1. The Regulatory Environment Legislation, Regulation and Enforcement Issues for Salt Iodization R. Houston – MOST/USAID Moldova Monitoring workshop April 2004

2. Ingredients Laws Regulations Implementing agencies (ie Customs, Sanitary Epidemiologic Service) Laboratories Salt industry representatives Politicians and policy makers

3. LEGISLATION Mandates iodization Empowers MOH to set standards Defines lines of authority and investigative powers Provides for incentives and punishment for non- compliance Defines licensing or registration requirements Addresses packaging and labeling Corrects unfavorable tax (ie for iodate)

4. REGULATIONS Define implementation procedures Define standards Set iodine levels Specify storage requirements Define packaging and labeling requirements Require quality assurance and record keeping Establish import clearance procedures

5. Customs ? Are the procedures for checking iodized salt at the border clear and realistic? What sampling methods are defined? How are discrepancies between certificate of conformity and customs results to be resolved? How are rejected shipments managed?

6. Wholesale and retail inspection ? Are the procedures for checking iodized salt at wholesale and retail levels clear and realistic? Are resources sufficient to provide adequate sampling? How are discrepancies between inspection results and stated iodine content to be resolved? Are there procedures defining how rejected samples are to be managed?

7. Laboratory Issues ? Do the regulations establish standards laboratories for salt analysis? Are there procedures for using an external standards lab (for either all analyses or for confirmation)? Are sample handling methods well defined (ie for use as evidence)? Are the lines of authority for managing lab results clear?

8. Industry perspective ? Are importers aware of, and in agreement with the existing laws and regulations? Have importers had difficulty with either customs or producers regarding conformity? Do industry representatives feel inspection and enforcement procedures are fair and effective? Is industry concerned about regulatory provisions regarding incentives or dis- incentives for salt iodization ?

9. Standards Codex standards for food grade salt Packaging standards Size Material Repackaging Labeling standards Contents Producer Lot number Expiration date Government logo Storage requirements Conditions FIFO National standards for iodized salt

10. Other Issues Conformity of laws and regulations for iodized salt, with other food laws Synchronization of iodized salt regulations with regulations for other fortified products Agreement on tax issues for products involving a public health benefit