CELEX: 62008CJ0562
System for monitoring bovine spongiform encephalopathy
Regulation (EC) No 999/2001
Bovine animals over 30 months of age
Slaughter under normal conditions
Meat intended for human consumption
Mandatory screening test
National rules
Obligation to screen
Extension
Bovine animals over 24 months of age

This reference for a preliminary ruling concerns the interpretation of Article 6(1) 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 encephalopathies (OJ 2001 L 147, p. 1) and of Annex III, Chapter A, Part I to that regulation, as
amended by Commission Regulation (EC) No 1248/2001 of 22 June 2001 (OJ 2001 L 173, p. 12).
The reference was made in the course of proceedings between Müller Fleisch GmbH (‘Müller Fleisch’) and the Land Baden-Württemberg
regarding the fee charged for screening tests for bovine spongiform encephalopathy (‘BSE’) carried out in its undertaking
in July 2001 on bovine animals intended for slaughter.

Legal context

Community legislation
Regulation No 999/2001 was adopted on the basis of Article 152(4)(b) EC. As is apparent from recital 2 to that regulation,
the regulation concerns the adoption of specific rules for the prevention, control and eradication of certain transmissible
spongiform encephalopathies (‘TSEs’), including BSE, in view of the magnitude of the risk they pose to human and animal health.
The first subparagraph of Article 6(1) of Regulation No 999/2001, entitled ‘Monitoring system’, provides:
‘Each Member State shall carry out an annual programme for monitoring BSE and scrapie in accordance with Annex III, Chapter
A. That programme shall include a screening procedure using rapid tests.’
In the original version of Regulation No 999/2001, Annex III, Chapter A, Part I set out the ‘Minimum requirements for a programme
for monitoring BSE in bovine animals’. It provided, inter alia, for the selection of certain sub-populations of bovine animals
over 30 months of age, including those slaughtered normally for human consumption, for the purposes of that programme.
Annex III, Chapter A, Part III to the original version of Regulation No 999/2001 was entitled ‘Monitoring in higher risk animals’
and provided:
‘In addition to the monitoring programmes set out in Parts I and II, Member States may on a voluntary basis carry out targeted
surveillance for TSE in higher risk animals, such as:
–        animals originating from countries with indigenous TSE,
–        animals which have consumed potentially contaminated feedingstuffs,
–        animals born or derived from TSE-infected dams.’
Recitals 2 and 7 to Regulation No 1248/2001 state:
‘(2) In view of the detection of [BSE] in two bovine animals at the age of 28 months in routine testing of casualty slaughtered
animals and to provide an early warning system of the emergence of any unfavourable trends in BSE incidence in younger animals,
the age limit should be reduced to 24 months in animals belonging to certain risk populations.
…
(7) Member States should be allowed to test other bovine animals on a voluntary basis, in particular where those animals are
considered to present a higher risk, provided it is done without disrupting trade.’
Regulation No 1248/2001 amends, inter alia, Annex III to Regulation No 999/2001. Annex III, Chapter A, Part I, as amended
(referred to in paragraphs 9 to 11 below as ‘Part I’), applied as from 1 July 2001 and is headed ‘Monitoring in bovine animals’.
Point 2 of Part I, which concerns monitoring in animals slaughtered for human consumption, states:
‘2.1. All bovine animals over 24 months of age:
–         subject to “special emergency slaughtering” as defined in Article 2(n) of Council Directive 64/433/EEC [of 26 June 1964 on
health problems affecting intra-Community trade in fresh meat (OJ, English Special Edition 1963-1964, p. 185)], or
–        slaughtered in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC,
shall be tested for BSE.
2.2. All bovine animals over 30 months of age subject to normal slaughter for human consumption shall be tested for BSE.
…’
Point 3 of Part I provides that bovine animals over 24 months of age which have died or been killed for purposes other than,
inter alia, human consumption are to be tested for BSE at random in accordance with the minimum sample sizes specified in
that point.
Point 5 of Part I, headed ‘Monitoring in other animals’, provides:
‘In addition to the testing referred to in points 2 to 4, Member States may on a voluntary basis decide to test other bovine
animals on their territory, in particular where those animals originate from countries with indigenous BSE, have consumed
potentially contaminated feedingstuffs or were born or derived from BSE infected dams.’

National legislation
The Regulation on the screening of slaughtered bovine animals for BSE in accordance with meat hygiene law (Verordnung zur
fleischhygienerechtlichen Untersuchung von geschlachteten Rindern auf BSE) of 1 December 2000 (BGBl. 2000 I, p. 1659), as
amended by the Regulation of 25 January 2001 (BGBl. 2000 I, p. 164), (‘the BSE-Untersuchungsverordnung’) makes screening for
BSE mandatory.
It is apparent from the order for reference that, after a case of BSE was identified in Germany in a 28-month-old bovine animal,
the general age limit for screening bovine animals for BSE was reduced from 30 to 24 months by virtue of the regulation of
25 January 2001.
Paragraph 1(1) of the BSE-Untersuchungsverordnung thus provides that bovine animals over 24 months of age are to be tested
using one of the approved tests listed in Annex IVA to Commission Decision 98/272/EC of 23 April 1998 on epidemio-surveillance
for transmissible spongiform encephalopathies and amending Decision 94/474/EC (OJ 1998 L 122, p. 59).

The dispute in the main proceedings and the question referred for a preliminary ruling
Müller Fleisch is a slaughtering and cutting business in the meat processing industry. By assessment notice dated 18 October
2001, the Landratsamt Enzkreis (Chief Administrative Office for the District of Enz) required Müller Fleisch to pay fees for
BSE screening tests carried out at its premises in July 2001 on bovine animals for slaughter. That payment included, inter
alia, a sum of EUR 31 401.56 for tests carried out on bovine animals of 24 to 30 months of age.
The applicant in the main proceedings brought an action challenging the legality of those fees, maintaining, inter alia, that
Article 6(1) of Regulation (EC) No 999/2001 in conjunction with Annex III, Chapter A, Part I thereto does not permit general
BSE screening to be introduced for bovine animals in that age bracket.
Müller Fleisch was not successful either in that action or on appeal. The appeal court held that the general obligation laid
down by Community law to screen bovine animals over 30 months of age does not entail a prohibition on the screening of younger
bovine animals, as Annex III, Chapter A, Part I, point 5 to Regulation (EC) No 999/2001 expressly permits Member States to
screen other bovine animals, in so far as it is done without disrupting trade. There had been no such disruption in the present
case.
The Bundesverwaltungsgericht (Federal Administrative Court), before which an appeal on a point of law has been brought, is,
by contrast, of the opinion that the fact that Annex III, Chapter A, Part I to Regulation (EC) No 999/2001 establishes a specific
monitoring system, with detailed rules, militates against such an extension of screening requirements. According to that court,
it is apparent from the second and third examples in Annex III, Chapter A, Part I, point 5 to Regulation (EC) No 999/2001
that, by means of that point, the Community legislature envisaged only selective additions to the screening programme provided
for. Furthermore, bovine animals of 24 to 30 months of age cannot be considered to be ‘other animals’ within the meaning of
that provision since the screening requirements which relate to them are already regulated in a specific manner. Lastly, substantial
changes to the Community programme might result in a disruption in trade.
In those circumstances, the Bundesverwaltungsgericht decided to stay the proceedings and refer the following question to the
Court for a preliminary ruling:
‘Is Article 6(1) of Regulation … No 999/2001…, in conjunction with Annex III, Chapter A, Part I to that regulation, as amended
by … Regulation [No 1248/2001] … to be interpreted as precluding the extension of mandatory screening to all bovine animals
over 24 months of age, as established by the BSE-Untersuchungsverordnung…?’

The question referred for a preliminary ruling
By its question, the national court asks, in essence, whether Article 6(1) of Regulation No 999/2001 and Annex III, Chapter
A, Part I to that regulation, as amended by Regulation No 1248/2001, preclude national rules under which all bovine animals
over 24 months of age must be screened for BSE.
It is apparent from the first subparagraph of Article 6(1) of Regulation No 999/2001 that the annual programme for monitoring
BSE that Member States are required to carry out, which must include a screening procedure, must be in accordance with Annex
III, Chapter A to that regulation.
Annex III, Chapter A, Part I, points 2 and 3, as amended by Regulation No 1248/2001, provide that, first, all bovine animals
over 30 months of age which are subject to normal slaughter for human consumption and, secondly, bovine animals over 24 months
of age which belong to certain populations identified in those points must be tested for BSE.
Furthermore, under point 5 of Part I, Member States may test bovine animals other than those mentioned, inter alia, in points
2 and 3 of Part I, which are on their territory.
According to Müller Fleisch, that possibility does not go so far as to enable Member States to impose a screening procedure
for all bovine animals over 24 months of age, as provided for by the German rules at issue in the main proceedings, but permits
only the targeted screening of higher risk animals.
In that regard, first, even if the animals mentioned in the second and third examples in the list in Annex III, Chapter A,
Part I, point 5 to Regulation No 999/2001, as amended by Regulation No 1248/2001, were to be regarded as belonging to specific
and restricted higher risk groups, the first example, namely animals which originate from countries with indigenous BSE, potentially
covers the whole bovine animal population of such a country. Secondly, the words ‘in particular’ which precede the list of
circumstances in which screening tests may be carried out on other bovine animals show that that list is not exhaustive.
Likewise, by using the words ‘in particular’ in recital 7 to Regulation No 1248/2001, the Community legislature showed that
it did not intend to restrict Member States’ power to impose such tests solely to animals regarded as presenting a higher
risk.
That finding is also borne out by the fact that the provision corresponding to the abovementioned point 5 in the original
version of Annex III to Regulation No 999/2001, namely Chapter A, Part III of that annex, stated that Member States could
carry out targeted surveillance in higher risk animals, whereas there is no such restriction in point 5.
It must be held that the wording of Annex III, Chapter A, Part I, point 5 to Regulation No 999/2001, as amended by Regulation
No 1248/2001, in no way bears out the interpretation of that provision proposed by Müller Fleisch and does not preclude the
imposition, by a Member State, of screening tests on all bovine animals over 24 months of age on its territory.
However, the applicant in the main proceedings submits that, as mandatory screening in respect of bovine animals of 24 to
30 months of age has already been provided for in Part I, points 2 and 3, the animals in that age bracket cannot be considered
to be ‘other bovine animals’ within the meaning of that provision and that the Community legislature did not leave the introduction
of tests on other animals to the discretion of Member States.
That argument cannot be upheld.
First, that argument is tantamount to maintaining that Annex III, Chapter A, Part I, points 2 and 3 to Regulation No 999/2001,
as amended by Regulation No 1248/2001, regulate the screening of bovine animals of 24 to 30 months of age exhaustively, with
the result that point 5 of Part I would apply only to bovine animals in other age brackets. It would then have to be accepted
that the same is true as regards animals over 30 months of age since points 2 and 3 also relate to tests on them. It would
follow that point 5 would apply only to bovine animals under 24 months of age, which would to a great extent render it redundant.
Secondly, it must be pointed out that Regulation No 999/2001 has, in accordance with its legal basis, namely Article 152(4)(b)
EC, as its direct objective the protection of public health. According to settled case-law, the health and life of humans
rank foremost among the assets and interests protected by the EC Treaty and it is for the Member States to determine the level
of protection which they wish to afford to public health and the way in which that level is to be achieved, which implies
that Member States must be allowed discretion (see, to that effect, Case C-141/07
Commission
v
Germany
[2008] ECR I-6935, paragraph 51; Case C-169/07
Hartlauer
[2009] ECR I-0000, paragraph 30; and Joined Cases C-171/07 and C-172/07
Apothekerkammer des Saarlandes and Others
[2009] ECR I-0000, paragraph 19).
Such a discretion is in accordance with the objective set out in recital 2 to Regulation No 1248/2001 of providing an early
warning system of the emergence of any unfavourable trends in BSE incidence in younger animals. Such a discretion is also
made apparent in recital 7 to that regulation, which shows, by its use of the word ‘considered’, that whether it is appropriate
to test other bovine animals is a matter for the Member States to assess.
The amendments made by Regulation No 1248/2001 to Annex III to Regulation No 999/2001 show an increased discretion as against
the original version of that annex. As was pointed out in paragraph 27 of this judgment, Member States are no longer restricted
to targeted screening of higher risk animals.
It follows that Regulation No 999/2001 grants Member States a discretion as regards the bovine animals which they may screen
for BSE.
It follows from the foregoing that the provisions of Regulation No 999/2001 at issue in the main proceedings do not, in principle,
preclude the extension by a Member State of mandatory BSE screening to all bovine animals over 24 months of age on its territory.
However, recital 7 to Regulation No 1248/2001 states that Member States should be allowed to test other bovine animals in
so far as it is done without disrupting trade.
It must be observed at the outset that that clarification is not to be understood as referring to all disruptions in trade.
First, any screening procedure is liable to result in some such disruptions, such as delays for example, however minor they
may be.
Secondly, although it is true that allowing Member States to test other bovine animals on a voluntary basis may result, in
a Member State which imposes stricter standards in that regard, in the discovery of a sufficiently high number of cases of
BSE for that Member State to be downgraded in the categories defined in Annex II to Regulation No 999/2001, headed ‘Determination
of BSE status’, the fact remains that the disruptions in exports of animals and products of animal origin which might arise
ought to contribute to the objective of protecting human and animal health.
It is also important to point out that the issue of disruptions in trade is not explicitly mentioned in the enacting terms
of Regulations Nos 999/2001 and 1248/2001. As the preamble to a Community act has no binding legal force (Case C-134/08
Tyson Parketthandel
[2009] ECR I‑0000, paragraph 16 and the case-law cited), the clarification in recital 7 to Regulation No 1248/2001 must,
as the Commission of the European Communities maintained at the hearing, be interpreted as a reference to primary law and,
in particular, to the principle of proportionality.
The Member States must, in exercising the discretion described in paragraphs 32 to 35 of this judgment, comply with the provisions
of the Treaty on the free movement of goods where applicable. Those provisions prohibit the Member States from introducing
or maintaining, as regards the objective of the protection of public health, unjustified restrictions on the exercise of that
freedom (see, by analogy, Case C‑372/04
Watts
[2006] ECR I-4325, paragraph 92;
Commission
v
Germany
, paragraph 23; and
Apothekerkammer des Saarlandes and Others
, paragraph 18).
With regard to the screening tests that a Member State decides to carry out on a part of the bovine population in pursuit
of that objective, it cannot be accepted that there is a disproportionate disruption in trade.
In accordance with the principle of proportionality, which is one of the general principles of European Union law, the lawfulness
of such screening tests is subject to the condition that they are appropriate and necessary in order to attain the objectives
legitimately pursued; when there is a choice between several appropriate measures, recourse must be had to the least onerous,
and the disadvantages caused must not be disproportionate to the aims pursued (see, by analogy, Case C‑220/01
Lennox
[2003] ECR I-7091, paragraph 76).
In that regard, the introduction of testing for all bovine animals of 24 to 30 months of age is an appropriate measure for
detecting cases of BSE in animals in that age bracket and therefore for achieving the desired objective.
Furthermore, as regards the necessity of that measure, it must be borne in mind that Member States have a discretion in that
field. Therefore, the fact that one Member State imposes less strict rules than another Member State does not mean that the
latter’s rules are disproportionate (
Commission
v
Germany
, paragraph 51)
Likewise, the fact that, in response to the discovery of isolated cases of BSE in animals of 28 months of age, as is apparent
from recital 2 to Regulation No 1248/2001 and the order for reference, the Community legislature required, in respect of bovine
animals over 24 months of age, less extensive testing than that introduced by a Member State does not mean that that State
may not properly regard that testing as necessary.
Lastly, a national measure, such as that at issue in the main proceedings, does not appear to go beyond what is necessary
to achieve the objective of the protection of public health as it results from Regulation No 999/2001.
Therefore, the answer to the question referred is that Article 6(1) of Regulation No 999/2001 and Annex III, Chapter A, Part
I to that regulation, as amended by Regulation No 1248/2001, do not preclude national rules under which all bovine animals
over 24 months of age must be screened for BSE.

Costs
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court,
the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs
of those parties, are not recoverable.
On those grounds, the Court (Second Chamber) hereby rules:
Article 6(1) 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 encephalopathies and Annex III, Chapter A,
Part I to that regulation, as amended by Commission Regulation (EC) No 1248/2001 of 22 June 2001, do not preclude national
rules under which all bovine animals over 24 months of age must be screened for bovine spongiform encephalopathy.
[Signatures]
*
Language of the case: German.