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24.11.2012 Official
Journal
of
the
European
Union
L
326/3
COMMISSION IMPLEMENTING REGULATION (EU) No 1097/2012
of 23 November 2012
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 as regards dispatch of animal by-products and derived products between Member
States
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
avoid unnecessary disruptions of the internal market in
the case of events which are linked to actual or potential
risks to public or animal health.
Having regard to the Treaty on the Functioning of the European
Union,
(4) Operators
must
ensure
that
activities
covered
by
the
scope of animal by-products legislation are registered
Having regard to Regulation (EC) No 1069/2009 of the
or approved. However, handling of small quantities of
European Parliament and of the Council of 21 October 2009
Categories 2 and 3 materials may present negligible
laying down health rules as regards animal by-products and
risk if they originate from areas where no transmissible
derived products not intended for human consumption and
disease to humans or animals has been notified. Member
repealing Regulation (EC) No 1774/2002 ( 1 ), and in particular
States should therefore be authorised to allow particular
Article 21(5)(a) and Articles 23(3) and 48(2) thereof,
activities without registration as provided for in Article 23
of Regulation (EC) No 1069/2009. Such a derogation
must be limited only to activities concerning the direct
Whereas:
supply of the products within the region to the final user,

on the local market or to local retail establishments.
(1) Regulation
(EC)
No
1069/2009
lays
down
public
and
animal health rules for animal by-products and derived
(5) Each
consignment
of
animal
by-products
or
derived
products, in order to prevent and minimise risks to
products to be traded between Member States is to be
public and animal health arising from those products.
accompanied by a commercial document. However, it is
It also provides rules for placing on the market of
necessary to amend and extend current requirements on
animal by-products and derived products.
the commercial document to ensure that it includes all
necessary information on the safe handling, treatment
and intended use or disposal of the concerned material.
(2) Commission Regulation (EU) No 142/2011 of
25 February 2011 implementing Regulation (EC) No
1069/2009 of the European Parliament and of the
(6) On
the
commercial
document
operators
must
specify
Council laying down health rules as regards animal by-
certain information on the consignment, in particular
products and derived products not intended for human
the category of animal by-products or derived products,
consumption and implementing Council Directive
nature of commodity and type of treatment. According
97/78/EC as regards certain samples and items exempt
to Article 3 of Regulation (EU) No 142/2011 there is no
from veterinary checks at the border under that Direc
need to issue a commercial document for derived
tive (
products which have been declared as the end point in

2 ), lays down implementing rules for Regulation (EC)
No 1069/2009, including rules on the registration of
the manufacturing chain. Also a reference to processing
operators, the content of commercial documents which
standards in Regulation (EC) No 853/2004 of the
accompany consignments of animal by-products and
European Parliament and of the Council ( 3 ) may be
derived products in trade between Member States and
removed. Annex VIII to Regulation (EU) No 142/2011
the layout of the notification form which must be
should therefore be amended.
provided for certain animal by-products and derived
products pursuant to Article 48(1) of Regulation (EC)
No 1069/2009.
(7) Several
animal
by-products
and
derived
products
referred
to in Article 48(1) of Regulation (EC) No 1069/2009
must be authorised in advance by the competent
(3) Pursuant
to
Regulation
(EC)
No
1069/2009,
operators
authority of the Member State of destination upon appli
are to ensure that animal by-products and derived
cation by the operator. Annex XVI to Regulation (EU) No
products are traceable at all stages of the chain of
142/2011 sets out a standard format for the authori
collecting, manufacturing, use and disposal, so as to
sation of the dispatch of animal by-products and
derived products to another Member State. That format
( 1 ) OJ L 300, 14.11.2009, p. 1.
( 2 ) OJ L 54, 26.2.2011, p. 1.
( 3 ) OJ L 139, 30.4.2004, p. 55.

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L 326/4
EN
Official Journal of the European Union
24.11.2012
should be amended to include information on the end
directly dispatched to a plant producing derived
date of validity of authorisations, the volume or mass of
products for uses outside the feed chain or to a plant
the consignment, the name and address of the consignor,
carrying out intermediate operations, under conditions
the origin of the animal by-products and the place of
which prevent the spreading of pathogenic agents;
destination of the consignment. Annex XVI to Regulation
(EU) No 142/2011 should therefore be amended.
(d) operators using small quantities of Categories 2 and 3
materials referred to in Articles 9 and 10 of Regulation
(8) Regulation
(EU)
No
142/2011
should
therefore
be
amended accordingly.
(EC) No 1069/2009 or of products derived therefrom,

for the purpose of direct supply of the products within
the region to the final user, on the local market or to
(9) The
measures
provided
for
in
this
Regulation
are
in
local retail establishments, if the competent authority
accordance with the opinion of the Standing
does not consider such activity to present a risk of
Committee on the Food Chain and Animal Health,
spreading any serious transmissible disease to humans
or animals; this point shall not apply where those
materials are used as feed for farmed animals other
HAS ADOPTED THIS REGULATION:
than fur animals.’;
Article 1
(2) Annexes VIII and XVI are amended in accordance with the
Regulation (EU) No 142/2011 is amended as follows:
text in the Annex to this Regulation.
(1) in Article 20, point (c) of paragraph 4 is replaced by the
following:
Article 2
This Regulation shall enter into force on the twentieth day
‘(c) operators transporting dry untreated wool and hair,
following that of its publication in the Official Journal of the
provided they are securely enclosed in packaging, and
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 November 2012.
For the Commission
The President
José Manuel BARROSO

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24.11.2012 Official
Journal
of
the
European
Union
L
326/5
ANNEX
The Annexes to Regulation (EU) No 142/2011 are amended as follows:
(1) in Annex VIII, Chapter III, the model commercial document is replaced by the following:

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L 326/6
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Official Journal of the European Union
24.11.2012
‘Commercial document
For the transport of animal by-products and derived products not intended for human consumption in accordance with
Regulation (EC) No 1069/2009 within the European Union

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24.11.2012 Official
Journal
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European
Union
L
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L 326/8
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Official Journal of the European Union
24.11.2012
(2) in Annex XVI, Chapter III, Section 10 is replaced by the following:
‘Section 10
Standard format for applications for certain authorisations in intra-Union trade
Operators shall apply to the competent authority of the Member State of destination for the authorisation of the
dispatch of animal by-products and derived products referred to in Article 48(1) of Regulation (EC) No 1069/2009 in
accordance with the following format:

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24.11.2012 Official
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European
Union
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L 326/10
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Official Journal of the European Union
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Document Outline

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