animal by-products and derived products which are excluded from human consumption under Community legislation; and

the following products which pursuant to a decision by an operator, which shall be irreversible, are destined for purposes other than human consumption:

entire bodies or parts of wild animals, other than wild game, which are not suspected of being infected or affected with a disease communicable to humans or animals, except for aquatic animals landed for commercial purposes;

entire bodies or parts of wild game which are not collected after killing, in accordance with good hunting practice, without prejudice to Regulation (EC) No 853/2004;

animal by-products from wild game and from wild game meat referred to in Article 1(3)(e) of Regulation (EC) No 853/2004;

oocytes, embryos and semen destined for breeding purposes;

raw milk, colostrum and products derived therefrom which are obtained, kept, disposed of or used on the farm of origin;

shells from shellfish with the soft tissue and flesh removed;

catering waste, except if it:

without prejudice to Community environmental legislation, material from vessels complying with Regulations (EC) No 852/2004 and (EC) No 853/2004, which has arisen in the course of their fishing operations and is disposed of at sea, except material derived from on-board evisceration of fish showing signs of disease, including parasites, that are communicable to humans;

raw pet food originating from retail shops, where the cutting and storage are performed solely for the purpose of supplying the consumer directly on the spot;

raw pet food derived from animals which are slaughtered on the farm of origin for private domestic consumption; and

excrement and urine other than manure and non-mineralised guano.

collected, identified and transported without undue delay; and

treated, used or disposed of in accordance with this Regulation.

for products referred to in Article 33(a) to (d), in case of risks to animal health;

for products referred to in Article 33(e) and (f), in case of risks to public or animal health.

pursuant to Community veterinary legislation; or

due to the presence of a serious transmissible disease:

the feeding of terrestrial animals of a given species other than fur animals with processed animal protein derived from the bodies or parts of bodies of animals of the same species;

the feeding of farmed animals other than fur animals with catering waste or feed material containing or derived from catering waste;

the feeding of farmed animals with herbage, either directly by grazing or by feeding with cut herbage, from land to which organic fertilisers or soil improvers, other than manure, have been applied unless the cutting or grazing takes place after the expiry of a waiting period which ensures adequate control of risks to public and animal health and is at least 21 days; and

the feeding of farmed fish with processed animal protein derived from the bodies or parts of bodies of farmed fish of the same species.

the checks and controls to be carried out to ensure the application of the prohibitions referred to in paragraph 1, including detection methods and tests to be used to verify the presence of materials originating from certain species and thresholds for insignificant amounts of processed animal proteins referred to in points (a) and (d) of paragraph 1 which are caused by adventitious and technically unavoidable contamination;

the conditions for the feeding of fur animals with processed animal protein derived from bodies or parts of bodies of animals of the same species; and

the conditions for the feeding of farmed animals with herbage from land to which organic fertilisers or soil improvers have been applied, in particular a modification of the waiting period as referred to in paragraph 1(c).

special conditions for the on-board handling and the disposal of material derived from on-board evisceration of fish showing signs of disease, including parasites, that are communicable to humans;

processing methods for animal by-products other than pressure sterilisation, in particular as regards the parameters to be applied for those processing methods, in particular the time, temperature, pressure and size of particles;

parameters for the transformation of animal by-products, including catering waste, into biogas or compost;

conditions for the incineration and co-incineration of animal by-products and derived products;

conditions for the combustion of animal by-products and derived products;

conditions for the generation and handling of animal by-products referred to in Article 10(c);

ensilage of material originating from aquatic animals;

permanent marking of animal by-products;

the application to land of certain animal by-products, organic fertilisers and soil improvers;

the use of certain animal by-products for feeding to farmed animals; and

the level of risk to public or animal health with respect to certain material which is considered as unacceptable as referred to in Article 14(d).

in points (c), (f) and (g) of the first subparagraph of paragraph 1, Member States may adopt or maintain national rules for:

in point (a) of the first subparagraph of paragraph 1, animal by-products referred to therein may be disposed of at sea, without prejudice to Community environmental legislation.

the prohibition of any subsequent use of the animal by-products or derived products for other purposes; and

the obligation to dispose of the animal by-products or derived products safely, or to re-dispatch them to their place of origin, if appropriate.

zoo animals;

circus animals;

reptiles and birds of prey other than zoo or circus animals;

fur animals;

wild animals;

dogs from recognised kennels or packs of hounds;

dogs and cats in shelters;

maggots and worms for fishing bait.

the feeding of the Category 1 material referred to in Article 8(b)(ii) and of material derived from zoo animals for feeding to zoo animals; and

the feeding of the Category 1 material referred to in Article 8(b)(ii) to endangered or protected species of necrophagous birds and other species living in their natural habitat, for the promotion of biodiversity.

conditions under which the collection and use as referred to in paragraph 1 may be authorised with respect to the movement, storage and use of Category 2 material and of Category 3 material for feeding, including in the case of newly emerging risks; and

conditions under which, in certain cases by way of derogation from the obligation laid down in Article 21(1), the feeding of Category 1 material as referred to in paragraph 2 of this Article may be authorised, including:

by burial of dead pet animals and equidae;

by burning or burial on site or by other means under official supervision which prevent the transmission of risks to public and animal health of Category 1 material referred to in Article 8(a)(v) and (b)(ii), Category 2 and Category 3 materials in remote areas;

by burning or burial on site or by other means under official supervision which prevent the transmission of risks to public and animal health of Category 1 material referred to in Article 8(b)(ii), Category 2 and Category 3 materials in areas where access is practically impossible or where access would only be possible under circumstances, related to geographical or climatic reasons or due to a natural disaster, which would pose a risk to the health and safety of the personnel carrying out the collection or where access would necessitate the use of disproportionate means of collection;

by means other than burning or burial on site, under official supervision, in the case of Category 2 and Category 3 materials which do not pose a risk to public and animal health, when the amounts of materials do not exceed a particular volume per week, this volume being determined in relation to the nature of the activities carried out and the species of origin of the animal by-products concerned;

by burning or burial on site, under conditions which prevent the transmission of risks to public and animal health, of animal by-products other than Category 1 material referred to in Article 8(a)(i) in the event of an outbreak of a notifiable disease, if transport to the nearest plant approved for processing or disposal of the animal by-products would increase the danger of propagation of health risks or, in case of a widespread outbreak of an epizootic disease, would mean that the disposal capacities of such plants were exceeded; and

by burning or burial on site, under conditions which prevent the transmission of risks to public and animal health, of bees and apiculture by-products.

the areas that they categorise as remote areas for the purpose of applying paragraph 1(b) and the reasons for that categorisation, and updated information concerning any change to such categorisation; and

the use they make of the authorisations provided for in points (c) and (d) of paragraph 1 with respect to Category 1 and Category 2 materials.

conditions aimed at ensuring control of risks to public and animal health in the event of burning and burial on site;

the maximum percentage of the animal population as referred to in paragraph 2;

the volume of animal by-products, in relation to the nature of activities and the species of origin, as referred to in paragraph 1(d); and

the list of diseases referred to in paragraph 1(e).

controlled in a manner which prevents their proliferation before disposal in accordance with this Regulation or the implementing measures thereof; or

reduced to a degree which is at least equivalent, for the relevant category of animal by-products, to the processing methods laid down pursuant to point (b) of the first subparagraph of Article 15(1).

either a measure authorising an alternative method of use or disposal of animal by-products or derived products; or

a measure rejecting the authorisation of such an alternative method.

models for commercial documents which are required to accompany animal by-products during transport; and

models for health certificates and the conditions governing the way they must accompany animal by-products and derived products during transport.

cases where a health certificate is required, having regard to the level of risk to public and animal health arising from certain derived products;

cases where, by way of derogation from the first subparagraph of paragraph 2 and having regard to the low level of risk to public and animal health arising from certain animal by-products or derived products, transport of derived products may take place without the documents or certificates referred to in that paragraph;

requirements for the identification, including labelling, and for the separation of different categories of animal by-products during transport; and

conditions to prevent risks to public and animal health arising during the collection and transport of animal by-products, including conditions for the safe transport of those products with respect to containers, vehicles and packaging material.

the other operators to which their animal by-products or derived products have been supplied; and

the operators from whom they have been supplied.

the information to be made available to the competent authorities;

the period of time during which this information must be kept.

before commencing operations, notify the competent authority of any establishments or plants under their control which are active at any stage of the generation, transport, handling, processing, storage, placing on the market, distribution, use or disposal of animal by-products and derived products;

provide the competent authority with information on:

processing of animal by-products by pressure sterilisation, by processing methods referred to in point (b) of the first subparagraph of Article 15(1) or by alternative methods authorised in accordance with Article 20;

disposal, as waste, by incineration of animal by-products and derived products, excluding establishments or plants which have a permit to operate in accordance with Directive 2000/76/EC;

disposal or recovery of animal by-products and derived products, if they are waste, by co-incineration, excluding establishments or plants which have a permit to operate in accordance with Directive 2000/76/EC;

use of animal by-products and derived products as fuel for combustion;

manufacturing of pet food;

manufacturing of organic fertilisers and soil improvers;

transformation of animal by-products and/or derived products into biogas or compost;

handling of animal by-products after their collection, by way of operations such as sorting, cutting, chilling, freezing, salting, removal of hides and skins or of specified risk material;

storage of animal by-products;

storage of derived products intended to be:

a particular category referred to in Articles 8, 9 or 10; or

more than one category referred to in Articles 8, 9 or 10, indicating if such operations are carried out:

are constructed in a way permitting their effective cleaning and disinfection and where appropriate the construction of floors facilitates the draining of liquids;

have access to adequate facilities for personal hygiene such as lavatories, changing rooms and washbasins for staff;

have appropriate arrangements for protection against pests, such as insects, rodents and birds;

keep installations and equipment in good condition and ensure that measuring equipment is calibrated regularly; and

have appropriate arrangements for the cleaning and the disinfection of containers and vehicles in place to avoid risks of contamination.

persons working in the unclean sector shall not enter the clean sector without first changing their work clothes and shoes or without having disinfected them;

equipment and machinery shall not be moved from the unclean to the clean sector without first being cleaned and disinfected; and

the operator shall establish a procedure relating to the movements of persons in order to monitor their movements and describe the correct use of footbaths and wheel baths.

animal by-products shall be handled in such a way as to avoid risks of contamination;

animal by-products shall be processed as soon as possible. After processing, derived products shall be handled and stored in such a way as to avoid risks of contamination;

where appropriate, during any processing applied to animal by-products and derived products every part of the animal by-product and derived products shall be treated to a given temperature for a given period of time and risks of re-contamination shall be prevented;

the operators shall check regularly the applicable parameters, particularly temperature, pressure, time, size of particles, where appropriate by automatic devices;

cleaning procedures shall be established and documented for all parts of the establishments or plants.

processing of animal by-products;

transformation of animal by-products into biogas and compost;

handling and storage of more than one category of animal by-products or derived products in the same establishment or plant;

manufacturing of pet food.

identify any hazards that must be prevented, eliminated or reduced to acceptable levels;

identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels;

establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards;

establish and implement effective monitoring procedures at critical control points;

establish corrective action when monitoring indicates that a critical control point is not under control;

establish procedures to verify that the measures outlined in points (a) to (e) are complete and working effectively. Verification procedures shall be carried out regularly;

establish documents and records commensurate with the nature and size of the businesses to demonstrate the effective application of the measures set out in points (a) to (f).

they have been developed in consultation with representatives of parties whose interests may be substantially affected, and have been disseminated by sectors of operators; and

their contents are practicable for the sectors to which they refer.

they are or they are derived from Category 3 material other than material referred to in Article 10(n), (o) and (p);

they have been collected or processed, as applicable, in accordance with the conditions for pressure sterilisation or other conditions to prevent risks arising to public and animal health in accordance with measures adopted pursuant to Article 15 and any measures which have been laid down in accordance with paragraph 2 of this Article; and

they come from approved or registered establishments or plants, as applicable for the animal by-product or derived product concerned.

they are derived from Category 2 or Category 3 material;

they have been produced in accordance with the conditions for pressure sterilisation or with other conditions to prevent risks arising to public and animal health, in accordance with the requirements laid down pursuant to Article 15 and any measures which have been laid down in accordance with paragraph 3 of this Article;

they come from approved or registered establishments or plants, as applicable; and

in the case of meat-and-bone meal derived from Category 2 material and processed animal proteins intended to be used as or in organic fertilisers and soil improvers, they have been mixed with a component to exclude the subsequent use of the mixture for feeding purposes and marked when required by measures adopted under paragraph 3.

public and animal health conditions for the production and use of organic fertilisers and soil improvers;

components or substances for the marking of organic fertilisers or soil improvers;

components to be mixed with organic fertilisers or soil improvers;

supplementary conditions, such as the methods to be used for marking and the minimum proportions to be observed when preparing the mixture, in order to exclude the use of such fertilisers or soil improvers for feeding purposes; and

cases where the composition or packaging allows the materials to be exempted from the mixing requirement.

from which no unacceptable risks to public and animal health arise;

which has been collected and transported from the point of collection to the manufacturing establishment or plant under conditions which exclude risks to public and animal health; or

which has been imported into the Community and transported from the point of first entry to the manufacturing establishment or plant under conditions which exclude risks to public and animal health.