1. Regulating Winemaking Practice Additions in a Rapidly Evolving, Global Market Greg Hodson 7 th May, 2015

2. Agenda Today’s winemaking environment Winemaking practices and additions: What regulatory approach is best for sustained market growth? GMP: A possible way forward – Benefits – Arguments and counter arguments – Codex Alimentarius’ approach

3. Today’s Winemaking Environment The market for wine has globalized – fast! This change has generally outpaced regulatory development in many countries Wine does not fit comfortably into standard food regulatory approaches Result? Differing regulatory limits and approaches to testing in different markets These have caused unnecessary obstacles to trade and increased costs of doing business but provide no additional benefits to stakeholders – consumers, producers and regulators.

4. Regulatory needs for sustained market growth Today’s winemaking environment needs a harmonized regulatory approach that will: o Provide guarantees to consumers concerning the safety of the product o Provide flexibility to producers to deal with rapidly changing circumstances o Eradicate needless trade barriers globally and o Reduce the burden of unnecessary and problematic enforcement activity on the part of the competent authorities.

5. Consumer needs for sustained market growth 1.Maintaining product safety – Wine is acknowledged to be a low risk product – Most substances used to treat wine are natural components of wine grapes These substances are reviewed by JECFA with a ‘no known public health risk’ opinion – A few other treatment are not naturally found in wine These substances are reviewed by JECFA, very few have a numerical Acceptable Daily Intake (ADI) value

6. Consumer needs for sustained market growth 1.Maintaining product safety – This means that for a large majority of permitted wine treatment substances: there are no safety concerns and for the small number of substances where a limit is appropriate, the ADI recommended by JECFA can be used to establish usage levels to ensure the safety of the end product. In practice, there should be no food safety concerns surrounding any given approach to the regulation of winemaking practices for international trade purposes.

7. Industry needs for sustained market growth 2.Providing flexibility – Producer flexibility in the light of rapid evolution: Climate change Developing wine knowledge Global market and consumer demands The ideal regulatory framework for winemaking practice additions should provide as much flexibility to producers as possible, so that they can more easily adapt to the constantly changing circumstances that exist in a globalized market.

8. Industry needs for sustained market growth 3.National flexibility – freedom to make provisions specific to their own producers, in order to develop and/or protect perceived advantages in the marketplace relating to quality, culture or heritage – the perceived status of products, the use of certain winemaking practices can be used as the basis for national taxation policy These programs can be implemented without the creation of trade barriers at the international level, and it is important that a global system of regulation for wine production allows flexibility at the national level for this sort of regulation to continue.

9. Industry needs for sustained market growth 4.Eradicating trade barriers Unnecessary and Problematic Enforcement – Some Limits are Incapable of Meaningful Enforcement in International Trade – Some Numerical Limits for Winemaking Practices are Open to Misinterpretation Wine trade is hampered when consignments of wine are delayed or denied market entry while perceived breaches of national winemaking regulations are investigated. Where those rules do not relate to any meaningful public health or consumer protection risk or interest, the result is enormous cost without any benefits for the wine trade or consumers in the destination country.

10. Regulator needs for sustained market growth? In line with principles of Better Regulation – Subsidiarity and Proportionality. Regulations should: Add value for the public Be designed for efficient and effective enforcement Have the lowest financial impacts for business – Simplification – Reduction in the administrative burden of regulations – Impacts should be favourable

11. Regulator needs for sustained market growth A practical output of the first principle endorsed by FIVS in 2013 – “Establish only necessary regulatory limits” And with the First Principle of the WWTG Tbilisi Statement: – “Governments should establish regulatory limits that are based on risk, thereby avoiding unnecessary analysis.”

12. A possible way forward Good Manufacturing Practices (GMP) – Codex Alimentarius Commission defines GMP: the quantity of the additive added to food does not exceed the amount reasonably required to accomplish its intended physical nutritional or other technical effect in food; the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technological effect in the food itself, is reduced to the extent reasonably possible; the additive is of appropriate food grade quality and is prepared and handled in the same way as a food ingredient. Food grade quality is achieved by compliance with the specifications as a whole and not merely with individual criteria in terms of safety

13. A possible way forward The benefits of GMP – Product safety Based on risk and International scientific expert committee evaluations – Producer Flexibility Allows producers to adapt to changing climates and circumstances in a timely manner Reduces regulatory costs and time Still allows nations to tailor individual approach

14. A possible way forward The benefits of GMP – Eradication of Trade Barriers Fewer numerical limits to be misinterpreted and misapplied Not inconsistent with previous harmonization efforts: EU Common Market Organization (CMO) for wine, and the WWTG ‘Mutual Acceptance Agreement for Oenological Practices’ – Enforcement Renders enforcement of specific levels unnecessary

15. A possible way forward Responses to arguments against GMP – “Usage According to GMP is no Limit at all” GMP is a de facto Limit, more conservative than most numerical limits Usage of winemaking treatment agents is limited by cost and by product quality concerns – GMP will result in consumer deception But good wine cannot be made from bad grapes The consumer is presented in the marketplace with a good wine that has no public safety issues associated, and can choose freely

16. A possible way forward Responses to arguments against GMP – GMP will result in reduced product quality quality of wine will not suffer but will rather benefit from the ability to use winemaking treatments as needed – GMP limits by their very nature cannot be enforced for many winemaking treatments where numerical limits are applied, enforcement by analysis is impossible

17. GMP and Codex Alimentarius It is worth noting that the general approach of the Codex Committee on Food Additives (CCFA) is to assign a maximum use level of “GMP” for an additive if the FAO/WHO Joint Expert Committee on Food Additives (JECFA) has assigned a non-numerical acceptable daily intake (ADI) (e.g., “not specified”), signifying no public safety concerns. However, CCFA typically establishes a numerical maximum use level for an additive if JECFA has assigned a numerical ADI for that additive.

18. Questions?