Commission Regulation (EC) No 208/2006 of  7 February 2006  amending Annexes VI and VIII to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards processing standards for biogas and composting plants and requirements for manure   (Text with EEA relevance)
Date: 2006-02-07
Institutions: European Commission
Subjects: animal product, biogas, health control, health risk, organic fertiliser, technical standard, waste recycling

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COMMISSION REGULATION (EC) No 208/2006

of 7 February 2006

amending Annexes VI and VIII to Regulation (EC) No 1774/2002 of the European Parliament and of
the Council as regards processing standards for biogas and composting plants and requirements for
manure

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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
32(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 1774/2002 provides for measures to
ensure that manure and products derived there from are
used or disposed of in such a way as not to pose a risk
to public or animal health.

II of Annex VI

to Regulation (EC) No
Chapter
1774/2002 sets out
the
specific
approval of biogas and composting plants using animal
by-products.

requirements

for

Following the opinion of
the European Food Safety
Authority (EFSA) of 7 September 2005 on the safety
vis-à-vis biological
risks of biogas and composting
treatment standards of animal by-products, it is appro-
priate to amend Chapter II of Annex VI to Regulation
(EC) No 1774/2002 by allowing authorisation of other
process parameters.

Chapter
1774/2002

III of Annex VIII

sets

out

to Regulation (EC) No
for manure,

requirements

processed manure and processed manure products and
lays down the processing and control parameters manure
has to undergo to fulfil the requirements for processed
manure and processed manure products.

Following the opinion of EFSA of 7 September 2005 on
the biological safety of heat treatment of manure, it is
appropriate to amend the relevant
requirements of
Chapter III of Annex VIII to take account of that opinion.

Regulation (EC) No 1774/2002 should therefore be
amended accordingly.

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

opinion

the

the

of

(5)

(6)

(7)

HAS ADOPTED THIS REGULATION:

Article 1

Annexes VI and VIII to Regulation (EC) No 1774/2002 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.

It shall apply from 1 January 2006. However, the requirements
in Annex VI, chapter II, point C(13a) and in Annex VIII, chapter
III, point (II)(A)(5)(c) to Regulation (EC) No 1774/2002 shall
apply from 1 January 2007.

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

Done at Brussels, 7 February 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 416/2005 (OJ L 66, 12.3.2005,
p. 10).

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Annexes VI and VIII to Regulation (EC) No 1774/2002 are amended as follows:

ANNEX

1. In Annex VI, Chapter II is amended as follows:

(a) Points A(1) and (2) are replaced by the following:

‘1. A biogas plant must be equipped with:

(a) a pasteurisation/hygienisation unit, which cannot be by-passed, with:

(i) installations for monitoring temperature against time;

(ii) recording devices to record continuously the results of the monitoring measurements referred to in (i);

and

(iii) an adequate safety system to prevent insufficient heating;

(b) adequate facilities for the cleaning and disinfecting of vehicles and containers upon leaving the biogas

plant.

However, a pasteurisation/hygienisation unit shall not be mandatory for biogas plants that transform only:

(i) animal by-products that have undergone processing Method 1;

(ii) Category 3 material that has undergone pasteurisation/hygienisation elsewhere; or

(iii) animal by-products which may be used as raw material without processing.

If the biogas plant is located on premises where farmed animals are kept and does not only use manure
which accrues from those animals, the plant shall be located at an adequate distance from the area where
such animals are kept and there must be, in any case, total physical separation between that plant and
those animals and their feed and bedding, with fencing where necessary.

2. A composting plant must be equipped with:

(a) a closed composting reactor, which cannot be by-passed, with:

(i) installations for monitoring temperature against time;

(ii) recording devices

to record, where appropriate continuously,

the results of

the monitoring

measurements referred to in (i); and

(iii) an adequate safety system to prevent insufficient heating;

(b) adequate facilities for cleaning and disinfecting of vehicles and containers transporting untreated animal by-

products.

However, other types of composting systems may be allowed provided they:

(i) ensure adequate measures to control vermin;

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(ii) are managed in such a way that all the material

in the system achieves the required time and

temperature parameters, including, where appropriate, continuous monitoring of the parameters;

(iii) comply with all other requirements of this Regulation.

If the composting plant is located on premises where farmed animals are kept and does not only use
manure which accrues from those animals, the composting plant shall be located at an adequate distance
from the area where animals are kept and there must, in any case, be total physical separation between
that composting plant and the animals and their feed and bedding, with fencing where necessary.’

(b) Point B(11) is replaced by the following:

‘11. Digestion residues and compost must be handled and stored at the biogas respective composting plant in

such way as to prevent recontamination.’

(c) Point C(12) is replaced by the following:

‘12. Category 3 material used as raw material in a biogas plant equipped with a pasteurisation/hygienisation unit

must be submitted to the following minimum requirements:

(a) maximum particle size before entering the unit: 12 mm;

(b) minimum temperature in all material in the unit: 70 °C; and

(c) minimum time in the unit without interruption: 60 minutes.

However, category 3 milk, colostrums and milk products may be used without pasteurisation/hygienisation
as raw material in a biogas plant, if the competent authority does not consider them to present a risk of
spreading any serious transmissible disease.’

(d) Point C(13) is replaced by the following:

‘13. Category 3 material used as raw material

in a composting plant must be submitted to the following

minimum requirements:

(a) maximum particle size before entering the composting reactor: 12 mm;

(b) minimum temperature in all material in the reactor: 70 °C; and

(c) minimum time in the reactor at 70 °C (all material): 60 minutes.’

(e) The following Point C(13a) is inserted:

‘13a. However, the competent authority may authorise the use of other standardised process parameters provided
an applicant demonstrates that such parameters ensure minimising of biological risks. That demonstration
shall include a validation, which shall be carried out in accordance with points (a) to (f):

(a)

Identification and analysis of possible hazards, including the impact of input material, based on a full
definition of the processing conditions.

(b) A risk assessment, which evaluates how the specific processing conditions referred to in (a) are achieved

in practice under normal and atypical situations.

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(c) Validation of the intended process by measuring the reduction of viability/infectivity of:

(i) endogenous indicator organisms during the process, where the indicator is:

— consistently present in the raw material in high numbers,

— not less heat resistant to the lethal aspects of the treatment process, but also not significantly

more resistant than the pathogens for which it is being used to monitor,

— relatively easy to quantify and relatively easy to identify and to confirm;

or

(ii) a well-characterised test organism or virus, during exposure, introduced in a suitable test body into

the starting material.

(d) The validation of the intended process referred to in (c) must demonstrate that the process achieves the

following overall risk reduction:

(i) for thermal and chemical processes by:

— reduction of 5 log10 of Enterococcus faecalis or Salmonella Senftenberg (775W, H2S negative),

— reduction of infectivity titre of thermo resistant viruses such as parvovirus by at least 3 log10,

whenever they are identified as a relevant hazard;

and

(ii) as regards chemical processes also by:

— reduction of resistant parasites such as eggs of ascaris sp. by at least 99,9 % (3 log10) of viable

stages.

(e) Designing a complete control programme including procedures for monitoring the functioning of the

process referred to in (c).

(f) Measures ensuring continuous monitoring and supervision of the relevant process parameters fixed in

the control programme when operating the plant.

Details on the relevant process parameters used in a biogas or composting plant as well as other critical
control points must be recorded and maintained so that the owner, operator or their representative and
the competent authority can monitor the operation of the plant. Records must be made available to the
competent authority on request.

Information relating to a process authorised under this point must be made available to the Commission
on request.’

(f)

In point C(14), point (b) shall be replaced by the following:

‘(b) considers that the residues or compost are unprocessed material.’

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(g) Point D(15) is replaced by the following:

‘15. Representative samples of the digestion residues or compost taken during or immediately after processing at
the biogas or composting plant in order to monitor the process must comply with the following standards:

Escherichia coli: n = 5, c = 1, m = 1 000, M = 5 000 in 1 g;

or

Enterococaceae: n = 5, c = 1, m = 1 000, M = 5 000 in 1 g;

and

Representative samples of the digestion residues or compost taken during or on withdrawal from storage at
the biogas or composting plant must comply with the following standards:

Salmonella: absence in 25 g: n = 5; c = 0; m = 0; M = 0

where:

n = number of samples to be tested;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria

in all samples does not exceed m;

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of

bacteria in one or more samples is M or more; and

c = number of samples the bacterial count of which may be between m and M, the sample still being

considered acceptable if the bacterial count of the other samples is m or less.

Digestion residues or compost, which does not comply with the requirements set out in this Chapter shall be
reprocessed, in the case of Salmonella handled or disposed of in accordance with the instructions of the
competent authority.’

2. Annex VIII, Chapter III, Point II.A.(5) is replaced by the following:

‘5. The placing on the market of processed manure and processed manure products shall be subject to the following

conditions set out in points (a) to (e):

(a) They must come from a technical plant, a biogas plant or a composting plant approved by the competent

authority in accordance with this Regulation.

(b) They must have been subjected to a heat treatment process of at least 70 °C for at least 60 minutes and they

must have been subjected to reduction in spore-forming bacteria and toxic formation.

(c) However, the competent authority may authorise the use of other standardised process parameters than those
described in (b) provided an applicant demonstrates that such parameters ensure minimising of biological risks.
This demonstration shall include a validation, which shall be carried out as follows:

(i) Identification and analysis of possible hazards including the impact of input material, based on a full
the processing conditions, and a risk assessment, which evaluates how the specific

definition of
processing conditions are achieved in practice under normal and atypical situations.

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(ii) Validation of the intended process

(ii-1) by measuring the reduction of viability/infectivity of endogenous indicator organisms during the process,

where the indicator is:

— consistently present in the raw material in high numbers,

— not less heat resistant to the lethal aspects of the treatment process, but also not significantly more

resistant than the pathogens for which it is being used to monitor,

— relatively easy to quantify and relatively easy to identify and confirm;

or

(ii-2) by measuring the reduction of viability/infectivity, during exposure, of a well-characterised test organism

or virus introduced in a suitable test body into the starting material.

(iii) The validation referred to in point (ii) must demonstrate that the process achieves the following overall

risk reduction:

— for thermal and chemical processes by reduction of Enterococcus faecalis by at least 5 log10 and by
reduction of infectivity titre of thermo resistant viruses such as parvovirus, where they are identified as
a relevant hazard, by at least 3 log10,

— for chemical processes also by reduction of resistant parasites such as eggs of ascaris sp. by at least

99,9 % (3 log10) of viable stages.

(iv) Designing a complete control programme including procedures for monitoring the process.

(v) Measures ensuring continuous monitoring and supervision of the relevant process parameters fixed in

the control programme when operating the plant.

Details on the relevant process parameters used in a plant as well as other critical control points must be
recorded and maintained so that the owner, operator or their representative and the competent authority can
monitor the operation of the plant. Records must be made available to the competent authority on request.

Information relating to a process authorised under this point must be made available to the Commission on
request.

(d) Representative samples of the manure taken during or immediately after processing at the plant in order to

monitor the process must comply with the following standards:

Escherichia coli: n = 5, c = 5, m = 0, M = 1 000 in 1 g;

or

Enterococaceae: n = 5, c = 5, m = 0, M = 1 000 in 1 g;

and

Representative samples of the manure taken during or on withdrawal from storage at the technical, biogas or
composting plant must comply with the following standards:

Salmonella: absence in 25 g: n = 5; c = 0; m = 0; M = 0

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where:

n = number of samples to be tested;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria

in all samples does not exceed m;

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of

bacteria in one or more samples is M or more; and

c = number of samples the bacterial count of which may be between m and M, the sample still being

considered acceptable if the bacterial count of the other samples is m or less.

Processed manure or processed manure products not complying with the above requirements shall be regarded
as unprocessed;

(e) They must be stored in such a way that once processed contamination or secondary infection and dampness is

minimised. They must therefore be stored in:

(i) well-sealed and insulated silos, or

(ii) properly sealed packs (plastic bags or “big bags”).’