Commission Regulation (EC) No 1678/2006 of 14 November 2006 amending Regulation (EC) No 92/2005 as regards alternative means of disposal of and use of animal by-products (Text with EEA relevance)

of 14 November 2006

amending Regulation (EC) No 92/2005 as regards alternative means of disposal of and use of animal by-products

(Text with EEA relevance)

Preamble

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption ¹ , and in particular Articles 5(2)(g) and 6(2)(i) thereof,

Whereas:

(1) Regulation (EC) No 1774/2002 lays down rules concerning means of disposal of and ways of using animal by-products. It also provides for the possibility of additional means of disposal of and other ways of using animal by-products, to be approved following consultation of the appropriate scientific committee.

(2) On the basis of opinions issued by the Scientific Steering Committee and of the European Food Safety Authority (EFSA), to date six processes have been approved as alternative means of disposal of or ways of using animal by-products under Commission Regulation (EC) No 92/2005 of 19 January 2005 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards means of disposal or uses of animal by-products and amending its Annex VI as regards biogas transformation and processing of rendering fats ² .

(3) On the basis of a further application, the EFSA issued an opinion on 13 July 2006 on the safety of a thermo-mechanical process for biofuel production. The conditions under which that process was considered as a safe means of disposal for manure and digestive tract content and Category 3 material should therefore be taken into account by amending Regulation (EC) No 92/2005.

(4) Upon reconsideration of the risks to public and animal health, Category 2 material resulting from the approved biodiesel production process should be permitted for certain technical uses or for transformation into biogas.

(5) Regulation (EC) No 92/2005 should be amended accordingly.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 92/2005 is amended as follows:

1.	Article 2 is replaced by the following: ‘Article 2 Approval, treatment and use or disposal of Category 2 or 3 material 1. The following processes are approved and may be authorised by the competent authority for the treatment and use or disposal of Category 2 or 3 material: (a) alkaline hydrolysis process as defined in Annex I; (b) high pressure high temperature hydrolysis process as defined in Annex II; (c) high pressure hydrolysis biogas process as defined in Annex III; (d) biodiesel production process as defined in Annex IV; (e) Brookes gasification process as defined in Annex V; and (f) combustion of animal fat in a thermal boiler process as defined in Annex VI. The process of thermo-mechanical biofuel production as defined in Annex VII is approved and may be authorised by the competent authority for the treatment and disposal of manure and digestive tract content and Category 3 material. 2. The competent authority may authorise the use of other process parameters, on condition that such parameters provide for an equivalent reduction of risks for public and animal health, for the stages of: (a) the biodiesel production process as defined in Annex IV, point 1(b)(i); and (b) the process of combustion of animal fat in a thermal boiler as defined in Annex VI, point 1(c)(i).’;	(a)	alkaline hydrolysis process as defined in Annex I;	(b)	high pressure high temperature hydrolysis process as defined in Annex II;	(c)	high pressure hydrolysis biogas process as defined in Annex III;	(d)	biodiesel production process as defined in Annex IV;	(e)	Brookes gasification process as defined in Annex V; and	(f)	combustion of animal fat in a thermal boiler process as defined in Annex VI.	(a)	the biodiesel production process as defined in Annex IV, point 1(b)(i); and	(b)	the process of combustion of animal fat in a thermal boiler as defined in Annex VI, point 1(c)(i).’;
(a)	alkaline hydrolysis process as defined in Annex I;
(b)	high pressure high temperature hydrolysis process as defined in Annex II;
(c)	high pressure hydrolysis biogas process as defined in Annex III;
(d)	biodiesel production process as defined in Annex IV;
(e)	Brookes gasification process as defined in Annex V; and
(f)	combustion of animal fat in a thermal boiler process as defined in Annex VI.
(a)	the biodiesel production process as defined in Annex IV, point 1(b)(i); and
(b)	the process of combustion of animal fat in a thermal boiler as defined in Annex VI, point 1(c)(i).’;

2. in the title and in the first sentence of Article 3, ‘Annexes I to VI’ is replaced by ‘the Annexes’;

3.	(a): in paragraph 2, the following subparagraph is added: ‘However, material resulting from the biodiesel production process as defined in Annex IV shall be combusted.’;	(a)	in paragraph 2, the following subparagraph is added: ‘However, material resulting from the biodiesel production process as defined in Annex IV shall be combusted.’;
(a)	in paragraph 2, the following subparagraph is added: ‘However, material resulting from the biodiesel production process as defined in Annex IV shall be combusted.’;
(b)	‘(d): in the case of material resulting from the biodiesel production process as defined in Annex IV, used for the production of technical products.’;	‘(d)	in the case of material resulting from the biodiesel production process as defined in Annex IV, used for the production of technical products.’;
‘(d)	in the case of material resulting from the biodiesel production process as defined in Annex IV, used for the production of technical products.’;
(c)	paragraph 5 is deleted;

4. the Annexes are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union .

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 14 November 2006. For the Commission Markos KYPRIANOU Member of the Commission

¹ OJ L 273, 10.10.2002, p. 1 . Regulation as last amended by Commission Regulation (EC) No 208/2006 ( OJ L 36, 8.2.2006, p. 25 ).

² OJ L 19, 21.1.2005, p. 27 . Regulation as amended by Regulation (EC) No 2067/2005 ( OJ L 331, 17.12.2005, p. 12 ).

The Annexes to Regulation (EC) No 92/2005 are amended as follows:

1. in Annex IV, point 3 is deleted;

2.	the following Annex VII is added: ‘ANNEX VII THERMO-MECHANICAL BIOFUEL PRODUCTION PROCESS Thermo-mechanical biofuel production means treatment of animal by-products under the following conditions: 1. The animal by-products are loaded into a converter and subsequently treated at a temperature of 80 °C for a period of eight hours. During this period, the material is constantly reduced in size using appropriate mechanical abrasion equipment. 2. The material is subsequently treated to a temperature of 100 °C for at least two hours. 3. The particle size of the resulting material must not be larger than 20 millimetres. 4. The animal by-products are treated in such a manner that the time-temperature requirements laid down in paragraphs 1 and 2 are achieved at the same time. 5. During the heat treatment of the material, evaporated water is continually extracted from the air-space above the biofuel and is passed through a stainless steel condenser. The condensate is kept at a temperature of at least 70 °C for at least one hour before being discharged as waste water. 6. After the heat treatment of the material, the resulting biofuel from the converter is then discharged and automatically conveyed by a fully covered and interlocked conveyor to incineration or co-incineration on the same site. 7. A system of hazard analysis and critical control points is in place and maintained which allows for the control of the requirements laid down in paragraphs 1 to 6. 8. The process is carried out in a batch mode.’	1.	The animal by-products are loaded into a converter and subsequently treated at a temperature of 80 °C for a period of eight hours. During this period, the material is constantly reduced in size using appropriate mechanical abrasion equipment.	2.	The material is subsequently treated to a temperature of 100 °C for at least two hours.	3.	The particle size of the resulting material must not be larger than 20 millimetres.	4.	The animal by-products are treated in such a manner that the time-temperature requirements laid down in paragraphs 1 and 2 are achieved at the same time.	5.	During the heat treatment of the material, evaporated water is continually extracted from the air-space above the biofuel and is passed through a stainless steel condenser. The condensate is kept at a temperature of at least 70 °C for at least one hour before being discharged as waste water.	6.	After the heat treatment of the material, the resulting biofuel from the converter is then discharged and automatically conveyed by a fully covered and interlocked conveyor to incineration or co-incineration on the same site.	7.	A system of hazard analysis and critical control points is in place and maintained which allows for the control of the requirements laid down in paragraphs 1 to 6.	8.	The process is carried out in a batch mode.’
1.	The animal by-products are loaded into a converter and subsequently treated at a temperature of 80 °C for a period of eight hours. During this period, the material is constantly reduced in size using appropriate mechanical abrasion equipment.
2.	The material is subsequently treated to a temperature of 100 °C for at least two hours.
3.	The particle size of the resulting material must not be larger than 20 millimetres.
4.	The animal by-products are treated in such a manner that the time-temperature requirements laid down in paragraphs 1 and 2 are achieved at the same time.
5.	During the heat treatment of the material, evaporated water is continually extracted from the air-space above the biofuel and is passed through a stainless steel condenser. The condensate is kept at a temperature of at least 70 °C for at least one hour before being discharged as waste water.
6.	After the heat treatment of the material, the resulting biofuel from the converter is then discharged and automatically conveyed by a fully covered and interlocked conveyor to incineration or co-incineration on the same site.
7.	A system of hazard analysis and critical control points is in place and maintained which allows for the control of the requirements laid down in paragraphs 1 to 6.
8.	The process is carried out in a batch mode.’

. Regulation as last amended by Commission Regulation (EC) No 208/2006 (). ↩ ↩²
. Regulation as amended by Regulation (EC) No 2067/2005 (). ↩ ↩²