![]() |
[Home] [Databases] [World Law] [Multidatabase Search] [Help] [Feedback] [DONATE] | |||||||||
Court of Justice of the European Communities (including Court of First Instance Decisions) |
||||||||||
PLEASE SUPPORT BAILII & FREE ACCESS TO LAW
To maintain its current level of service, BAILII urgently needs the support of its users.
Since you use the site, please consider making a donation to celebrate BAILII's 25 years of providing free access to law. No contribution is too small. If every visitor this month gives just Β£5, it will have a significant impact on BAILII's ability to continue providing this vital service.
Thank you for your support! | ||||||||||
You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> cp-Pharma (Agriculture) [2008] EUECJ C-448/06 (17 July 2008) URL: https://www.bailii.org/eu/cases/EUECJ/2008/C44806.html Cite as: [2008] EUECJ C-448/6, [2008] EUECJ C-448/06 |
[New search] [Printable version] [Help]
(Reference for a preliminary ruling - Validity of Regulation (EC) No 1873/2003 - Veterinary medicinal products - Regulation (EEC) No 2377/90 - Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin - Progesterone - Restrictions on use - Directive 96/22/EC)
In Case C-448/06,
REFERENCE for a preliminary ruling under Article 234 EC from the Verwaltungsgericht Köln (Germany), made by decision of 24 October 2006, received at the Court on 2 November 2006, in the proceedings
cp-Pharma Handels GmbH
Bundesrepublik Deutschland,
composed of P. Jann, President of the Chamber, A. Tizzano (Rapporteur), A. Borg Barthet, M. IleΕ‘ic and E. Levits, Judges,
Advocate General: J. MazΓ‘k,
Registrar: J. Swedenborg, Administrator,
having regard to the written procedure and further to the hearing on 18 October 2007,
after considering the observations submitted on behalf of:
- cp-Pharma Handels GmbH, by R. Köhne, Rechtsanwalt,
- the Greek Government, by S. Charitaki and S. Papaioannou, acting as Agents,
- the Polish Government, by E. Osniecka-Tamecka, acting as Agent,
- the Commission of the European Communities, by B. Stromsky and B. Schima, acting as Agents,
after hearing the Opinion of the Advocate General at the sitting on 16 January 2008,
gives the following
Legal context
Community legislation
The provisions concerning the establishment of maximum residue limits
- Regulation (EEC) No 2377/90
'-¦ the use of veterinary medicinal products in food-producing animals may result in the presence of residues of foodstuffs obtained from treated animals;
-¦
-¦ in order to protect public health, maximum residue limits ['MRLs'] must be established in accordance with generally recognised principles of safety assessment, taking into account any other scientific assessment of the safety of the substances concerned which may have been undertaken by international organisations, in particular the Codex Alimentarius or, where such substances are used for other purposes, by other scientific committees established within the Community'.
-1. The Committee for Veterinary Medicinal Products referred to in Article 27 of Regulation (EEC) No 2309/93 (hereinafter the [CVMP]-) shall be responsible for formulating the Agency's opinion on the classification of substances referred to in Annex I, II, III or IV to this Regulation.
-¦
5. The Agency shall forward the definitive opinion of the [CVMP] within 30 days of its adoption both to the Commission and to the applicant. The opinion shall be accompanied by a report describing the safety evaluation of the substance by the Committee, which shall give the grounds for its conclusions.
6. The Commission shall prepare draft measures taking account of Community legislation -¦'
'With effect from 1 January 1997, the administration to food-producing animals of veterinary medicinal products containing pharmacologically active substances which are not mentioned in Annex I, II or III shall be prohibited within the Community -¦'
- Regulation No 1873/2003
'Only for intravaginal therapeutic or zootechnical use and in accordance with [Council] Directive 96/22/EC [of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of Γ-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ 1996 L 125, p. 3)]'.
'(6) The SCVPH [Scientific Committee on Veterinary Measures relating to Public Health] repeatedly confirmed that the use of hormones for growth promotion purposes in meat production poses a potential health risk to consumers due to their intrinsic pharmacological and toxicological properties and epidemiological findings. However, at present the data available on progesterone are insufficient to make any quantitative estimate of the risk arising from the exposure to residues in meat and meat products originating from treated animals. No threshold levels can be defined for progesterone in this regard.
-¦
(8) Animals also naturally produce progesterone. The level of endogenous secretion of progesterone in the animals is variable, depending notably on gender, age, breed and sexual cycle. Validated methods are available to detect progesterone in animal tissues. However, these methods cannot distinguish between naturally occurring hormones and residues of progesterone as a means of controlling that the restrictions of use established in Directive 96/22/EC are observed.
-¦
(10) The Commission considers that safeguards as to the possibility of misuse of veterinary medicinal products containing progesterone are necessary. Restricting the terms of the use of progesterone to administration only via the intravaginal route in female animals of bovine, ovine, caprine and equine species provides this additional safeguard needed to avoid misuse as the relevant veterinary medicinal products cannot, due to their specific presentation, be realistically used for prohibited purposes. It is therefore considered appropriate to include progesterone in Annex II to Regulation -¦ No 2377/90 in accordance with the Annex to the present proposal for a Commission Regulation, which limits the use of progesterone to this specific purpose and product formulation.'
The other relevant provisions
- Directive 96/22
- Directive 2001/82/EC
'In order that a veterinary medicinal product may be the subject of a marketing authorisation for the purpose of administering it to food-producing animals, the active substances which it contains must be shown in Annex I, II or III of Regulation -¦ No 2377/90.'
'[Directives] 81/851/EEC, 81/852/EEC, 90/677/EEC and 92/74/EEC -¦ are repealed -¦'
The reference made to the said Repealed Directives shall be construed as references to this Directive -¦'
National legislation
'An authorisation -¦ must be revoked where one of the grounds for refusal under Paragraph 25(2)(3),(5),(5a), (6) or (7) subsequently arises.'
'The competent higher federal authority may refuse to grant an authorisation only if
-¦
7. the marketing of the medical product or its administration to animals would contravene legal provisions or a regulation, directive or decision of the Council or Commission -¦'
The dispute in the main proceedings and the question referred for a preliminary ruling
'Is -¦ Regulation -¦ No 1873/2003 -¦ partially void on account of a breach of higher-ranking Community law (Articles 1(1) and 3 of -¦ Regulation -¦ No 2377/90 in conjunction with Article 4(1) of -¦ Directive 96/22 -¦), in so far as application of an injection solution as a pharmaceutical form is excluded by virtue of the note marked (*) against the listing of progesterone in Annex II to -¦ Regulation -¦ No 2377/90?'
The question referred
Costs
On those grounds, the Court (First Chamber) hereby rules:
Examination of the question referred has disclosed no factor of such a kind as to affect the validity of Commission Regulation (EC) No 1873/2003 of 24 October 2003 amending Annex II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.
[Signatures]
* Language of the case: German.