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See also Commission Press Release: 24 May 2000 HORMONES - Commission proposes revised legislation banning hormones as growth promoters
WTO Dispute Settlement and Appellate Body Findings
In 1996, the US and Canada held formal consultations in the framework of the WTO dispute settlement mechanism with the EU regarding its legislation covering the ban on hormones (17 beta-oestradiol, progesterone, testosterone, zeranol, trenbolone and melengestrol acetate) for growth promoting purposes in livestock. Following requests from the two countries, WTO panels were set up to assess the conformity of the EC measures with its WTO obligations. The reports from these panels were delivered in August 1997. The EC measures were found not to be in conformity with a number of WTO rules. The EU objected to the conclusions of the panels in September 1997, which were consequently submitted for review to the Appellate Body.
On 13 February 1998 the report of the Appellate Body was adopted which in particular found that the Community had provided "general studies which do indeed show the existence of a general risk of cancer; but they do not focus on and do not address the particular kind of risk at stake here - the carcinogenic or genotoxic potential of the residues of those hormones found in meat derived from cattle to which the hormones had been administered for growth promotion purposes … those general studies are in other words relevant but do not appear to be sufficiently specific to the case at hand."
The Appellate Body clarified, however, that a WTO Member;
The report mentioned Article 5.7, which deals with measures taken when scientific information is insufficient. This article permits members to take measures, but they must be provisional and based on pertinent information. Members are obliged to seek the additional information necessary for a more objective assessment of risk and to review the measures within a reasonable period of time.
The Appellate Body recommended that the EC bring its measures into conformity with its obligations under the SPS Agreement.
On 29 May 1998 the Arbitrator granted the Community a "reasonable period" of 15 months from the adoption of the recommendations to implement those recommendations that is, until 13 May 1999.
Scientific Response to the Appellate Body Ruling
Following the indications of the WTO Appellate Body, the Commission launched in early 98 a series of 17 studies concerning the issues the Appellate Body indicated as relevant to improve and complement current knowledge. They concern toxicological aspects, residue analysis, abuse and control aspects and environmental aspects.
In response to the WTO Appellate Body's main concern about the need for a comprehensive risk assessment the Commission mandated the Scientific Committee of Veterinary measures relating to Public Health (SCVPH) at the end of 1998 to deliver an assessment of the risk to human health arising from the use of the six hormones as growth promoters, in particular from residues in meat and meat products.
The SCVPH adopted its opinion in April 99, concluding that for all six hormones endocrine, developmental, immunological, neurobiological, immunotoxic and carcinogenic effects could be envisaged. For 17ß Oestradiol the SCVPH concludes that there is a substantial body of evidence suggesting that it has to be considered a complete carcinogen, but it was not possible to quantify the risk. For the other five hormones the available information is incomplete and does not allow a quantitative estimate of the risk, however a risk to consumers was identified. Of particular relevance to the SCVPH is that even exposure to small traces in meat carries risks. No threshold levels can be defined for any of the six substances. Of the various susceptible risk groups prepubertal children is the group of greatest concern.
The opinion of the SCVPH was elaborated in full awareness of the 17 ongoing studies and with direct scientific feedback from the experts involved. However, the SCVPH was not involved in the setting up and management of the studies. The Commission intends to allow completion of the few still ongoing from the 17 scientific studies, and will keep the SCVPH fully informed of progress and results. It is important to note that in the meantime the SCVPH has concluded that very significant gaps in current knowledge exist.
The results of the 17 studies have been or are being made available to the scientific community as they come forward. These results are expected to be made publicly available by the scientists concerned through presentations and publication in scientific journals following the normal peer review process, which may take several months.
Legal response to the Appellate Body Ruling
The US, on 17 May 1999, had requested the Dispute Settlement Body of the WTO to authorise the suspension of the application to the EC and its Member States of tariff concessions covering trade in an amount of US$ 202 million per year. A similar request was made by Canada on 20 May 1999 for an amount of CDN$ 75 million per year. The EC objected to the level of suspension proposed by the US and Canada, and, on 12 July 1999, the WTO Arbitrator determined that the level of nullification or impairment suffered by the US and Canada was US$ 116.8 million per year, and CND$ 11.3 million per year, respectively.
The US suspended the application of tariff concessions by imposing a 100% ad valorem rate of duty on mainly agricultural products from 29 July 1999. On 1 August 1999, Canada also imposed 100% ad valorem tariffs on, in particular, beef and pork products.
Latest Scientific Review and Commission response
Since adoption of the SCVPH opinion on 30 April 1999, some new reports have been published on this subject. In the light of this information, the Commission asked the SCVPH to either confirm that there is no recent scientific information that would lead it to revise its previous opinion, or to revise the relevant parts of the opinion as necessary. On 3rd May 2000, the SCVPH delivered an opinion that recent scientific reports did not provide convincing data and arguments requiring a revision of the conclusion drawn in their opinion of 30 April 1999.
In the light of that opinion, the Commission concluded that it would not be appropriate to lift the existing ban on the use of growth promoting hormones for meat production.
Furthermore, the Commission considers that the strength of the evidence as presented in the opinion of 30 April 1999 against 17ß oestradiol is strong enough to justify a permanent ban on its use for any purposes for farm animals. For the other hormones, the SCVPH has outlined areas where more information is required. For this reason, the Commission considers that a provisional ban will be in compliance with the ruling of the Appellate Body, while recognising the need to seek further information and to review the measures in the light of future evidence.