Certificates of Analysis 2017 International Wine Technical Summit Certificates of Analysis Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. June 20, 2017 Paul Huckaba, Bronco Wine Company

Certificates of Analysis Overview: Background FIVS Paper on Certificates of Analysis 3. is Wine an inherently safe product? 4. Are Certificates of analysis necessary? 5. What about Laboratory Data? 6. Summary, and A proposal Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Tbilisi Statement, Principle #01 - AVOID UNNECESSARY ANALYSIS Certificates of Analysis “The Tbilisi Statement” http://ita.doc.gov/td/ocg/wwtg.htm “The ‘Statement on Analytical Methodology and Regulatory Limits’ was adopted to remove unnecessary obstacles to international wine exports. The principles, finalized at the trade group's annual meeting in Tbilisi, Georgia on Aug. 25-26, 2014, were proposed to address a continuing pattern of wine trade barriers. Many countries establish unnecessary rules which delay and add to winery costs, resulting in restricted market access and trade.” (https://www.wineinstitute.org/resources/pressroom/09022014) Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Tbilisi Statement, Principle #01 - AVOID UNNECESSARY ANALYSIS “GOVERNMENTS SHOULD ESTABLISH REGULATORY LIMITS THAT ARE BASED ON RISK, THEREBY AVOIDING UNNECESSARY ANALYSIS.”

Certificates of Analysis In the APEC region, “…the costs of unnecessary testing and certification in the region (were) estimated at 1 billion USD per annum.” Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. $1,000,000,000 USD $?,???,???,??? USD

Certificates of Analysis FIVS paper on Certificates of analysis IWTS Lab Quality group FIVS Scientific and Technical Committee Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. www.fivs.org

Certificates of Analysis Is wine an inherently safe product? A collection of “requested” tests for COAs Appearance Hybrids Stability at -5°C Bacteria, cultured Iron Sucrose Calories Lead Sugar Free Extract Citric Acid Limpidity Titratable Acidity (TA) Color (sensory evaluation) Methanol Total Alcoholic Strength Copper Molecular Sulphur Dioxide (SO2) Total Dry Extract Density pH Total Sugar (Reducing Sugar - Inverted) Ethanol Reducing Sugar Total Sugar Free Sulphur Dioxide (SO2) Remaining Extract Total Sulphur Dioxide (SO2) Fungus, cultured Sorbic Acid Volatile Acidity (VA) Gas Pressure at 20°C Specific Gravity Volume per Bottle Glucose + Fructose (sugars) Stability at 55°C Yeast, cultured Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Certificates of Analysis Is wine an inherently safe product? We can group tests into 6 main categories Health and Safety – (e.g., Total SO2) Wine Quality and Legality – (e.g., Ethanol, Methanol, VA) Additive Levels – (e.g., Sorbic Acid, Citric Acid) Microbiological – (e.g., Yeast, Bacteria, Mold, “Fungus”) Physical Characteristics – (e.g., Stability, Color, Limpidity) Typical Wine Parameters – (e.g., pH, Sugars) Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Certificates of Analysis Is wine an inherently safe product? “Health and Safety” Sulfur Dioxide (SO2) Methanol Heavy Metals Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Concentrations are too low for concern

Certificates of Analysis Is wine an inherently safe product? “Wine Quality and Legality” Ethanol Gas Pressure Methanol Volatile acidity Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Quality and legality don’t affect safety

Certificates of Analysis Is wine an inherently safe product? “Additive Levels” Mostly Grape-Derived Difficult to determine added amount Good Manufacturing Practice (GMP) usage Minimal usage No risk, Based on jecfa evaluations Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Concentrations are too low for concern

Certificates of Analysis Is wine an inherently safe product? “Microbiological” Yeast/fungus, Bacteria (Quality only) Pathogens (E. Coli, Salmonella) “Microbiologically, wine is a low food safety risk consumer product” (https://www.bio-conferences.org/articles/bioconf/pdf/2016/02/bioconf-oiv2016_04003.pdf) Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Pathogens don’t survive in wine

Certificates of Analysis Is wine an inherently safe product? “Physical Characteristics” Color, limpidity (clarity), Stability Subjective descriptors Can vary based on tradition, culture, fashion, or style. Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Characteristics of wine don’t affect safety

Certificates of Analysis Is wine an inherently safe product? “Typical Wine Parameters” pH, Acidity, sugars, density, etc. Grape-Based, so a narrow range of values Additions – more of the same? Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Safe in the grapE? Safe in the wine!

Certificates of Analysis Are certificates of analysis necessary? Certificate of analysis tests Are either: Not related to health and safety Declared on the bottle Unlikely to reach harmful levels in wines made using Good Enological Practice So…are they necessary? Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Certificates of Analysis Are certificates of analysis necessary? What if your country decides they are? Have Clearly defined requirements Have Acceptable data quality Have Results Within tolerance, plus uncertainty Next up: laboratory data Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Certificates of Analysis What about laboratory data? 1. Clearly defined requirements --What exactly is being regulated? For example, “Sugars” the quantity of compounds capable of reducing an alkaline cupric solution the combined quantities of saccharides and disaccharides the amount of fermentable sugars present the amount of glucose, fructose and sucrose present (Sacarose/sacarosa/saccharose?) Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Certificates of Analysis What about laboratory data? 2. Acceptable data quality? Laboratory data quality programs Certification/accreditation ISO 17025 – A single, International standard Enforcement labs Producer or third-party Labs Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Both adhere to the same quality standard—ISO 17025, and the data should be widely accepted.

Is this the “Right Answer”? Certificates of Analysis What about laboratory data? 3. Within tolerance, plus uncertainty Is this the “Right Answer”? Small variations in temperature + Analyst technique + Analyte Stability + Lots of other little things Uncertainty Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Certificates of Analysis What is Uncertainty? Uncertainty of Measure – Codex Alimentarius’ Estimates “it would be reasonable to anticipate that the (expanded) uncertainties reported by laboratories would be approximately the following”:1 Nominal Concentration Typical Expanded Uncertainty Expected Range of Results* 100 g/100g 4% 96 to 104 g/100g 10 g/100g 5% 9.5 to 10.5 g/100g 1 g/100g 8% 0.92 to 1.08 g/100g 1 g/kg 11% 0.89 to 1.11 g/kg 100 mg/kg 16% 84 to 116 mg/kg 10 mg/kg 22% 7.8 to 12.2 mg/kg 1 mg/kg 32% 0.68 to 1.32 mg/kg < 100 μg/kg 44% 0.56 x concentration to 1.44 x concentration in ug/kg Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. * this effectively means that values falling within these ranges may be regarded as being of the same analytical population. 1 Codex Alimentarius Commission (2011). Report of the Thirty Second Session of the Codex Committee On Methods Of Analysis And Sampling, Budapest.

Certificates of Analysis What is Uncertainty? Uncertainty of Measure – Codex Alimentarius’ application “…where the test result is compared against the specification consisting of a maximum level. It illustrates how the concept of measurement uncertainty could be taken into account when interpreting analytical results on a tested sample. This diagram demonstrates the importance of defining clear guidelines to allow unambiguous and objective interpretation of analytical results with respect to their measurement uncertainties.” 1 Situation i The analytical result minus the expanded measurement uncertainty exceeds the maximum level. The result indicates that the measured analyte in the test sample is above the specification. Situation ii The analytical result exceeds the maximum level by less than the expanded measurement uncertainty. Situation iii The analytical result is less than the maximum level by less than the expanded measurement uncertainty. Situation iv The analytical result is less than the maximum level by more than the expanded measurement uncertainty. Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina. Codex Alimentarius Commission (2011). Report of the Thirty Second Session of the Codex Committee On Methods Of Analysis And Sampling, Budapest.

Certificates of Analysis Summary Wine is inherently safe COAs may not be necessary When COAs are required: Define the analyte well Ensure quality results Consider uncertainty Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Certificates of Analysis A proposal Could we follow the lead of the Apec Wine Regulatory Forum? Current project: To identify the current requirements for Certificates of Analysis among APEC economies To consider the precise purpose these serve and whether they are essential To contemplate a simplification by the elimination of Certificates of Analysis altogether or some progress towards harmonization for those economies where that may not be possible “To increase wine production, to expand trade, and to create jobs in the region, we commit to eliminating unnecessary export certification for wine by 2018 and instruct officials to advance this work.” 2014 Joint Ministerial Statement Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Certificates of Analysis Group Discussion: Which authority in your country mandates the tests required on your certificates of analysis? Are the certificates of analysis prescribed by law? What is the process for requesting changes to the tests required? Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.

Gallo produces amazing wines in every category, to suit every taste Gallo produces amazing wines in every category, to suit every taste.  Gallo also imports wines from nine wine growing countries in the world.  Gallo’s wine portfolio totals over 60 unique brands: Barefoot is the number 1 wine in the US and has introduced many new wine drinkers to the wine category. In 2011 alone we updated the Bella Sera Label and updated the Redwood Creek Label. Last year we also introduced The Naked Grape from California and Bodega Elena from Argentina.