EUROPEAN
COMMISSION
Brussels, XXX
SANCO/7118/2012 Rev. 5
(POOL/G2/2012/7118/7118R5-EN
CIS.doc)
[…](2012) XXX draft
COMMISSION REGULATION (EU) No …/..
of XXX
amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of
the European Parliament and of the Council laying down health rules as regards animal
by-products and derived products not intended for human consumption and
implementing Council Directive 97/78/EC as regards certain samples and items exempt
from veterinary checks at the border under that Directive
(Text with EEA relevance)
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COMMISSION REGULATION (EU) No …/..
of XXX
amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of
the European Parliament and of the Council laying down health rules as regards animal
by-products and derived products not intended for human consumption and
implementing Council Directive 97/78/EC as regards certain samples and items exempt
from veterinary checks at the border under that Directive
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the
Council of 21 October 2009 laying down health rules as regards animal by-products and
derived products not intended for human consumption and repealing Regulation (EC)
No 1774/2002 (Animal by-products Regulation)1, and in particular Article 21(6)(d),
Article 40(f) and Article 48(7)(b) thereof,
Whereas:
(1)
Regulation (EC) No 1069/2009 lays down public and animal health rules for animal
by-products and derived products, in order to prevent and minimise risks to public and
animal health arising from those products. It categorises those products into specific
categories which reflect the level of risk to public and animal health arising from those
products and provides for requirements on their safe use and disposal.
(2)
The European Food Safety Authority (EFSA) has assessed with reference to Article 20
of Regulation (EC) No 1069/2009 the “Biodiesel Process” as a method for safe
disposal of category 1 Animal by-Products (ABP)2, the Neste Oil application for a new
alternative method of disposal or use of Animal By-Products3 and the abiotic risks for
public and animal health of glycerine as co-product from the biodiesel production
from Category 1 animal by-products (ABP) and vegetable oils4 as safe methods for
processing of animal by-products. Based on those opinions the Commission declared
derived products arising from those methods as the end point in the manufacturing
chain of animal by-products.
1
OJ L 300, 14.11.2009, p. 1.
EFSA Journal (2004), 23, 1-3.
EFSA Journal 2010; 8(10):1825 [9 pp.].
EFSA Journal 2010; 8(12):1934 [22 pp.].
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(3)
In accordance with Article 40(f) of Regulation (EC) No 1069/2009, the Commission
may lay down conditions for the safe use of derived products which pose a risk to
public or animal health, taking into account the principles laid down in Articles 37, 38
and 39 of that Regulation on safe sourcing, treatment and end uses, even more where
all elements and instruments to be applied have already been assessed by EFSA and
recognised as safe methods for the disposal and use of animal by-products and derived
products and, in addition, mechanisms provided by the existing legislation on animal
by-products are applied.
(4)
Commission Regulation (EU) No 142/20115, lays down implementing rules for
Regulation (EC) No 1069/2009, including rules on placing on the market, including
import, and technical standards for processing and safe use of rendered fats.
(5)
Annex IV to Regulation (EU) No 142/2011 lays down standard processing method and
alternative processing method which may be applicable for processing of certain
animal by-products. Alternative processing methods authorise use of Category 1 and 2
render fats processed with methods 1 in the production of biodiesel or renewable fuels.
(6)
Following the introduction of new rules on the use of materials resulting from
biodiesel production into Annex IV to Regulation (EU) No 142/2011 by [Regulation
(EU) No …/…6], those materials may now be transformed into biogas and the
digestion residues from that transformation applied to land, provided the rendered fat
of Category 1 and 2 was processed with method 1.
(7)
Biodiesel and renewable fuels may be produced from rendered fats of Category 1 and
2 processed by methods 2 to 5 or 7, provided the risks to public and animal health are
controlled in accordance with Article 36 of Regulation (EC) No 1069/2009 by safe
end uses. However such biodiesel or renewable fuels as well as materials resulting
from their production cannot be declared as the end point in the manufacturing chain.
Materials resulting from the production of biodiesel or renewable fuels are to be
disposed as waste, unless processed with method 1 and transformed into biogas or
used for technical purposes authorised for Category 1 material.
(8)
Processing into biodiesel or renewable fuels destined for combustion of rendered fats
of Category 1 or 2 materials processed by methods 7 cannot pose a higher risk than the
use, in accordance with Article 12 and 13 of Regulation (EC) No 1069/2009, of
rendered fats of Category 1 or 2 materials as fuel for combustion without prior
processing. It is therefore appropriate to introduce a derogation as regards the
processing method and the source material under the condition that the resulting
biodiesel and renewable fuels are blended in mineral diesel intended for combustion
and the final materials resulting from the production of those fat derivatives are
disposed as waste unless processed with method 1 to be subsequently transformed into
biogas or used for technical purposes applicable for Category 1 or 2 materials. Annex
IV should therefore be amended accordingly.
(9)
Annex XIII to Regulation (EU) No 142/2011 lays down animal health requirements
for placing on the market of certain derived products. In order to be placed on the
market and in accordance with Chapter II of Annex IV to Regulation (EU) No
5
OJ L 54, 26.2.2011, p. 1.
COM(2012) 7188.
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142/2011, Category 1 and 2 materials, including rendered fats, are to be processed by
one of the methods 1 to 5 set out in Chapter III of that Annex.
(10)
With reference to Article 7 of Regulation (EC) No 999/2001 of the European
Parliament and of the Council of 22 May 2001 laying down rules for the prevention,
control and eradication of certain transmissible spongiform encephalopathies7,
Member States are to carry out all necessary measures to prevent the introduction of
prohibited material into the production of food, feed or organic fertilisers and soil
improvers. In order to prevent their use in the feed chain of farmed animals, rendered
fats of Category 1 and 2 materials are to be channelled from the rendering plant or, in
case of imports into the Union, from the border inspection post to the biodiesel or
renewable fuel plant for further processing.
(11)
Certain risks posed by rendered fats of Category 1 or 2 material processed with
method 2 to 5 or 7 are significantly reduced, provided such fats undergo purification in
such a way that the maximum level of remaining total insoluble impurities does not
exceed 0,15 % in weight, they are marked with glyceroltriheptanoate (GTH) and are
channelled to a processing plant for further processing with a combination of
temperature, time and pressure comparable to method 1 into biodiesel or renewable
fuels. It is therefore appropriate to introduce derogation as regards the processing
method and the source material under the condition that those rendered fats are
channelled to the processing plants. Annex XIII should therefore be amended
accordingly.
(12)
Annex XIV lays down requirements for the import into the Union of animal byproducts and derived products. To provide standards for the import of rendered fats of
Category 1 and 2 processed with method 7, this Annex should be amended
accordingly.
(13)
Regulation (EU) No 142/2011 should therefore be amended accordingly.
(14)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on the Food Chain and Animal Health, and neither the European
Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION:
Article 1
Annexes IV, XIII and XIV to Regulation (EU) No 142/2011 are amended in accordance with
the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
It shall apply from 15 March 2013.
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OJ L 147, 31.5.2001, p. 1.
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This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
José Manuel BARROSO
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ANNEX
Annexes IV, XIII and XIV to Regulation (EU) No 142/2011 are amended as follows:
(1)
In Annex IV, Chapter IV, Section 3 is amended as follows:
(a)
In point 1, the following point is added:
"(c) Biodiesel produced from rendered fats derived from Category 1 or
Category 2 materials using, by way of derogation from point D(2)(a)(i)
of Section 2, processing methods 2 to 5 or 7 as set out in Chapter III, and
renewable fuels produced, by way of derogation from point J(1)(b) of
Section 2, from Category 1 or Category 2 materials using, by way of
derogation from point J(1)(a)(i) of Section 2, methods 2 to 5 or 7 as set
out in Chapter III, shall be dispatched to a mineral oil company for
blending in mineral diesel."
(b)
Point 2(d) is replaced by the following:
"(d) the lime treated mixture of pig and poultry manure may be applied to
land as processed manure;
(e)
point 1(c) shall be:
(i)
disposed of either in accordance with Article 12(a) or (b) or in
accordance with Article 13(a) or (b) of Regulation (EC) No
1069/2009;
(ii)
used either in accordance with Article 12(e) or in accordance with
Article 13(h) of Regulation (EC) No 1069/2009; or
(iii) processed using processing method 1 for subsequent use either in
accordance with Article 12(f) or in accordance with Article 13(d)
or (i) of Regulation (EC) No 1069/2009."
(2)
In Annex XIII, Chapter X, the following point is added:
"3.
(3)
By way of derogation from point 1, rendered fats derived from Category 1 or
Category 2 materials may be produced using processing method 7 as set out in
Chapter III of Annex IV, provided that they are transported in sealed closed
packaging directly from the processing plant producing the rendered fats to
another processing plant where they shall be processed into biodiesel or
renewable fuels in accordance with point 1(c) of Section 3 of Chapter IV of
Annex IV.".
In Annex XIV, Chapter II, Section 9, the point (b) is replaced by the following:
"(b) they have been processed using processing method 1 (pressure sterilisation), in
accordance with one of the other processing methods referred to in Chapter III
of Annex IV or in accordance with point 3 of Chapter X of Annex XIII;
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Third countries shall notify the Commission about the information at their
disposal under points 1 and 2 of processing method 7 in accordance with point
G of Chapter III of Annex IV in relation to an authorised processing method."
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