Public Health

• Author: International Law Group
• Pages: 13-16

Page 13

In 1990, the Council of the European Communities established a Community procedure for defining maximum residue limits (MRLs) of veterinary medicinal products in foodstuffs of animal origin. The preamble to Regulation (EEC) No. 2377/90 [R-2377/90] sets forth the protection of public health as one of its goals and stresses the importance of using a single scientific judgment of the highest quality to make decisions about MRLs.

The Regulation clas s ifies pharmacologically active substances that are administered to food-producing animals into four annexes: Annex I includes substances with fixed MRLs; Annex II comprises substances not subject to MRLs; Annex III consists of substances subject to provisional MRLs; and Annex IV includes substances for which no MRL can be established.

Articles 4 and 14 of R-2377/90, as amended by Council Regulation (EC) No. 434/97, are central to the current appeal. Article 4 bars the setting of provisional MRLs unless there is no evidence that the residues of the substance in question at the level proposed present a hazard to the health of EU consumers. Article 14 originally set January 1, 1997 as the effective date of the ban on the giving of substances to food producing animals not listed in Annexes I, II, or II..

Regulation (EC) 464/97 moved the effective date up to January 1, 2000. In April 1996, Council Directive 96/22/EC barred the administration to farm animals of substances such as progesterone that have a gestagenic [aiding in the development and retention of pregnancy] action. Member States, however, may allow the use of such substances for therapeutic purposes.

Pfizer Enterprises Sarl and CEVA Sante Animale SA (plaintiffs) asked the EC Commission in 1993 to come up with an MRL for giving progesterone to cattle and horses. The European Agency for the Evaluation of Medicinal Products (the EMEA) notified plaintiffs in November 1996 that the Committee on Veterinary Medicinal Products (the CVMP) had recommended the inclusion of progesterone in Annex II to R-2377/90.

Page 14

The EMEA told plaintiffs that it would send the CVMP's recommendation to the EC Commission for adoption.

In April 1997, however, the EMEA asked the CVMP to reconsider its assessment of progesterone risks in light of new scientific information. Almost two years later, the United Nations's Joint FAO/WHO Expert Committee on Food Additives (JEFCA) reported that a numerical MRL would not be necessary for progesterone.

The Commission next sent EMEA the April 1999 opinion of the Scientific Committee on Veterinary Measures Relating to Public Health (the SCVPH). It had concluded that scientific uncertainties as to the effects of certain hormones, including progesterone, ruled out the setting of a threshold level or an...