The processes of alkaline hydrolysis as defined in Annex I, of high pressure hydrolysis biogas as defined in Annex III, of biodiesel production as defined in Annex IV and of combustion of animal fat in a thermal boiler as defined in Annex VI are approved and may be authorised by the competent authority for the treatment and disposal of Category 1 material.
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 rendered fats (Text with EEA relevance)
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 rendered fats (Text with EEA relevance)
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 Article 4(2)(e), Article 5(2)(g), Article 6(2)(i) and Article 32(1) thereof,
Whereas:
Regulation (EC) No 1774/2002 provides for rules concerning the means of disposal and uses of animal by-products. It also provides for the possibility for additional means of disposal and uses of animal by-products to be approved following consultation of the appropriate scientific committee.
The Scientific Steering Committee (SSC) issued an opinion on 10 and 11 April 2003 on six alternative processing methods for safe treatment and disposal of animal by-products. According to that opinion five processes are considered as safe for the disposal of and/or uses of Categories 2 and 3 material under certain conditions.
The SSC issued a final opinion and report on 10 and 11 April 2003 on a treatment of animal waste by means of high temperature and high pressure alkaline hydrolysis, providing guidance on the possibilities to use alkaline hydrolysis and on its risks for the disposal of Categories 1, 2 and 3 material.
The European Food Safety Authority (EFSA) issued an opinion on 26 and 27 November 2003 on the process of High Pressure Hydrolysis Biogas (HPHB) providing guidance on the possibilities to use this process and on its risks for the disposal of Category 1 material.
Five processes may, therefore, be approved as alternative means for the disposal and/or uses of animal by-products in line with the SSC opinions, in addition to those processing methods already provided for by Regulation (EC) No 1774/2002. It is also appropriate to lay down the conditions for the use of those processes.
The Commission has asked some of the applicants for approval of the processes to submit further information regarding the safety of their processes for the treatment and disposal of Category 1 material. That information is to be forwarded to the European Food Safety Authority for evaluation in due course.
Pending that evaluation, and considering current SSC opinions that tallow is safe as regards TSE, especially if it is pressure-cooked and filtered to remove insoluble impurities, it is appropriate to approve one of the processes, which processes animal fat into biodiesel, also for treatment and disposal, under strict conditions, of most Category 1 material, except for the most risky. In that case, it should be made clear that the treatment and disposal may include the recovery of bioenergy.
The approval and the operation of such alternative means should be without prejudice to other applicable EU legislation, in particular environmental legislation, and therefore the operating conditions established in this Regulation should, where applicable, be implemented according to Article 6 paragraph 4 of Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000(2) on the incineration of waste.
For processes approved for the treatment of Category 1 animal by-products, and as a surveillance measure complementary to the regular monitoring of processing parameters, the efficacy of the process, together with its safety with regard to animal and public health, should be demonstrated to the competent authorities by testing in a pilot plant during the first two years following the implementation of the process within each Member State concerned.
It is appropriate to amend Annex VI, Chapters II and III of Regulation (EC) No 1774/2002 as a consequence of approving the transformation of Category 1 animal by-products.
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 Treatment and disposal of Category 1 material
1.
2.
The competent authority may authorise the use of other process parameters for the stage of the biodiesel production process referred to in Annex IV, point 1(b)(i), and for the stage of the process of combustion of animal fat in a thermal boiler referred to in Annex VI, point 1(c)(i), if these parameters provide for an equivalent reduction of risks for public and animal health.
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:
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alkaline hydrolysis process as defined in Annex I;
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high pressure high temperature hydrolysis process as defined in Annex II;
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high pressure hydrolysis biogas process as defined in Annex III;
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biodiesel production process as defined in Annex IV;
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Brookes gasification process as defined in Annex V; and
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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:
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the biodiesel production process as defined in Annex IV, point 1(b)(i); and
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the process of combustion of animal fat in a thermal boiler as defined in Annex VI, point 1(c)(i).
Article 3 Conditions for implementing the processes defined in the Annexes
The competent authority shall approve the plants which use one of the processes described in the Annexes once it has authorised the process, if the plant complies with the technical specifications and parameters in the relevant Annex, and with the conditions laid down in Regulation (EC) No 1774/2002, except for the technical specifications and parameters laid down in that Regulation for other processes. For this purpose the person responsible for the plant shall demonstrate to the competent authority that all technical specifications and parameters established in the relevant Annex are met.
Article 4 Marking and further disposal or use of resulting materials
1.
Materials resulting from the processing of Category 1 and 2 materials, except biodiesel produced in accordance with Annex IV, shall be permanently marked in accordance with points 10 to 13 of Chapter I of Annex VI to Regulation (EC) No 1774/2002.
2.
Materials resulting from the treatment of Category 1 material shall be disposed of by at least one of the following methods:
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incineration or co-incineration in accordance with the provisions of Directive 2000/76/EC;
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burial in a landfill for which a permit has been issued in accordance with Council Directive 1999/31/EC;
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further transformation in a biogas plant and disposal of the digestion residues as provided for in points (a) or (b); or
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in the case of biodiesel produced in accordance with Annex IV, combustion as a fuel.
3.
Materials resulting from the treatment of Category 2 or 3 materials shall be:
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disposed of as provided for in paragraph 2 (a) or (b);
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further processed into fat derivatives for the uses referred to in Article 5(2)(b)(ii) of Regulation (EC) No 1774/2002, without the prior use of processing methods 1 to 5;
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used, transformed or disposed of directly as provided for in Article 5(2)(c)(i), (ii) and (iii) of Regulation (EC) No 1774/2002, without the prior use of processing method 1;
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in the case of materials other than biodiesel resulting from the biodiesel production process as defined in Annex IV, used for the production of technical products; or
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in the case of biodiesel produced in accordance with Annex IV, used as provided for in paragraph 2 (d).
4.
Any resulting waste, such as sludge, filter contents, ash and digestion residues, derived from the production process, shall be disposed of as provided for in paragraph 2, points (a) or (b).
5.
However, animal by-products resulting from the treatment of material in accordance with Annex IV may be used for the purposes laid down in this Annex.