The representative of the United States reiterated concerns that Israel had so far not published a draft infant formula regulation and notified it for comment to the WTO. He recalled that importers needed clarity regarding the Israeli Ministry of Health requirements for infant formula so that trade was not disrupted. He requested that Israel provide an update on the status and timing of the draft regulation as well as on the ongoing domestic litigation regarding the infant formula regulation.

The representative of Israel explained that the issue was currently being discussed in Israel. He said that Israel would inform the US representative about any new developments in a timely manner. He also informed the US delegate that a meeting among interested importers, exporters and high-level health authorities in Israel would be held with the view to further discussing the matter and exploring ways to reach a satisfactory solution.

The representative of the United States noted his delegation's continued concerns that Israel had not published a draft regulation on its measures related to infant formula for comments, nor notified it to the WTO. He noted that the detailed comments of the United States could be found in the minutes of previous TBT Committee meetings and sought an update on the current status of the draft regulation. The US representative also noted that the United States had had a fruitful bilateral meeting with the Israeli Ministry of Health. It was his delegation's hope that continued bilateral discussions would help to resolve this issue before the end of 2009.

The representative of Israel thanked the US delegation for the comments provided and explained that this highly sensitive issue was currently being addressed bilaterally. The delegation of Israel would update the Committee about the progress.

The representative of the United States noted that his delegation's continued concerns that Israel had not published a draft regulation on its measures related to infant formula for comments, nor notified it to the WTO. Industry in the United States continued to have concerns that Israel's unpublished requirements for infant formula discriminated against imports and were unduly costly, burdensome and unpredictable. He stressed that while Israel denied these allegations, it had failed to publish the measures. The issue could not be resolved until at least Israel published draft measures governing infant formula for comment.

The US representative further stressed that the lack of published requirements governing the quality and safety of infant formula, as well as related conformity assessment procedures and labelling provisions, was particularly concerning given the 2003 Remedia incident. It was a difficult position to maintain that infant health in Israel was more protected by keeping the Ministry of Health infant formula requirements secret, rather than by publishing them for the public to review and comment, which was the most basic of all TBT and good regulatory practice principles. It was his delegation's hope that upcoming bilateral discussions with the Ministry of Health in Israel would help to resolve this issue in the near future.

The representative of Israel recalled the highly sensitive nature of the issue in his country. He appreciated the willingness of the United States to discuss the issue bilaterally with Israel's health authorities and was hopeful that this bilateral process would facilitate the prompt resolution of this matter.

The representative of the United States reiterated his delegation's concerns about the fact that a draft regulation on measures related to infant formula had not yet been published by Israel, nor had it been notified to the WTO. US industry continued to have concerns that Israel's unpublished requirements for infant formula were discriminatory against imports and unduly costly, burdensome, and unpredictable. Israel denied these allegations, yet refused to publish the measures. He stressed that the issue could not be resolved until Israel published draft measures governing infant formula for comment.

The lack of published requirements governing the quality and safety of infant formula, as well as related conformity assessment procedures and labelling provisions, was of particular concern given the 2003 Remedia incident. It was a difficult position to maintain that infant health in Israel was more protected by keeping the Ministry of Health infant formula requirements secret, rather than by publishing them for the public to review and comment, which was perhaps the most basic of all TBT and good regulatory practice principles. A promising resolution of this issue had appeared to be near this summer, and Israeli authorities were urged to resume working with industry to resolve this issue in the near term.

The representative of Israel pointed out that, due to grave health problems caused by deficient imported infant formula, the Ministry of Health had been forced to reconsider the import system in order to ensure the health and safety of infant foods. She highlighted that the issue was sensitive and important to Israel and renewed her delegation's invitation to the United States to engage with Israel at bilateral expert level in order to find an agreed solution to the issue.

The representative of the United States recalled that his delegation had expressed concerns about the infant formula regime in Israel at the last several meetings of the Committee. His delegation's understanding was that Israel’s Ministry of Health was working with stakeholders on a revised infant formula regulation that would set out requirements for the sale of infant formula in Israel, and that the Israeli Knesset intended to fast-track its passage. He sought further information on the status of those efforts and urged Israel to continue working with stakeholders to resolve this issue.

The representative of Israel confirmed that internal consultations were on-going between various Israeli authorities, regulators and stakeholders in order to address this issue and find an agreed solution to the concern of the United States. She recalled that in light of grave public health incidents following imports of infant food, the issue was sensitive. Israel remained available for further consultation on this issue with the United States on a bilateral basis.

The representative of the United States recalled that his delegation had expressed concerns on the infant formula regime in Israel at the past two meetings of the Committee. He stressed that US infant formula manufacturers were willing to comply with regulations that were published, treated all producers equally, were clear and consistent and based on science. His delegation's understanding was that the Government of Israel was considering the promulgation of new rules. However, reports suggested that the new regulations would not address the expressed concerns, particularly with respect to consistent application to all infant formula entering the Israeli market. He sought further information on the issue and invited Israel to notify any proposed regulations to the WTO.

The representative of Israel said that in light of grave public health incidents following imports of infant food, the issue was sensitive. Bilateral contacts were on-going between various Israeli authorities, regulators and different stakeholders in order to find an agreed solution to the concern of the United States.

The representative of the United States noted that since the July 2007 meeting of the TBT Committee, when the United States had first raised the issue, the United States had held two meetings with Israeli officials to discuss Israel's infant formula requirements and its failure to provide copies of its regulations. The United States understood the sensitivity of the issue in Israel and welcomed Israel's recent effort to provide the written guidance document used by the Israeli Ministry of Health to regulate imported infant formula and to clarify that there were no regulations currently in place. Regrettably, the information provided by Israel had served to confirm the problems the US industry was facing in the Israeli market.

Principally, this was about a lack of transparency and differential treatment. There was no published information on nutrient composition standards or Ministry of Health requirements for issuing import approvals or licences for infant formula. Moreover, the United States was of the understanding that these requirements often changed. In addition, Israel maintained discriminatory testing requirements, fees, and labelling rules for infant formula in favour of domestic producers. For instance, it was the US understanding that each batch of imported infant formula had to undergo 12 different laboratory tests in an Israeli government laboratory whereas domestic producers could perform their own tests, only needed to do so once each quarter, and could self declare the test results to the Ministry of Health. Furthermore, while Israeli authorities had to approve all labels with nutritional claims on imported products, no pre-marketing approval was required for domestic products and there was no real post-market surveillance in place. US infant formula manufacturers were willing to comply with regulations that were published, treated all producers in the same way, were clear and consistent and based on sound science. The representative of the United States urged Israel to continue and expand its dialogue with interested parties as it developed its regulations on infant formula, and to notify any proposal to the WTO.

The representative of Israel informed WTO Members that up until two years ago there had been no particular treatment of imported infant food and the authorities relied on quality certificates issued by the exporting countries. Due to specific and grave health problems caused by deficient imported infant formula, the Israeli Ministry of Health had been forced to rethink the import system in order to ensure the health and safety of infant food. The regulation which the US delegation was referring to was being finalized by Israeli health authorities. Following the concern expressed by the United States, Israel had provided the United States on 16 October 2007 with a document containing guidelines for importers so as to make the import process predictable and transparent.

The representative of the United States raised concerns with respect to Israeli Ministry of Health regulations governing the sale of infant formula. He pointed out that the US TBT Enquiry Point had sent two separate requests on 10 April and 15 May 2007 for copies of all relevant Israeli Ministry of Health regulations on the sale of infant formula, as well as related information on infant formula laboratory testing, renewal of infant formula product licences and administrative fees, but Israel had not provided a response. He noted that US industry had alleged that Israel's regulations on infant formula unfairly discriminated against imports, that the documentation requirements for imported infant formula frequently changed without prior notice or publication to importers, and that no public written criteria governing the approval of infant formula existed.

The representative of Israel took note of the concerns raised.