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 fatsText with EEA relevance
Date: 2005-01-19
Institutions: European Commission
Subjects: agricultural by-product, animal fats, animal product, biogas, food safety, health risk, human nutrition, processed foodstuff, waste management

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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,

(6)

Having regard to the Treaty
Community,

establishing the European

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:

(1)

(2)

(3)

(4)

(5)

Regulation (EC) No 1774/2002 provides
rules
concerning the means of disposal and uses of animal
by-products. It also provides for the possibility for addi-
tional means of disposal and uses of animal by-products
to be approved following consultation of the appropriate
scientific committee.

for

(SSC)

The Scientific Steering Committee
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.

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 668/2004 (OJ L 112, 19.4.2004,
p. 1).

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.

it

is appropriate to approve one of

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,
the
processes, which processes animal
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.

fat

in particular

environmental

The approval and the operation of such alternative means
should be without prejudice to other applicable EU legis-
and
lation,
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
Council of 4 December 2000 (2) on the incineration of
waste.

the European Parliament and of

legislation,

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 imple-
mentation 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
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(7)

(8)

(9)

(10)

(11)

(2) OJ L 332, 28.12.2000, p. 91.

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HAS ADOPTED THIS REGULATION:

Article 1

Treatment and disposal of Category 1 material

1.
The processes of alkaline hydrolysis as defined in Annex I
and of high pressure hydrolysis biogas as defined in Annex III
are approved and may be authorised by the competent
authority for the treatment and disposal of Category 1 material.

The process of biodiesel production as defined in Annex
2.
IV is approved and may be authorised by the competent
the treatment and disposal of Category 1
authority for
material, except
for material referred to in Article 4(1)(a)(i)
and (ii) of Regulation (EC) No 1774/2002.

However, material derived from animals referred to in Article
4(1)(a)(ii) may be used for this process provided that:

(a)

the animals were below 24 months of age at the time they
were killed; or

(b) the animals were subjected to laboratory testing for the
to Regulation (EC) No
the

presence of a TSE pursuant
999/2001 of
and of
Council (1) and the result of the testing was negative.

the European Parliament

and with the conditions laid down in Regulation (EC) No
1774/2002, except for the technical specifications and para-
meters laid down in that Regulation for other processes. For
this purpose the person responsible for the plant shall demon-
strate 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

Resulting materials shall be permanently marked, where
in accordance with Annex VI,

1.
technically possible with smell
Chapter I, point 8 of Regulation (EC) No 1774/2002.

However, in the case where the by-products being processed are
exclusively Category 3 material, and where the resulting
materials are not
intended for disposal as waste, no such
marking shall be required.

2. Materials resulting from the treatment of Category 1
material shall be disposed of as waste by:

(a)

incineration or co-incineration in accordance with the
provisions of Directive 2000/76/EC on the incineration of
waste;

(b) burial

in a landfill approved under Council Directive

1999/31/EC (2) on the landfill of waste; or

The competent authority may also authorise this process for the
treatment and disposal of any Category 1 processed animal fat.

(c)

further transformation in a biogas plant and disposal of the
digestion residues as provided for in points (a) or (b).

Article 2

3. Materials resulting from the treatment of Category 2 or 3
materials shall be:

Treatment and use or disposal of Categories 2 or 3 material

The processes of alkaline hydrolysis, high pressure high
temperature hydrolysis, high pressure hydrolysis biogas,
biodiesel production and Brookes gasification as defined in
Annexes I to V respectively are approved and may be authorised
by the competent authority for the treatment and use or
disposal of Categories 2 or 3 material.

Article 3

Conditions for implementing the processes defined in
Annexes I to V

the processes described in Annexes I

The competent authority shall approve the plants which use one
to V once it has
of
authorised the process,
complies with the
technical specifications and parameters in the relevant Annex,

the plant

if

(a) disposed of as waste as provided for in paragraph 2;

(b) further processed into fat derivatives for the uses mentioned
in Article 5(2)(b)(ii) of Regulation (EC) No 1774/2002,
without the prior use of processing methods 1 to 5; or

(c) used, transformed or disposed of directly as provided for in
(ii) and (iii) of Regulation (EC) No
Article 5(2)(c)(i),
1774/2002, without the prior use of processing method 1.

Any resulting waste, such as sludge, filter contents, ash
4.
and digestion residues, derived from the production process,
shall be disposed of as provided for in paragraph 2, points (a)
or (b).

(1) OJ L 147, 31.5.2001, p. 1.

(2) OJ L 182, 16.7.1999, p. 1.

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Article 5

Article 6

Additional surveillance on initial implementation

Amendment of Annex VI of Regulation (EC) No 1774/2002

1.
The following provisions shall apply for the first two years
of implementation of the following processes in each Member
State, for the treatment of animal by-products referred to in
Article 4 of Regulation (EC) No 1774/2002:

(a) alkaline hydrolysis as defined in Annex I;

(b) high pressure hydrolysis biogas as defined in Annex III; and

(c) biodiesel production as defined in Annex IV.

The operator or supplier of the process shall designate a
2.
pilot plant in each Member State where, at least annually, tests
shall be undertaken to reconfirm the efficacy of the process
with regard to animal and public health.

3.

The competent authority shall ensure that:

(a) suitable tests are applied in the pilot plant to the materials
derived from the treatment steps, such as the liquid and
solid residues, and any gas generated during the process;
and

(b) the official control of the pilot plant include a monthly
inspection of the plant and a verification of the processing
parameters and conditions applied.

At the end of each of the two years the competent authority
shall report to the Commission the results of the surveillance,
and any practical operating difficulties encountered.

Chapters
1774/2002 shall be amended as follows:

II and III of Annex VI of Regulation (EC) No

1. In Chapter II, point B, at the end of number 4, the following

resulting materials

sentence is added:
‘However,
from the processing of
Category 1 material may be transformed in a biogas plant,
provided that the processing was done pursuant to an alter-
native method approved in accordance with Article 4(2)(e)
and, except as otherwise specified, the biogas production is
part of that alternative method and the resulting material is
disposed of in accordance with the conditions laid down for
the alternative method.’

2. At the end of Chapter III, the following sentence is added:

‘However, other processes may be used for
further
processing of
fats derived from Category 1
material, provided these processes are approved as alternative
method in accordance with Article 4(2)(e).’

animal

Article 7

Entry into force and applicability

This Regulation shall enter into force on the third day following
the European
that of
Union.

its publication in the Official

Journal of

It shall apply no later than 1 January 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 January 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

ALKALINE HYDROLYSIS PROCESS

1. Alkaline hydrolysis means treatment of animal by-products under the following conditions:

(a) Either a sodium hydroxide (NaOH) or potassium hydroxide (KOH) solution (or a combination thereof) is used in
an amount that assures approximate molar equivalency to the weight, type and composition of the animal by-
products to be digested.

In the case of high fat in the animal by-products that neutralises the base, the added base is adjusted to the current
fat content of the material.

(b) The animal by-products and alkali mixture are heated to a core temperature of at least 150 °C and at a pressure

(absolute) of at least 4 bars for at least:

(i) three hours without interruption;

(ii) six hours without interruption in case of treatment of animal by-products referred to in Article 4(1)(a)(i) and
(ii) of Regulation (EC) No 1774/2002. However, material derived from animals referred to in Article 4(1)(a)(ii)
may be processed in accordance with point 1(b)(i) provided that:

— the animals were below 24 months of age at the time they were killed, or

— the animals were subjected to laboratory testing for the presence of a TSE pursuant to Regulation (EC) No

999/2001 and the result of the testing was negative, or

(iii) one hour without interruption in case of animal by-products consisting exclusively of fish or of poultry

materials.

(c) The process is carried out in a batch and the material in the vessel is constantly mixed; and

(d) The animal by-products are treated in such a manner that the time-temperature-pressure requirements are achieved

at the same time.

2. Animal by-products are placed in a steel alloy container. The measured amount of alkali is added either in solid form
or as a solution as referred to in point 1(a). The vessel is closed and the content heated in accordance with point 1(b).
The physical energy generated by a constant pumping action continually circulates the liquid material present in the
vessel thereby aiding the digestion process until the tissues are dissolved and bones and teeth softened.

3. Following the treatment described above, resulting materials may be transformed in a biogas plant provided that:

(a) Transformation in a biogas plant of material referred to in Article 4(1)(a) and (b) of Regulation (EC) No
1774/2002 and products derived therefrom takes place on the same site and in a closed system as the process
described under points 1 and 2 above;

(b) An appropriate gas clean-up system is in place to exclude contamination of the biogas with protein residues;

(c) The biogas is combusted rapidly at a minimum of 900 °C, and followed by rapid chilling (‘quenching’).

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ANNEX II

HIGH PRESSURE HIGH TEMPERATURE HYDROLYSIS PROCESS

1. High pressure high temperature hydrolysis process means treatment of animal by-products under the following

conditions:

(a) The animal by-products are heated to a core temperature of at least 180 °C for at least 40 minutes without
interruption at a pressure (absolute) of at least 12 bar, heated by indirect steam application to the biolytic reactor;

(b) The process is carried out in a batch and the material in the vessel is constantly mixed; and

(c) The animal by-products are treated in such a manner that the time-temperature-pressure requirements are achieved

at the same time.

2. The basis of the technology is a high pressure, high temperature steam reactor. At these elevated pressures and
temperatures the phenomena of hydrolysis occurs which fractures long chain molecules of the organic material into
smaller fragments.

Animal by-products, including whole animal carcases are placed in a container (‘biolytic reactor’). The vessel is closed
and the content heated in accordance with point 1(a). In the dehydration cycle the steam water is condensed and may
be used for other purposes or may be discarded. Each cycle for one reactor takes approximately four hours.

ANNEX III

1. High pressure hydrolysis biogas process means treatment of animal by-products under the following conditions:

HIGH PRESSURE HYDROLYSIS BIOGAS PROCESS

(a) The animal by-products are first processed using processing method 1 in a processing plant approved in

accordance with Regulation (EC) No 1774/2002;

(b) Following the above process, the defatted materials are treated at a temperature of at least 220 °C for at least 20
minutes at a pressure (absolute) of at least 25 bar, heated in a two-step procedure, first by direct steam injection,
secondly indirect in a coaxial heat exchanger;

(c) The process is carried out in a batch or continuous system and the material is constantly mixed;

(d) The animal by-products are treated in such a manner that the time-temperature-pressure requirements are achieved

at the same time; and

(e) The resulting material is then mixed with water and anaerobically fermented (biogas transformation) in a biogas

reactor.

2. In case of treatment of Category 1 animal by-products:

(a) The entire process takes place on the same site and in a closed system;

(b) The biogas produced during the process is combusted rapidly in the same plant at a minimum of 900 °C followed
by rapid chilling (‘quenching’), and an appropriate gas clean-up system is in place to exclude contamination with
protein residues of the biogas or the gases derived from its burning.

3. The process is designed to process material coming out of a conventional rendering plant using processing method 1.
This material is treated in accordance with point (1) (b), subsequently mixed with water and submitted to biogas
fermentation.

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ANNEX IV

BIODIESEL PRODUCTION PROCESS

1. Biodiesel production means treatment of the fat fraction of animal by-products (animal fat) under the following

conditions:

(a) The fat fraction of animal by-products is first processed using:

(i) processing method 1 as referred to in Annex V, Chapter III of Regulation (EC) No 1774/2002 in case of

Category 1 or 2 materials; and

(ii) any of the processing methods 1 to 5 or 7 or, in the case of material derived from fish, method 6 as referred

to in Annex V, Chapter III of Regulation (EC) No 1774/2002 in case of Category 3 materials;

(b) The processed fat is separated from the protein and insoluble impurities are removed to a level not exceeding
0,15 % in weight, and subsequently submitted to esterfication and transesterfication. However, esterfication is not
required for Category 3 processed fat. For esterfication the pH is reduced to less than 1 by adding sulphuric acid
(H2SO4; 1,2-2 molar) or an equivalent acid and the mixture is heated to 72 °C for 2 hours during which it is
intensely mixed. Transesterfication shall be carried out by increasing the pH to about 14 with 15 % potassium
hydroxide (KOH; 1-3 molar) or with an equivalent base at 35 °C to 50 °C for at least 15 to 30 minutes.
Transesterfication shall be carried out twice under the conditions described above using a new base solution.
This process is followed by refinement of the products including vacuum distillation at 150 °C, leading to biodiesel;

(c)

In case of biodiesel resulting from the treatment of Category 1 material an appropriate gas clean-up system shall
be in place to exclude emission of possible non-combusted protein residues when the biodiesel is combusted.

2. Animal fat is processed for the production of biodiesel consisting of methyl esters of fatty acids. This is achieved by
submitting the fat to esterfication and/or transesterfication. Subsequent refinement of the products including vacuum
distillation leads to biodiesel, which is used as fuel for combustion.

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ANNEX V

BROOKES GASIFICATION PROCESS

1. Brookes gasification process means treatment of animal by-products under the following conditions:

(a) The afterburner chamber is warmed up using natural gas.

(b) The animal by-products are loaded into the primary chamber of the gasificator and the door is closed. The primary
chamber has no burners and is heated instead by the transfer of heat by conduction from the afterburner, which is
underneath the primary chamber. The only air admitted to the primary chamber is via three inlet valves mounted
on the main door to enhance the efficiency of the process.

(c) The animal by-products are volatilised into complex hydrocarbons and the resultant gases pass from the primary
chamber via a narrow opening at the top of the back wall to the mixing and cracking zones, where they are
broken down into their constituent elements. Finally the gases pass into the afterburner chamber where they are
burned in the flame of a natural gas fired burner in the presence of excess air.

(d) Each process unit has two burners and two secondary air fans for back-up in case of burner or fan failure.
The secondary chamber is designed to give a minimum residence time of two seconds at a temperature of at least
950 oC under all conditions of combustion.

(e) On leaving the secondary chamber the exhaust gases pass through a barometric damper at the base of the stack,
which cools and dilutes them with ambient air, maintaining a constant pressure in the primary and secondary
chambers.

(f) The process is carried out over a 24-hour cycle, which includes loading, processing, cool down and ash removal.
At the end of the cycle the residual ash is removed from the primary chamber by a vacuum extraction system into
enclosed bags, which are then sealed before being transported off-site for disposal.

2. The process employs high temperature combustion in excess oxygen to oxidise organic matter to CO2, NO2 and H2O.
A batch process is used with a prolonged residence time for the animal by-products of around 24hrs. The source of
heat is a secondary chamber fired by natural gas, which is underneath the primary chamber (in which the tissue to be
processed is placed). The gases produced as a result of the combustion process enter the secondary chamber where
they are further oxidised. The gas stream has a minimum residence time of two seconds at a recommended
temperature of 950 degrees centigrade. Subsequently the gases pass through a ‘barometric damper’ where they are
mixed with ambient air.

3. The gasification of other material than animal by-products is not permitted.