b)
in case of blood products not treated in accordance with point (a) the products must originate from a third country or region:
(i)
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;
(ii)
which during the last 12 months has not carried out vaccination against avian influenza;
(iii)
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.
Section 3 Imports of blood and blood products from equidae
The following requirements shall apply to the import of blood and blood products from equidae:
1.
The 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 either in:
(a)
slaughterhouses
(i)
approved in accordance with Regulation (EC) No 853/2004; or
(ii)
approved and supervised by the competent authority of the third country; or
(b)
facilities approved and furnished with a veterinary approval number and supervised by the competent authority of the third country for the purpose of collecting blood from equidae for the production of blood products for purposes other than feeding.
2.
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:
(a)
African horse sickness in accordance with points (a) and (b) of the first subparagraph of Article 5(2) of Directive 2009/156/EC;
(b)
Venezuelan equine encephalomyelitis for a period of at least two years;
(c)
glanders:
(i)
for a period of three years; or
(ii)
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;
(d)
in the case of blood products other than serum, vesicular stomatitis for a period of at least six months.
3.
Blood products must come from an establishment or plant which has been approved or registered by the competent authority of the third country.
4.
Blood and blood products shall be packed and labelled in accordance with point 3 of Chapter IV of Annex XIII.
Section 4 Imports of hides and skins of ungulates
The following requirements shall apply to the import of hides and skins of ungulates:
1.
Fresh or chilled hides and skins may be imported if:
(a)
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:
(i)
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
(ii)
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;
(b)
they have been obtained from:
(i)
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;
(ii)
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;
(iii)
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
(iv)
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
(c)
they have undergone all precautions to avoid recontamination with pathogenic agents.
2.
Treated hides and skins referred to in point C.2 of Chapter V of Annex XIII may be imported without any restrictions.
3.
Other treated hides and skins may be imported if:
(a)
they come either from:
(i)
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;
(ii)
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
(iii)
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
(b)
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.
4.
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.
Section 5 Imports of game trophies and other preparations from animals
The following requirements shall apply to the import of game trophies and other preparations from animals:
1.
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.
2.
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.
3.
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:
(a)
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;
(b)
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.
Section 6 Imports of treated feathers, parts of feathers and down
Treated feathers and parts of feathers and down may be imported:
(a)
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
(b)
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
(c)
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.
Section 7 Imports of bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) intended for use other than as feed material, organic fertilisers or soil improvers
1.Bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) may be imported to produce derived products for uses outside the feed chain if:
(a)
the products are dried before export to the Union and not chilled or frozen;
(b)
the products are conveyed only by land and sea from their third country of origin direct to a border inspection post of entry into the Union and are not transhipped at any port or place outside the Union;
(c)
following the document checks provided for in Directive 97/78/EC, the products are conveyed directly to the registered establishment or plant of destination.
2.Each consignment must be accompanied by a commercial document stamped by the competent authority supervising the establishment of origin, including the following information:
(a)
the third country of origin;
(b)
the name of the establishment or plant of production;
(c)
the nature of the product (dried bone/dried bone product/dried horns/dried horn products/dried hooves/dried hoof products), and
(d)
confirmation of the fact that the product was:
(i)
derived from healthy animals slaughtered in a slaughterhouse;
(ii)
dried for a period of 42 days at an average temperature of at least 20 °C;
(iii)
heated for one hour to at least 80 °C to the core before drying;
(iv)
ashed for one hour to at least 800 °C to the core before drying;
(v)
underwent an acidification process such that the pH was maintained at less than 6 to the core for at least one hour before drying, and
is not intended at any stage to be diverted for any use in food, feed material, organic fertilisers or soil improvers.
3.On dispatch to the Union, the material must be enclosed in sealed containers or vehicles or carried in bulk in a ship.
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.
4.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 material must be transported directly to the registered establishment or plant of destination.
Section 8 Imports of animal by-products for the manufacture of feed for fur animals, petfood, other than raw petfood, and derived products for uses outside the feed chain for farmed animals
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:
1.
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;
2.
the animal by-products have undergone all precautions to avoid contamination with pathogenic agents;
3.
the animal by-products were packed in new packaging preventing any leakage or in packaging which has been cleaned and disinfected before use;
4.
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)
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;
(b)
an establishment or plant which has been approved in accordance with Article 24(1)(h) of Regulation (EC) No 1069/2009;
(c)
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
(d)
an establishment or plant which has been approved in accordance with Article 24(1)(a) of Regulation (EC) No 1069/2009; and
5.1..
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:
(a)
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;
(b)
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;
(c)
be transported directly to:
(i)
the petfood plant of destination in accordance with point 4(a); or
(ii)
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
(d)
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;
5.2..
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;
5.3..
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;
6.
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.
Section 9 Imports of rendered fats for certain purposes outside the feed chain for farmed animals
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:
(a)
they are derived from:
(i)
in the case of materials destined to the production of biodiesel, animal by-products referred to in Articles 8, 9 and 10 of Regulation (EC) No 1069/2009;
(ii)
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;
(iii)
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), (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;
(b)
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;
(c)
in the case of fat from ruminant origin, insoluble impurities in excess of 0,15 % by weight have been removed;
(d)
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;
(e)
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
(f)
they bear labels, on the packaging or container indicating ‘NOT FOR HUMAN OR ANIMAL CONSUMPTION’.
Section 10 Imports of fat derivatives
1.Fat derivatives may be imported if the health certificate accompanying the consignment certifies:
(a)
whether the fat derivatives derive from Category 1, 2 or 3 materials;
(b)
in the case of fat derivatives produced from Category 2 material, that the products:
(i)
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
(ii)
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;
(c)
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.
2.The health certificate referred to in point 1 must be presented to the competent authority at the border inspection post at the first point of entry of the goods into the Union, and thereafter a copy must accompany the consignment until its arrival at the plant of destination.
3.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 fat derivatives shall be transported directly to the registered establishment or plant of destination.
Section 11 Imports of photogelatine
1.Gelatine which has been produced from material containing bovine vertebral column comprising of Category 1 material in accordance with Article 8(b) of Regulation (EC) No 1069/2009 and which is intended for the photographic industry (photogelatine) may be imported, provided the photogelatine:
(a)
originates from one of the plants of origin indicated in Table 3;
(b)
has been produced in accordance with point 6;
(c)
is imported through one of the border inspection posts of first entry into the Union indicated in Table 3; and
(d)
is destined for production in an approved photographic factory indicated in Table 3.
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 |
2.Once the photogelatine has entered the Member State of destination, it shall not be traded between Member States but shall only be used in the approved photographic factory in the same Member State of destination and solely for photographic production purposes.
3.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 photogelatine shall be transported directly to the approved photographic factory of destination.
4.The transport referred to in point 3 shall be carried out in vehicles or containers in which the photogelatine is physically separated from any products intended for food or feed.
5.In the approved photographic factory of destination, the operator shall ensure that any surpluses or residues of and other waste derived from the photogelatine are:
(a)
transported in sealed leak-proof containers labelled ‘for disposal only’ in vehicles under satisfactory hygiene conditions;
(b)
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.
6.Photogelatine shall be produced according to the following requirements:
(a)
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.
(b)
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:
(i)
following an acid treatment, treating with alkaline solution for a period of at least 20 days; or
(ii)
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.
(c)
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.
(d)
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.
(e)
Wrapping and packages containing the photogelatine must carry the words ‘photogelatine for the photographic industry only’.
Section 12 Imports of horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilisers or soil improvers
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:
1.
they have been produced in accordance with Chapter XII of Annex XIII; and
2.
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.
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