Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation   (Text with EEA relevance)
Date: 2006-12-22
Institutions: European Commission
Subjects: Union transit, animal product, by-product, health legislation, import, medical device, medical diagnosis

L 379/98

EN

Official Journal of the European Union

28.12.2006

COMMISSION REGULATION (EC) No 2007/2006

of 22 December 2006

implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as
regards the importation and transit of certain intermediate products derived from Category 3
in vitro diagnostics and laboratory
material

intended for technical uses in medical devices,

reagents and amending that Regulation

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1774/2002 of
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) and point 4 of Chapter IV(A) of Annex VIII thereof,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 1774/2002 provides that certain
animal
the
by-products may
Community for the production of
technical products
provided that they comply with that Regulation.

imported

into

be

Annex VIII to Regulation (EC) No 1774/2002 sets out
the requirements for the placing on the market of certain
technical products including starting materials to be used
for or in the production of technical products which may
include medical devices,
and
laboratory reagents.

in vitro diagnostics

However, certain Member States, trading partners and
operators have expressed concerns over the importation
of certain products sourced from Category 3 material
intended for the production of medical devices, in vitro
diagnostics and laboratory reagents (‘the intermediate
products’).
It is therefore necessary to clarify the im-
and to lay down specific
portation requirements
conditions for those intermediate products.

Although the intermediate products concerned may have
been subjected to preliminary processing,
the way in
which they are transported to the Community does not
make it possible to differentiate them from other types of
animal by-products intended for other technical uses,
except by taking into account their intended destination
and uses. The monitoring of their intended destination

(5)

(6)

(7)

and uses under other Community legislation should be
sufficient to ensure that they are not diverted into the
food and feed chains at a later stage, provided that risk-
appropriate channelling, recording and control measures
are put in place.

The placing on the market of the intermediate products
concerned should therefore be channelled in accordance
with Council Directive 97/78/EC of 18 December 1997
laying down the principles governing the organisation of
veterinary checks on products entering the Community
from third countries (2), and subjected to specific identi-
fication and control measures, in order to reduce the risk
of diversion into the food and feed chains and other
unintended uses.

regime provided for

Annex VIII to Regulation (EC) No 1774/2002 sets out
the requirements for
the placing on the market of
technical products. A comprehensive review and clarifi-
cation of that Annex is to be undertaken once the tran-
sitional
in that Regulation has
expired. It is therefore, appropriate to lay down in the
meantime the rules required for the importation of inter-
mediate products intended for technical uses in medical
devices, in vitro diagnostics and laboratory reagents in a
specific regulation complementing the rules already laid
down in that Annex.

than medical devices,

Until a full review and clarification has been undertaken,
it is necessary to clarify the scope of Chapters IV and XI
of Annex VIII to Regulation (EC) No 1774/2002 to take
into account this specific Regulation being laid down.
The rules set out in Chapter IV should concern blood
used for all technical purposes and blood products other
than the serum of equidae used for technical purposes
in vitro diagnostics or
other
laboratory reagents. The rules set out
in Chapter V
should continue to concern the serum of equidae
intended for any technical purposes,
including medical
devices, in vitro diagnostics or laboratory reagents, and
thus such rules do not need to be amended. The rules set
out in Chapter XI should concern the importation of
other non-processed animal by-products, which are not
covered by this Regulation, imported for any purposes,
in vitro diagnostics or
including medical devices,
laboratory reagents.

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 208/2006 (OJ L 36, 8.2.2006,
p. 25-31).

(2) OJ L 24, 30.1.1998, p. 9. Directive as last amended by Regulation
(EC) No 882/2004 of the European Parliament and of the Council
(OJ L 165, 30.4.2004, p. 1).

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Official Journal of the European Union

L 379/99

(8)

(9)

a

of

consequence

some
As
amendments need to be made to certain model health
certificates laid down in Annex X to Regulation (EC) No
1774/2002.

clarification,

such

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Scope

This Regulation shall apply to the importation and transit
through the Community of an ‘intermediate product’, as
defined in Article 2 of this Regulation.

Article 2

Definition

An ‘intermediate product’ means a product derived from
intended for the manufacture of medical
Category 3 material
devices, in vitro diagnostics or laboratory reagents, and whose
design,
transformation and manufacturing stages have been
sufficiently completed in order to be regarded as processed
products and to qualify the material for that purpose, except
for the fact that it requires some further handling or trans-
formation such as mixing, coating, assembling, packaging or
labelling to make it suitable for placing on the market or
putting into service in accordance with the Community legis-
lation applicable to the final products concerned.

Article 3

Importation

Member States shall authorise imports of
products that comply with the following conditions:

the intermediate

(ii) the name of the establishment of production; and

(iii) that the outer packaging of intermediate products is
labelled ‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/
LABORATORY REAGENTS ONLY’.

The commercial document must be in at least one of the
official
languages of the EU Member State in which the
inspection at the border inspection post shall be carried
the EU Member State of destination. These
out and of
Member States may allow other languages,
if necessary,
accompanied by an official translation.

(e)

they are accompanied by a declaration of the importer in
accordance with the model declaration set out in Annex II
to this Regulation. The declaration must be in at least one
of the official languages of the EU Member State in which
the inspection at the border inspection post shall be carried
the EU Member State of destination. These
out and of
if necessary,
Member States may allow other languages,
accompanied by an official translation.

Article 4

Checks, transport and labelling

1.
The intermediate products imported into the Community
shall be checked at the border inspection post of first entry in
accordance with Article 4 of Directive 97/78/EC and trans-
ported directly from the border inspection post of entry into
the Community either:

(a)

to a technical plant approved in accordance with Article 18
of Regulation (EC) No 1774/2002, where the intermediate
products shall be further mixed, used for coating, assembled,
packaged or labelled before they are placed on the market
or put into services in accordance with the Community
legislation applicable to the final product; or

(a)

they come from a third country listed as member of the
World Organisation for Animal Health (OIE)
in the OIE
Bulletin;

(b) to a Category 3 intermediate plant or

storage plant
approved in accordance with Article 10(3) or with Article
11 of Regulation (EC) No 1774/2002.

(b) they come from a plant registered or approved by the
competent authority of a third country referred to in
point (a) of this Article in accordance with the conditions
set out in Annex I to this Regulation;

(c)

they are derived exclusively from Category 3 material;

(d) each consignment must be accompanied by a commercial

document indicating:

(i) the country of origin,

2.
Intermediate products in transit through the Community
shall be transported in accordance with Article 11 of Directive
97/78/EC.

The official veterinarian at

3.
the border inspection post
concerned shall inform the authority in charge of the plant at
the place of destination of the consignment via the TRACES
system.

The outer packaging of

4.
be labelled:
LABORATORY REAGENTS ONLY’.

shall
‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/

intermediate products

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Official Journal of the European Union

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Article 5

Use and dispatch

The operator or owner of the plant of destination or his rep-
resentative shall use and/or dispatch the intermediate products
exclusively for the technical purposes specified in the approval
of the plant, as referred to in point (a) of Article 4(1).

Article 6

Records on use and dispatch

The competent authority shall carry out documentary
2.
checks at regular intervals for the purpose of reconciliation of
the quantities of intermediate products imported on the one
hand, and stocked, used, dispatched or disposed of on the
other, in order to check compliance with this Regulation.

3.
For consignments of intermediate products in transit, the
competent authorities responsible for the border inspection
posts of entry and of exit
respectively shall cooperate as
necessary to ensure that effective checks are carried out and
to ensure the traceability of such consignments.

The operator or owner of the plant of destination or his rep-
resentative shall keep records in accordance with Article 9(1) of
Regulation (EC) No 1774/2002 and shall provide the competent
authority on request with the necessary details of purchases,
sales, uses, stocks and disposals of surplus of the intermediate
products for the purposes of checking compliance with this
Regulation.

Article 8

Amendment to Annexes VIII and X of Regulation (EC)
No 1774/2002

Annexes VIII and X to Regulation (EC) No 1774/2002 are
amended in accordance with Annex III to this Regulation.

Article 7

Control

Article 9

Entry into force

that

The competent authority shall ensure, in accordance with
1.
Directive 97/78/EC,
intermediate
products are sent from the EU Member State in which the
inspection at the border inspection post shall be carried out
to the plant of destination, as referred to in Article 4(1) of
this Regulation, or in the case of transit, to the post of exit.

the consignments of

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 from 1 January 2007.

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

Done at Brussels, 22 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

28.12.2006

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Official Journal of the European Union

L 379/101

ANNEX I

Conditions for the registration or approval of the plant of origin in accordance with point (b) of Article 3

1. The operator or owner of the plant or his representative shall:

(a) ensure that

the plant has adequate facilities for the transformation of Category 3 material,

to ensure the

completion of the design, transformation and manufacturing stages referred to in Article 2;

(b) establish and implement methods of monitoring and checking the critical control points on the basis of the

process used;

(c) keep a record of the information obtained pursuant to (b) for a period of at least two years for submission to the

competent authority;

(d) inform the competent authority if any available information reveals the existence of a serious animal health or

public health hazard.

2. The competent authority of the third country shall at regular intervals carry out inspections of and supervise the plants

registered or approved in accordance with this Regulation.

(a) The frequency of inspections and supervision shall depend on the size of the plant, the type of products

manufactured, risk assessment and guarantees offered, based on the principles of the system of HACCP.

(b) If the inspection carried out by the competent authority reveals that the provisions of this Regulation are not being

complied with, the competent authority shall take appropriate action.

(c) The competent authority shall draw up a list of plants approved in accordance with this Regulation within its
territory. It shall assign an official number to each plant, which identifies the plant with respect to the nature of its
activities. The list and subsequent amendments shall be submitted to the EU Member State in which the inspection
at the border inspection post shall be carried out and to the Member State of destination.

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Official Journal of the European Union

28.12.2006

ANNEX II

Model declaration for the importation from third countries and for the transit
Community of intermediate products to be used for medical devices,

through the European
in vitro diagnostics and laboratory

reagents

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Official Journal of the European Union

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IN VITRO
MODEL DECLARATION FOR INTERMEDIATE PRODUCTS TO BE USED FOR MEDICAL DEVICES,
DIAGNOSTICS AND LABORATORY REAGENTS, FOR DISPATCH TO OR FOR TRANSIT THROUGH THE
EUROPEAN COMMUNITY

I, the undersigned, declare that the intermediate products referred to above are intended to be imported by me into the
Community and that:

1. they are derived from Category 3 material referred to in Article 6 of Regulation (EC) No 1774/2002 (1) and are

intended for the manufacture of medical devices, in vitro diagnostics or laboratory reagents;

2. their design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as
processed products and to qualify them for that purpose, except for the fact that they require some further handling or
transformation such as mixing, coating, assembling, packaging or labelling to make them suitable for placing on the
market or putting into service in accordance with the Community legislation applicable to the final products
concerned;

3. their outer packaging is labelled ‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/LABORATORY REAGENTS

ONLY’; and

4. they will not be diverted at any stage within the Community for any use in food, feed material, organic fertilisers or

soil improvers and will be conveyed directly to the following establishment:

Name:

................................................................................................. Address:

..........................................................................................

The importer

Name:

................................................................................................. Address:

..........................................................................................

Done at:

.............................................................................................................................................................................................................

(place)

(date)

Signature:

...........................................................................................................................................................................................................

(1) List of Category 3 materials (referred to in Regulation (EC) No 1774/2002 (OJ L 273, 10.10.2002, p. 1):

(a) parts of slaughtered animals, which are fit for human consumption in accordance with Community legislation, but are not intended

for human consumption for commercial reasons,

(b) parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected by any signs of diseases
communicable to humans or animals and derive from carcasses that are fit for human consumption in accordance with Community
legislation,

(c) hides and skins, hooves and horns, pig bristles and feathers originating from animals that were slaughtered in a slaughterhouse, after
for slaughter for human consumption in

undergoing ante-mortem inspection, and were fit, as a result of such inspection,
accordance with Community legislation,

(d) blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, after undergoing ante-mortem
inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Community
legislation,

(e) animal by-products derived from the production of products intended for human consumption, including degreased bones and

(f)

greaves,
former foodstuffs of animal origin, or former foodstuffs containing products of animal origin, other than catering waste, which are
no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or
other defects which do not present any risk to humans or animals,

(g) milk originating from animals which do not show any clinical signs of any disease communicable through that product to humans

or animals,

(h) fish or other sea animals, except sea mammals, caught in the open sea for the purposes of fishmeal production,
(i) by-products from fish from plants manufacturing fish products for human consumption,
(j) shells, hatchery by-products and cracked egg by-products originating from animals which did not show clinical signs of any disease

communicable through that product to humans or animals.

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ANNEX III

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

1. Annex VIII is amended as follows:

(a)

the heading of Chapter IV is replaced by the following:
‘Requirements for blood and blood products used for technical purposes, excluding the serum of equidae and
excluding intermediate products as referred to in Article 1 of Commission Regulation (EC) No 2007/2006’

(b) the heading of Chapter XI is replaced by the following:

‘Requirements for animal by-products for the manufacture of feed including petfood, and of technical products,
excluding intermediate products as referred to in Article 1 of Commission Regulation (EC) No 2007/2006’

2. Annex X is amended as follows:

(a)

‘For blood products to be used for technical purposes,
In Chapter 4(C), the heading of the Health certificate:
including pharmaceuticals, in vitro diagnostics and laboratory reagents, but excluding serum of equidae, intended
for dispatch to the European Community’, is replaced by the following heading:
‘For blood products, excluding serum of equidae and intermediate products as referred to in Article 1 of
intended for dispatch to the
Commission Regulation (EC) No 2007/2006, to be used for technical purposes,
European Community.’

(b) In Chapter 8, the heading of the Health certificates:

‘For animal by-products for the manufacture of technical
products (including pharmaceutical products) (1), intended for dispatch to the European Community’, is replaced by
the following heading:
‘For animal by-products (1) to be used for technical purposes, intended for dispatch to the European Community’

(1) Excluding raw blood, raw milk, hides and skins of ungulates and pig bristles (see relevant specific certificates for the import of these
products) as well as wool, hair, feathers or parts of feathers. This certificate is not to be used for intermediate products as defined by
Regulation (EC) No 2007/2006 (see relevant conditions and model declaration for import of these products).