Plants producing petfood, dogchews and technical products, other than organic fertilizers, soil improvers and fat derivatives derived from Category 2 material, must fulfil the following requirements:
they must have adequate facilities for storing and treating incoming material in complete safety; and
they must have adequate facilities for disposing of unused animal by-products remaining after the production of the products in accordance with this Regulation, or this material must be sent to a processing plant or to an incineration or co-incineration plant in accordance with this Regulation.
Textual Amendments
be subjected to a heat treatment of at least 90 °C throughout the substance of the final product;
be subjected to a heat treatment to at least 90 °C of the ingredients of animal origin; or
be produced as regards ingredients of animal origin exclusively using:
meat or meat products which have been subject to a heat treatment of at least 90 °C throughout their substance;
the following animal by-products or processed products which have been processed in accordance with the requirements of this Regulation: milk and milk based products, gelatine, hydrolysed protein, egg products, collagen, blood products, processed animal protein including fishmeal, rendered fat, fish oils, dicalcium phosphate, tricalcium phosphate or flavouring innards.
After the heat treatment, every precaution must be taken to ensure that such processed petfood is not exposed to contamination.
The processed petfood must be packaged in new packaging.]
Textual Amendments
Salmonella : absence in 25 g, n = 5, c = 0, m = 0, M = 0.
Enterobacteriaceae : n = 5, c = 2, m = 10, M = 300 in 1 g
Where:
=
number of samples to be tested;
=
threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
=
maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
=
number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
However, for canned petfood that has undergone the heat treatment referred to in paragraph 2, sampling and testing for Salmonella and Enterobacteriaceae may not be necessary.]
Textual Amendments
come from third countries that appear on the list in Part X of Annex XI;
come from petfood plants approved by the competent authority of the third country meeting the specific conditions laid down in this Regulation;
have been produced in accordance with this Regulation;
are accompanied:
in the case of canned petfood, by a certificate that conforms to the model laid down in Chapter 3(A) of Annex X,
in the case of processed petfood other than canned petfood, by a certificate that conforms to the model laid down in Chapter 3(B) of Annex X,
in the case of dogchews, by a certificate that conforms to the model laid down in Chapter 3(C) of Annex X, or
in the case of raw petfood, by a certificate that conforms to the model laid down in Chapter 3(D) of Annex X.
Trade in unprocessed manure of species other than poultry or equidae is prohibited, except for manure:
from an area which is not subject to restrictions by virtue of a serious transmissible disease, and
intended for application, under the supervision of the competent authorities, to land forming part of a single holding located on both sides of the border of two Member States.
However, the competent authority may grant specific approval for the introduction on to its territory of:
manure intended for processing in a technical plant or a biogas plant or in a composting plant approved by the competent authority in accordance with this Regulation with a view to the manufacture of the products referred to under Section II below. The competent authority must take account of the origin of the manure when approving such plants; or
manure intended for applying to land on a holding. Such trade can only occur with the consent of the competent authorities of both the Member States of origin and destination. When considering giving consent, the competent authorities must have particular regard to the origin of the manure, its destination and animal health and safety considerations.
A health certificate conforming to a model laid down under the procedure referred to in Article 33(2) must accompany the manure in such cases.
the manure must originate in an area which is not subject to restrictions by virtue of Newcastle disease or avian influenza;
in addition, unprocessed manure from poultry flocks vaccinated against Newcastle disease must not be dispatched to a region which has obtained Newcastle disease non-vaccinating status pursuant to Article 15(2) of Directive 90/539/EEC(1); and
a health certificate conforming to a model laid down under the procedure referred to in Article 33(2) must accompany the manure.
They must come from a technical plant, a biogas plant or a composting plant approved by the competent authority in accordance with this Regulation.
They must have been subjected to a heat treatment process of at least 70 °C for at least 60 minutes and they must have been subjected to reduction in spore-forming bacteria and toxic formation.]
[F4However, the competent authority may authorise the use of other standardised process parameters than those described in (b) provided an applicant demonstrates that such parameters ensure minimising of biological risks. This demonstration shall include a validation, which shall be carried out as follows:
Identification and analysis of possible hazards including the impact of input material, based on a full definition of the processing conditions, and a risk assessment, which evaluates how the specific processing conditions are achieved in practice under normal and atypical situations.
Validation of the intended process
by measuring the reduction of viability/infectivity of endogenous indicator organisms during the process, where the indicator is:
consistently present in the raw material in high numbers,
not less heat resistant to the lethal aspects of the treatment process, but also not significantly more resistant than the pathogens for which it is being used to monitor,
relatively easy to quantify and relatively easy to identify and confirm;
or
by measuring the reduction of viability/infectivity, during exposure, of a well-characterised test organism or virus introduced in a suitable test body into the starting material.
The validation referred to in point (ii) must demonstrate that the process achieves the following overall risk reduction:
for thermal and chemical processes by reduction of Enterococcus faecalis by at least 5 log10 and by reduction of infectivity titre of thermo resistant viruses such as parvovirus , where they are identified as a relevant hazard, by at least 3 log10,
for chemical processes also by reduction of resistant parasites such as eggs of ascaris sp. by at least 99,9 % (3 log10) of viable stages.
Designing a complete control programme including procedures for monitoring the process.
Measures ensuring continuous monitoring and supervision of the relevant process parameters fixed in the control programme when operating the plant.
Details on the relevant process parameters used in a plant as well as other critical control points must be recorded and maintained so that the owner, operator or their representative and the competent authority can monitor the operation of the plant. Records must be made available to the competent authority on request.
Information relating to a process authorised under this point must be made available to the Commission on request.]
[F4Representative samples of the manure taken during or immediately after processing at the plant in order to monitor the process must comply with the following standards:
Escherichia coli : n = 5, c = 5, m = 0, M = 1 000 in 1 g;
or
Enterococaceae : n = 5, c = 5, m = 0, M = 1 000 in 1 g;
and
Representative samples of the manure taken during or on withdrawal from storage at the technical, biogas or composting plant must comply with the following standards:
Salmonella : absence in 25 g: n = 5; c = 0; m = 0; M = 0
where:
=
number of samples to be tested;
=
threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m;
=
maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and
=
number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less.
Processed manure or processed manure products not complying with the above requirements shall be regarded as unprocessed;
They must be stored in such a way that once processed contamination or secondary infection and dampness is minimised. They must therefore be stored in:
well-sealed and insulated silos, or
properly sealed packs (plastic bags or ‘ big bags ’ ).]
Textual Amendments
F4 Substituted by Commission Regulation (EC) No 208/2006 of 7 February 2006 amending Annexes VI and VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards processing standards for biogas and composting plants and requirements for manure (Text with EEA relevance).
come from third countries that appear on the list in Part IX of Annex XI;
come from a plant approved by the competent authority of the third country meeting the specific conditions laid down in this Regulation;
satisfy the requirements of paragraph 5 above; and
[F1are accompanied by a health certificate that conforms to the model laid down in Chapter 17 of Annex X.]
come from third countries that appear on the list in Part VI (A) of Annex XI as applicable;
come from a technical plant meeting the specific conditions laid down in this Regulation or from the establishment of collection;
are accompanied by a health certificate that conforms to the model set out in Chapter 4(C) or Chapter 4(D) of Annex X as appropriate.
in slaughterhouses approved in accordance with Community legislation;
in slaughterhouses approved and supervised by the competent authority of the third country; or
from live animals in facilities approved and supervised by the competent authority of the third country.
the products 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 case of blood products not treated in accordance with point (a) the products originate from a country or region:
where no case of rinderpest, peste des petits ruminants and Rift Valley fever has been recorded for 12 months and in which vaccination has not been carried out against those diseases for at least 12 months,
where no case of foot-and-mouth disease has been recorded for 12 months and in which vaccination has not been carried out against this disease for at least 12 months, or
where no case of foot-and-mouth disease has been recorded for 12 months and in which vaccination programmes against foot-and-mouth disease are being officially carried out and controlled in domestic ruminant animals for at least 12 months; in this case, following the border check 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 technical 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 points (i) and (ii), in the case of animals other than Suidae and Tayassuidae , one of the following conditions must be complied with:
in the country or region of origin no case of vesicular stomatitis and bluetongue (including the presence of seropositive animals) has been recorded for 12 months and vaccination has not been carried out against those diseases for at least 12 months in the susceptible species,
following the border check 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 technical 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 points (i) and (ii), in the case of Suidae and Tayassuidae , in the country or region of origin no case of swine vesicular disease, classical swine fever and African swine fever has been recorded for at least 12 months, vaccination has not been carried out against those diseases for 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 12 months and vaccination has not been carried out against this disease for at least 12 months in the susceptible species,
following the border check 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 technical 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.
the products 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 originate from a country or region:
which has been free from Newcastle disease and highly pathogenic avian influenza as defined in the Terrestrial Animal Health Code of the OIE,
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.]
Textual Amendments
come from equidae which show no signs of the serious transmissible diseases referred to in Directive 90/426/EEC(2) or of any other serious transmissible disease to which equidae are susceptible; and
have been obtained in bodies or centres not subject to health restrictions pursuant to that Directive.
[F6it comes from equidae born and raised in a third country that appears on the list of part XIII of Annex XI;]
it was obtained, processed and dispatched in conformity with the following conditions:
it comes from a country where the following diseases are compulsorily notifiable: African horse sickness, dourine, glanders, equine encephalomyelitis (all types including VEE), equine infectious anaemia, vesicular stomatitis, rabies, anthrax;
it was obtained, under the supervision of a veterinarian, from equidae which, at the time of collection, were free from clinical signs of infectious disease;
it was obtained from equidae that have remained since birth in the territory or, in case of official regionalisation according to Community legislation, in parts of the territory of a third country in which:
Venezuelan equine encephalomyelitis had not occurred during the last two years,
dourine had not occurred during the last six months, and
glanders had not occurred during the last six months;
it was obtained from equidae that had never been present on a holding that had been subject to prohibition for animal health reasons or where:
in the case of equine encephalomyelitis, the date on which all the equidae suffering from the disease were slaughtered was at least six months before the date of collection,
in the case of infectious anaemia, all the infected animals had been slaughtered and the remaining animals showed a negative reaction to two Coggins tests carried out three months apart,
in the case of vesicular stomatitis, the prohibition was lifted at least six months before the date of collection,
in the case of rabies, the last recorded case was at least a month before the date of collection,
in the case of anthrax, the last recorded case was at least 15 days before the date of collection, or
all the animals of species susceptible to the disease located on the holding were slaughtered and the premises disinfected, at least 30 days before the date of collection (or, in the case of anthrax, at least 15 days before);
it has undergone all precautions to avoid contamination with pathogenic agents during production, handling and packaging;
it was packed in sealed impermeable containers clearly labelled ‘serum from equidae’ and bearing the registration number of the establishment of collection;
it comes from a plant approved by the competent authority of the third country meeting the specific conditions laid down in this Regulation; and
[F6it is accompanied by a health certificate that conforms to the model set out in Chapter 4(A) of Annex X]
Textual Amendments
[F1to hides and skins of ungulates complying with the requirements of Regulation (EC) No 853/2004 of 29 April 2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (3) ;]
to hides and skins of ungulates having undergone the complete process of tanning;
to ‘wet blue’;
to ‘pickled pelts’; and
to limed hides (treated with lime and in brine at a pH of 12 to 13 for at least eight hours).
dried;
dry-salted or wet-salted for at least 14 days prior to dispatch;
salted for seven days in sea salt with the addition of 2 % of sodium carbonate;
dried for 42 days at a temperature of at least 20 oC; or
[F7preserved by a process other than tanning specified by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3).]
Textual Amendments
F7 Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.
the hides and skins have been treated in accordance with paragraph 2; and
the consignment has not been in contact with other animal products or live animals presenting a risk of spreading a serious transmissible disease.
they have been obtained from animals referred to in Article 6(1)(b) or (c);
[F6 [F1they come from a third country or, in the case of regionalisation in accordance with Community legislation, from a part of a third country, appearing on the list set out in Part XIV(A) of Annex XI and which, as appropriate to the species concerned:]
for at least 12 months before dispatch, has been free from the following diseases:
classical swine fever,
African swine fever, and
rinderpest, and
has been free for at least 12 months before dispatch from foot-and-mouth disease and where, for 12 months before dispatch, no vaccination has been carried out against foot-and-mouth disease;]
they have been obtained from:
animals that have remained in the territory of the country of origin for 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;
they have undergone all precautions to avoid recontamination with pathogenic agents; and
a certificate conforming to the model laid down in Chapter 5(A) of Annex X accompanies them.
they have been obtained from animals referred to in Article 6(1)(b), (c) or (k);
[F1they come either from:
a third country or, in the case of regionalisation in accordance with Community legislation, from a part of a third country, appearing on the list set out in Part XIV(B) of Annex XI from which imports of fresh meat of the corresponding species are authorised and they have been treated in accordance with paragraph 2(a), (b) and (c) of A; or
a third country appearing on the list set out in Part XIV(B) of Annex XI and they have been treated in accordance with paragraph 2(c) or (d) of A; or
equidae or ruminant animals from a third country appearing on the list set out in Part XIV(C) of Annex XI, which have been treated in accordance with paragraph 2(a), (b) and (c) of A and after treatment have been kept separate for at least 21 days;
in the case of salted hides and skins transported by ship, they have been treated in accordance with paragraphs 2(b) or (c) of A and have been kept separated after treatment during transportation for at least 14 days in the case of paragraph (b) or seven days in the case of paragraph (c) before importation and the health certificate accompanying the consignment attests such treatment and the duration of the transportation; and
a health certificate conforming to the model health certificate laid down in Chapter 5(B) of Annex X, or, in the case of hides and skins referred to in paragraph 6(b)(iii) of C of this Annex, an official declaration conforming to the model laid down in Chapter 5 (C) of Annex X, accompanies them.]
of ungulates and birds having undergone a complete taxidermy treatment ensuring their preservation at ambient temperatures; and
of species other than ungulates and birds,
are not subject to any ban or restriction for reasons of animal health.
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; or
comply with the conditions laid down in paragraphs 3 or 4 if they come from animals originating in an area subject to restrictions as a result of the presence of serious transmissible diseases to which animals of the species concerned are susceptible.
have been immersed in boiling water for an appropriate time so as to ensure that any matter other than bone, horns, hooves, claws, antlers or teeth is removed;
have been disinfected with a product authorised by the competent authority, in particular with hydrogen peroxide where parts consisting of bone are concerned;
be packaged, immediately after treatment, 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; and
be accompanied by a document or certificate certifying that the above conditions have been met.
have been either:
dried, or
dry- or wet-salted for a minimum of 14 days before dispatch, or
[F7preserved by a treatment other than tanning approved by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 33(3);]
be packaged, immediately after treatment, 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; and
be accompanied by a document or certificate certifying that the above conditions have been met.
a certificate that conforms to the model laid down in Chapter 6(A) of Annex X accompanies them; and
they comply with the requirements of paragraphs 3 and 4. 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[F6;]
[F8they come from a third country appearing on the list set out in part XV (A) of Annex XI.]
Textual Amendments
[F6that appear on the lists set out in part XV(B) and (C) of Annex XI as appropriate; and]
from which the importation of all categories of fresh meat of the corresponding species is authorised.
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, immediately after treatment, 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; and
a certificate conforming to the model laid down in Chapter 6(B) of Annex X accompanies them.
Unprocessed wool, unprocessed hair, unprocessed pig bristles and unprocessed feathers and parts of feathers must have been obtained from animals referred to in Article 6(1)(c) or (k). They must be securely enclosed in packaging and dry. However, in the case of unprocessed feather and part of feathers sent directly from the slaughterhouse to the processing plant, the competent authority may allow derogation from the dry requirement, provided that:
all necessary measures are taken to avoid any possible spread of disease;
the transport takes place in leak-proof containers and/or vehicles which must be cleansed and disinfected immediately after each use; and
the Member State notifies the Commission when such derogation is given.
Movements of pig bristles from regions in which African swine fever is endemic are prohibited except for pig bristles that have:
been boiled, dyed or bleached; or
undergone some other form of treatment which is certain to kill pathogenic agents, provided that evidence to this effect is submitted in the form of a certificate from the veterinarian responsible for the place of origin. Factory washing may not be regarded as a form of treatment for the purposes of this provision.]
carried by travellers for their private use; or
in the form of consignments sent to private individuals for non-industrial purposes.
the pig bristles were obtained from animals originating, and slaughtered in a slaughterhouse, in the country of origin; and
either:
where no case of African swine fever has occurred during the previous 12 months, a certificate conforming to the model laid down in Chapter 7(A) of Annex X accompanies the consignment; or
where one or more cases of African swine fever have occurred during the previous 12 months, a certificate conforming to the model laid down in Chapter 7(B) of Annex X accompanies the consignment[F6;]
[F8they come from a third country that appears on the list of part VIII of Annex XI as appropriate.]
securely enclosed in packaging and dry; and
sent directly to the technical plant or to an intermediate plant in conditions such that any spread of pathogenic agents is avoided.
Member States must authorise the importation of processed feathers and parts of feathers if:
they are treated decorative feathers, treated feathers carried by travellers for their private use or consignments of treated feathers sent to private individuals for non-industrial purposes; or
they are accompanied by a commercial document stating that the feathers or parts of feathers have been treated with a steam current or by another method ensuring the inactivation of pathogens and are securely enclosed in packaging and dry.]
Textual Amendments
not come from an area which is subject of a prohibition order associated with an occurrence of:
American foulbrood ( Paenibacillus larvae larvae ), except where the competent authority has assessed the risk to be negligible, issued a specific authorisation for use only in that Member State, and taken all other necessary measures to ensure no spread of that disease;
acariosis ( Acarapis woodi (Rennie), except where the area of destination has obtained additional guarantees in accordance with Article 14(2) of Directive 92/65/EEC (6) ;
small hive beetle ( Aethina tumida ); or
Tropilaelaps spp. ( Tropilaelaps spp); and
meet the requirements provided for in Article 8(a) of Directive 92/65/EEC.
come from third countries that appear on the list in Part XII of Annex XI;
either:
have been subjected to a temperature of – 12 °C or lower for at least 24 hours; or
in the case of wax, the material has been refined or rendered before importation; and
are accompanied by a health certificate that conforms to the model set out in Chapter 13 of Annex X.]
has been refined or rendered before importation; and
is accompanied by a commercial document attesting that refinement or rendering.
the products are dried before export and not chilled or frozen;
the products are conveyed only by land and sea from their country of origin direct to a border inspection post in the Community and are not transhipped at any port or place outside the Community;
following the document checks provided for in Directive 97/78/EC, the products are conveyed directly to the technical plant[F6;]
[F8they come from a third country appearing on the list set out in part XVII of Annex XI.]
a commercial document stamped by the competent authority supervising the establishment of origin, including the following information:
the country of origin,
the name of the establishment of production,
the nature of the product (dried bone/dried bone product/dried horns/dried horn products/dried hooves/dried hoof products), and
the fact that the product was:
derived from healthy animals slaughtered in a slaughterhouse, or
dried for 42 days at an average temperature of at least 20 oC, or
heated for one hour to at least 80 oC to the core before drying, or
[F6ashed for one hour to at least 800 o C to the core before drying, or]
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 fertilizers or soil improvers; and
[F6a declaration of the importer that conforms to the model laid down in Chapter 16 of Annex X and that must be in at least one official language of the Member State through which the consignment first enters the Community and in at least one official language of the Member State of destination.]
Member States must authorise the importation of animal by-products intended for the manufacture of feed including petfood, and for pharmaceutical products and other technical products if they:
come from third countries appearing on the lists set out in part VI and VII(A) and (B) of Annex XI as appropriate;
consist only of animal by-products referred to in Article 6(1)(a) to (j) and/or, when intended to be used for petfood, material derived from animals treated as referred to in the second paragraph of Article 28;
[F1however, animal by-products for use in feed for farmed fur animals or for use in raw petfood must consist of animal by-products referred to in Article 6(1)(a) and (b) only;]
have been deep-frozen at the plant of origin or have been preserved in accordance with Community legislation in such a way to prevent spoiling between dispatch and delivery to the plant of destination;
have undergone all precautions to avoid contamination with pathogenic agents;
were packed in new packaging preventing any leakage;
[F1are accompanied by a certificate that conforms to one of the models set out in Chapter 3(D), 3(F) or 8 of Annex X;]
following the border 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 either:
to a petfood or technical plant, which has given the guarantee that the animal by-products shall be used only for the purpose of producing petfood or technical products as appropriate, as specified by the competent authority if necessary, and shall not leave the plant untreated other than for direct disposal; or
to an intermediate plant; or
to an authorised and registered user or collection centre, which has given the guarantee that the animal by-products shall be used only for permitted purposes, as specified by the Competent Authority if necessary;
and
in the case of raw material for petfood production derived from animals which have been treated with certain substances prohibited in accordance with Directive 96/22/EC, as referred to in the second paragraph of Article 28 of this Regulation, it shall:
be marked in the third country before entry into the territory of the Community by a cross of liquefied charcoal or activated carbon, on each outer side of each frozen block, 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 territory of the Community 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 7(a) above;
or
an intermediate plant in accordance with point 7(b) above and from there directly to the petfood plant referred to under (i), provided that the intermediate plant:
only handles material covered by this point 8.1, or
only handles material destined for a petfood plant as referred to under (i);
and
be manipulated to remove the marking provided for in (a) and (b) only in the petfood plant of destination and only immediately prior to use of the material for the manufacture of petfood;
where a consignment is made up of raw material, which has been treated as referred to in 8.1 above and other non-treated raw material, all the raw materials in the consignment must be marked as laid down in point 8.1(a) and (b) above.
the marking provided for in point 8.1(a) and (b) and 8.2 shall remain visible from the dispatch and until the delivery to the petfood plant of destination.]
Textual Amendments
F10 Substituted by Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation (Text with EEA relevance).
comes from a third country that appears on a Community list set out in part IV of Annex XI;
has been produced in accordance with this Regulation; and
is accompanied by a health certificate that conforms to the model set out in Chapter 10(B) of Annex X.
the rendered fats will not be diverted for any use other than further processing by a method that at least meets the standards of one of the processes referred to in Chapter III of Annex VI; and
the resulting fat derivatives shall only be used in organic fertiliser or soil improvers or other technical uses, other than in cosmetics, pharmaceuticals and medical devices.
whether or not the fat derivatives derive from category 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 Chapter III of Annex VI; and
shall only be used in organic fertiliser or soil improvers or other technical uses, other than in cosmetics, pharmaceuticals and medical devices.
The following conditions apply in addition to the requirements for approval laid down in Chapter I.
be packed in new or sterilised packaging; or
transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved by the competent authority before use.
come from third countries that appear on the list set out in part VII(C) of Annex XI;
come from petfood plants approved by the competent authority of the third country meeting the specific conditions laid down in Article 18;
have been produced in accordance with this Regulation; and
are accompanied by a health certificate that conforms to the model set out in Chapter 3(E) of Annex X.]
Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of poultry and hatching eggs (OJ L 303, 31.10.1990, p. 6). Directive as last amended by Commission Decision 2000/505/EC (OJ L 201, 9.8.2000, p. 8).
Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (OJ L 224, 18.8.1990, p. 42). Directive as last amended by Commission Decision 2001/298/EC (OJ L 102, 12.4.2001, p. 63).
[F1 OJ L 139, 30.4.2004, p. 55 ; corrected version ( OJ L 226, 25.6.2004, p. 22 ).]
OJ L 61, 3.3.1997, p. 1. Regulation as last amended by Commission Regulation No 1579/2001 (OJ L 209, 2.8.2001, p. 14).
[F6Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC ( OJ L 268, 14.9.1992, p. 54 ).]
Textual Amendments