TITLE I

GENERAL PROVISIONS
CHAPTER II

Disposal and use of animal by-products and derived products
Section 3

Derogations

Derogations
Article 16
By way of derogation from Articles 12, 13 and 14, animal by-products may be:
1. in the case of animal by-products referred to in point (a) of the first subparagraph of Article 15(1), handled and disposed of in accordance with special conditions laid down pursuant to that point;
2. used for research and other specific purposes in accordance with Article 17;
3. in the case of animal by-products referred to in Article 18, used for special feeding purposes in accordance with that Article;
4. in the case of animal by-products referred to in Article 19, disposed of in accordance with that Article;
5. disposed of or used in accordance with alternative methods which have been authorised in accordance with Article 20, based on parameters which may include pressure sterilisation or other requirements of this Regulation or the implementing measures thereof;
6. in the case of Category 2 and Category 3 materials and if authorised by the competent authority, used for the preparation and application to land of bio-dynamic preparations as referred to in Article 12(1)(c) of Regulation (EC) No 834/2007;
7. in the case of Category 3 material and, if authorised by the competent authority, used for feeding to pet animals;
8. in the case of animal by-products, except for Category 1 material, which arise in the course of surgical intervention on live animals or during birth of animals on farm and, if authorised by the competent authority, disposed of on that farm.

Research and other specific purposes
Article 17
1
The competent authority may, by way of derogation from Articles 12, 13 and 14, authorise the use of animal by-products and derived products for exhibitions, artistic activities, and for diagnostic, educational or research purposes under conditions which ensure the control of risks to public and animal health.
Such conditions shall include:
a
the prohibition of any subsequent use of the animal by-products or derived products for other purposes; and
b
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.
2
In the case of risks to public and animal health which require the adoption of measures for the whole territory of the Community, in particular in the case of newly emerging risks, harmonised conditions for the import and use of the animal by-products and derived products referred to in paragraph 1 may be laid down. Such conditions may include requirements regarding storage, packaging, identification, transport and disposal.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).

Special feeding purposes
Article 18
1
The competent authority may, by way of derogation from Articles 13 and 14, authorise, under conditions which ensure the control of risks to public and animal health, the collection and use of Category 2 material, provided that it comes from animals which were not killed or did not die as a result of the presence or suspected presence of a disease communicable to humans or animals, and of Category 3 material for feeding to:
a
zoo animals;
b
circus animals;
c
reptiles and birds of prey other than zoo or circus animals;
d
fur animals;
e
wild animals;
f
dogs from recognised kennels or packs of hounds;
g
dogs and cats in shelters;
h
maggots and worms for fishing bait.
2
The competent authority may authorise, by way of derogation from Article 12, and in accordance with the conditions laid down pursuant to paragraph 3 of this Article:
a
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
b
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.
3
Measures for the implementation of this Article may be laid down relating to the following:
a
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
b
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:
1. the endangered or protected species of necrophagous birds and other species in certain Member States to which such material may be fed;
2. measures to prevent risks to public and animal health.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).

Collection, transport and disposal
Article 19
1
The competent authority may, by way of derogation from Articles 12, 13, 14 and 21, authorise the disposal:
a
by burial of dead pet animals and equidae;
b
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;
c
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;
d
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;
e
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
f
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.
2
The animal population of a particular species in the remote areas referred to in paragraph 1(b) shall not exceed a maximum percentage of the animal population of this species in the Member State concerned.
3
Member States shall make available to the Commission information on:
a
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
b
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.
4
Measures for the implementation of this Article shall be laid down relating to the following:
a
conditions aimed at ensuring control of risks to public and animal health in the event of burning and burial on site;
b
the maximum percentage of the animal population as referred to in paragraph 2;
c
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
d
the list of diseases referred to in paragraph 1(e).
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).