Minichan

In 1981, with Directive 81/602/EEC, the EU prohibited the use of substances having a hormonal action for growth promotion in farm animals. Examples for these kind of growth promoters are oestradiol 17ß, testosterone, progesterone, zeranol, trenbolone acetate and melengestrol acetate (MGA).

This prohibition applies to Member States and imports from third countries alike. The legal instrument in force is Directive 96/22/EC as amended by Directive 2003/74/EC.

The former Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) thoroughly re-evaluated the risks to human health from hormone residues in bovine meat and meat products treated with six hormones for growth promotion. In 1999 this independent scientific advisory body concluded that no acceptable daily intake (ADI) could be established for any of these hormones. For oestradiol 17ß it concluded that there is a substantial body of evidence suggesting that oestradiol 17ß has to be considered as a complete carcinogen (exerts both tumour initiating and tumour promoting effects) and that the data available would not allow a quantitative estimate of the risk. Having examined additional scientific data the SCVPH confirmed its opinion in 2000 and 2002.

Based on this scientific opinion, the Commission proposed to the European Parliament and to the Council to amend Directive 96/22/EC concerning the prohibition of the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists in May 2000.

The European Parliament and the Council on 22 September 2003 amended Directive 96/22/EC through the adoption of Directive 2003/74/EC following a co-decision procedure according to Article 252 of the Treaty.

As amended, the Directive confirms the prohibition of substances having a hormonal action for growth promotion in farm animals. Moreover, it drastically reduces the circumstances under which oestradiol 17ß may be administered for other purposes to food producing animals. Only three uses remain permissible on a transitional basis and under strict veterinary control:

Treatment of foetus maceration/mummification
Pyometra in cattle (for animal welfare reasons), and
Oestrus induction in cattle, horses, sheep and goats (the latter use was phased out in autumn 2006)
In October 2005 the Commission presented a report on the availability of alternative veterinary medicinal products to those containing oestradiol 17ß or its ester-like derivatives for the treatment of foetus maceration/mummification in cattle and for the treatment of pyometra in cattle.

The Commission keeps taking into account any new emerging scientific data from any source.

International Aspects
The United States and Canada contested the prohibition of the use of hormones as growth promoters in food producing animals, and in 1997 a panel of the World Trade Organisation (WTO) ruled that the EU measure was not in line with the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS).

The EU appealed against this ruling and, in 1998, the WTO Appellate Body reversed most of the findings of the panel. The WTO Appellate Body only upheld the finding that prohibition of imports of meat from hormone-treated animals to the EU did not comply with the requirement that such a measure should be based on a relevant assessment of the risks to human health.

In reaction to these findings, the EU mandated a new assessment of the risks to human health from hormone residues in bovine meat and meat products treated with six hormones used for growth promotion. Subsequently the EU amended Directive 96/22/EC by adoption of Directive 2003/74/EC and thus implemented its international obligations in the context of the World Trade Organisation.

Since the 1950s, the Food and Drug Administration (FDA) has approved a number of steroid hormone drugs for use in beef cattle and sheep, including natural estrogen, progesterone, testosterone, and their synthetic versions. These drugs increase the animals’ growth rate and the efficiency by which they convert the feed they eat into meat.

The FDA approves these drugs only after information and/or studies have shown that the food from the treated animals is safe for people to eat, and that the drugs do not harm the treated animal or the environment. The drugs also have to be effective, meaning that they work as intended. The labeling for each product provides all instructions for safe and effective use and is approved by FDA. For each approved product, the FDA also makes available to the public via its website a Freedom of Information Summary that summarizes the information that FDA used to determine that the drug is safe for the treated animals, the animal products (edible tissues such as meat) are safe for humans to eat, and that the product is effective.

These steroid hormone drugs are typically formulated as pellets or “implants” that are placed under the skin on the back side of the animal’s ear. The implants dissolve slowly under the skin and do not require removal. The ears of the treated animals are discarded at slaughter and are not used for human food. Using scientific data, FDA establishes the acceptable safe limits for hormones in meat. A safe level for human consumption is a level of drug in the meat that would be expected to have no harmful effect in humans based on extensive scientific study and review.

All approved steroid implant products have a zero day withdrawal. This means that the meat from the animal is safe for humans to eat at any time after the animal is treated.

No steroid hormone implants are approved for growth purposes in dairy cows, veal calves, pigs, or poultry. All of the steroid hormone implants are available for over-the-counter purchase in the U.S. and are generally given by the livestock producer at specific stages of the animals’ growth. Unless otherwise approved and labeled for reimplantation, only one ear implant may be given to an animal during a specific stage of growth.

Naturally-Occurring Hormones
Some of the approved drugs are naturally produced throughout life in people and animals, such as estradiol (estrogen), progesterone, and testosterone. These natural hormones are necessary for normal development, growth, and reproduction. People are not at risk from eating food from animals treated with these drugs because the amount of additional hormone following drug treatment is very small compared with the amount of natural hormones that are normally found in the meat of untreated animals and that are naturally produced in the human body.

Synthetic Hormones
Some of the approved drugs are synthetic versions of the natural hormones, such as trenbolone acetate and zeranol. Just like the natural hormone implants, before FDA approved these drugs, FDA required information and/or toxicological testing in laboratory animals to determine safe levels in the animal products that we eat (edible tissues). Furthermore, FDA required that the manufacturers demonstrate that the amount of hormone left in each edible tissue after treatment is below the appropriate safe level. As described above, a safe level is a level which would be expected to have no harmful effect in humans.