Session 2 Standards for soft drinks Briefing workshop August 4, 2004 Centre for Science and Environment Existing soft drink standards in India • Exempted from industrial licensing under Industries (Development and Regulation) Act, 1951 • Mandatory regulation under The Fruit Products Order (FPO1955); regulated by Ministry of food processing • Soft drinks standards: o Sweetened aerated water with no fruit juice or fruit pulp or containing less than 10 per cent of fruit juice or fruit pulp under Part II (D) of Fruit Products Order (FPO), 1955; o Carbonated water as defined under item A 01.01 of Appendix B of Prevention of Food Adulteration (PFA) Rules, 1955; o Carbonated Beverages defined under IS 2346-1992 of Bureau of Indian Standards. Centre for Science and Environment Existing soft drink standards Centre for Science and Environment Standards for pesticide residues in soft drinks… • …does not exist. • Rule 65 of PFA regulates pesticides in food. • But food is defined to exclude ‘beverages’. • Sub-section A.01-01 in appendix B defines the standards of quality for non-alcoholic beverages. • But has nothing to say about pesticide residues. • PFA and FPO: The water used for manufacturing the soft drink should be ‘Potable’. But has not defined what is potable. Centre for Science and Environment Difference in results: CSE lab vs. Others • CSE Result: 11 - 70 times higher than multiple residues standard of bottle water • CFRTI: 1.2 - 5.2 times higher • CFL: 1.6 - 5.2 times higher • CPCB: 3.1 – 7.2 times higher • Shriram Lab: 17 – 419 times higher o Different batches o Manufactured during different time period o Tested in different labs Centre for Science and Environment Differences in result: JPC verdict • In view of the fact that these labs did not test identical samples…the quantitative results reported by them cannot be compared. • The Committee however find that the CSE findings are correct…. Centre for Science and Environment Are soft drinks safe? • What is safe? What government lab found safe? CSE lab found unsafe? Or Sriram lab unsafe???? • The answer to this question will also provide the answer for: what should be the pesticide standards for soft drinks. Centre for Science and Environment Safety not about large numbers • Pesticides are deadly. Invisible exposure – over time, in small (tiny) doses – leads to chronic health effects. • Immunosuppressive effect – triggers diseases like cancer or asthma. • Persistent build up in our bodies – lindane for instance is a potent carcinogen. • Pesticide risk management is all about managing and minimising tiny exposures. Centre for Science and Environment Defining safety • Safety is all about meeting and adhering to a given standard. • Safety is about managing the poison-nutrition trade-off (we ingest poison to get some nutrition..) • But this poison must be within safe exposures. Therefore, safety requires setting standards for the food basket. Centre for Science and Environment Politics of clubbing of soft drinks and juices • Politics of regulations: widen the scope of the regulation so that it is: • A. impractical and unfeasible; • B. impossible to implement; • C. lax and weak. • By clubbing all water based beverages into one regulation that is exactly what happened. The fruit juice, malt beverage clubbed together with coke and pepsi. Centre for Science and Environment Take heavy metal norms: • Companies already meet the stringent heavy metal norms in their products (see Annexure 3). • But they want lax standards. Asking for Juice standards set by CODEX. • Mercury (highly toxic): • In drinking water: 1 ppb • In juices: 1 ppm (1000 times higher) • Same issue in bacterial plate count: • In water based drinks: 100/250 ml • In barley and malt drinks: 5000/250 ml • How much should be allowed in soft drinks? Cannot club significantly different ingredients. Centre for Science and Environment Distinct category exists • Cannot regulate if “significantly different ingredients” • Indian regulations already have a distinct category for soft drinks. Under: Carbonated water as defined under item A 01.01 of Appendix B of PFA Rules, 1955; Sweetened aerated water with no fruit juice or fruit pulp or containing less than 10 per cent of fruit juice or fruit pulp under Part II (D) of Fruit Products Order (FPO), 1955; Carbonated Beverages defined under IS 2346-1992 of Bureau of Indian Standards. • Separate standard for other water based beverages: fruit nectar, synthetic syrups, and fruit juices exist. Can keep as separate categories. Centre for Science and Environment Clubbing juices and soft drinks: a masterstroke • The pesticide residue of juices will be different to soft drinks. Juices are part of the essential diet. They provide nutrition. • Cannot club juices with soft drinks. • Also we can only allow pesticide residue in soft drinks, if we remove some essential food item from our diet. • Can soft drink substitute milk? Can soft drink substitute fruit juices? Centre for Science and Environment 2. Should we set standards for final product Pesticide Heavy metals etc. Soft Drinks Χ √ Cheese (even under PFA) √ √ Butter (even under PFA) √ √ Ice cream (even under PFA) √ √ Baby food √ √ Globally no country has set pesticide standards for soft drinks. WHY?? Centre for Science and Environment Actual exposures? European Union (1996) USA (1996) Above MRL (1.4%) Within MRL (35.6) Free from residues (63%) Within MRL (67.2%) Above MRL (4.8%) Free from residues (28%) India (1965-98) Within MRL (39%) Above MRL (20%) Free from residues (41%) Centre for Science and Environment Source: G S Dhaliwal & Balwinder Singh, 2000: 208 Out side System works. Check..enforce..penalize • • • • • US: 6,523 samples tested and 4% failed; EU: 46,000 samples only 4% failed standards; Canada: 44,000 samples only 2% failed standards. Low MRL set. Strict enforcement. Regular surveillance. Their governments say that pesticides are not a health hazard because the exposure is low. • They do not regulate pesticides in finished products like soft drinks, because they have cleaned up their contamination. We haven’t. Centre for Science and Environment Honey…jam contaminated • Government report: 2001 • Honey: out of 82 samples, 51 per cent contaminated. • Jam…67 per cent contaminated • Jelly…all 12 samples contaminated.. • Baby food (1999) all contaminated. • India has to set standards for processed food+ enforce standards for raw commodities. Centre for Science and Environment How do we set standard for final product? • Globally pesticide standard for processed food are set by following 3 broad principle: o Carry forward principle o Multi-constituent principle o No standard - no residue principle. Centre for Science and Environment Carry-forward principle • Carry-forward the pesticide from raw agricultural commodity to the finished product. • Means that if under the PFA there is a standard for ‘Phorate’ in sugarcane, then the standard for ‘Phorate’ in sugar should be similar to the sugarcane standard. Conversely, if there is no standard for DDT in sugarcane than no residue of DDT should be found in sugar. Centre for Science and Environment Multi-constituent principle • MRL of a finished Products with multiple commodities = Sum of MRLs of various commodities as proportionately present. • Soft Drinks constituents: 10% sugar+1% others+89 % water • (10% of sugar MRL) + (1% of other MRL) + (89% of water MRL) • Calculate norms for soft drinks as finished product… Centre for Science and Environment No standard-no residue principle Law states that: “If an MRL for a chemical is not listed in the standard then there must be no detectable residue of that agricultural chemical in that food”. Therefore, if under the PFA no standard for DDT in sugarcane is mentioned then there must be no detectable residue of DDT in sugar cane. Centre for Science and Environment Pollution Monitoring Laboratory • Soft Drink = 89% water + 10% sugar + 1% [co2+concentrate] Let us take Packaged Drinking Water Standard [in ppb] > Water Sugar CO2+concentrate Final Packaged Drinking Water PFA PFA Packaged Drinking water DDT 0.1 0 0 0.09 Lindane 0.1 0 0 0.09 Malathion 0.1 0 0 0.09 Chlorpyriphos 0.1 0 0 0.09 Centre for Science and Environment Pollution Monitoring Laboratory • Different standards for Soft Drinks derived from different regulatory regimes [in ppb] Indian BIS WHO USEPA Packaged Drinking water DDT Absent [0] 0.9 0 0.09 Lindane Absent [0] 0.27 0.18 0.09 Malathion Absent [0] 810 0 0.09 Chlorpyriphos Absent [0] 27 0 0.09 Centre for Science and Environment Are soft drinks safe? • Different standards for Soft Drinks derived from different regulatory regimes [in ppb] BIS (IS 10500) Drinking water WHO USEPA Packaged Drinking water DDT Absent [0] 0.9 0 0.09 Lindane Absent [0] 0.27 0.18 0.09 Malathion Absent [0] 810 0 0.09 Chlorpyriphos Absent [0] 27 0 0.09 • 100% of CFL/CFTRI/CSE/CPCB samples fail BIS norm Centre for Science and Environment Are soft drinks safe? • Different standards for Soft Drinks derived from different regulatory regimes [in ppb] Indian BIS WHO USEPA Packaged Drinking water DDT Absent [0] 0.9 0 0.09 Lindane Absent [0] 0.27 0.18 0.09 Malathion Absent [0] 810 0 0.09 Chlorpyriphos Absent [0] 27 0 0.09 • 100% of CFL/CFTRI results fail BIS norm • 75% of CFTRI and 58% of CFL results fail WHO norm Centre for Science and Environment Are soft drinks safe? • Different standards for Soft Drinks derived from different regulatory regimes [in ppb] Indian BIS WHO USEPA Packaged Drinking water DDT Absent [0] 0.9 0 0.09 Lindane Absent [0] 0.27 0.18 0.09 Malathion Absent [0] 810 0 0.09 Chlorpyriphos Absent [0] 27 0 0.09 • 100% of CFL/CFTRI results fail BIS norm • 75% of CFTRI and 58% of CFL results fail WHO norm • 100% CSE and CPCB results fail WHO norm Centre for Science and Environment Are soft drinks safe? • Different standards for Soft Drinks derived from different regulatory regimes [in ppb] Indian BIS WHO USEPA Packaged Drinking water DDT Absent [0] 0.9 0 0.09 Lindane Absent [0] 0.27 0.18 0.09 Malathion Absent [0] 810 0 0.09 Chlorpyriphos Absent [0] 27 0 0.09 • 100% of CFL/CFTRI/CSE/CPCB samples fail USEPA norm Centre for Science and Environment Are soft drinks safe? • Different standards for Soft Drinks derived from different regulatory regimes [in ppb] Indian BIS WHO USEPA Packaged Drinking water DDT Absent [0] 0.9 0 0.09 Lindane Absent [0] 0.27 0.18 0.09 Malathion Absent [0] 810 0 0.09 Chlorpyriphos Absent [0] 27 0 0.09 • 100% of all results fail USEPA norm • And obviously all results fail packaged drinking water norms as well. Centre for Science and Environment Soft drinks not safe • CSE said “not safe” because drinks did not meet any set-derived standards • Not only for the tests done by CSE but also for tests done by CFL, CFTRI, CPCB and Shriram lab, Bangalore. Centre for Science and Environment What should be the soft drink standard? • If we use the global practice, then: • As per the PFA there are only 4 pesticides for which standards exists for sugar cane and therefore for sugar used in soft drinks: Atrazin: 0.25 mg/kg Carbofuran: 0.1 mg/kg Phorate: 0.05 mg/kg Simazine: 0.25 mg/kg • Ministry of health has already recommended that water used in soft drink should meet BIS packaged drinking water standard. Centre for Science and Environment What should be the soft drink standard? Inputs Amount (gm) BIS bottle water standard/ MRLs of sugar cane and hence sugar under PFA (ppm) Atrazine Simazine Carbofuran Phorate All other pesticides Water 890 0.0001 0.0001 0.0001 0.0001 0.0001 Sugar 100 0.25 0.25 0.1 0.05 0 Others 10 0 0 0 0 0 0.025 0.025 0.01 0.005 0.00009 Soft Drink Standard Centre for Science and Environment Soft drink standard using global principle and existing Indian standards Atrazin – 0.025 mg/l Simazine – 0.025 mg/l Carbofuran – 0.01 mg/l Phorate – 0.005 mg/l Other individual pesticides: 0.00009 mg/l Total pesticide: 0.00045 mg/l – Note: The total pesticide standard does not include the 4 pesticides listed above. • BUT THERE IS A PROBLEM? 1. 2. 3. 4. 5. 6. Centre for Science and Environment Indian law is about final product • PFA regulates the quality of final product in Appendix B (A.01.01). • PFA also says that contaminants (pesticides) from raw material cannot be carried forward to the final product. • Part XI A (Crop contaminants): defines pesticides as contaminants. • Part XIII A (Carry over of food additives): categorically states that contaminants cannot be carried over from raw material to final product. • In other words, if there are contaminants in any raw material (say sugar), manufacturers have to clean it up in the final product. Centre for Science and Environment Soft drink standards in light of the PFA provisions • There cannot be any carry forward of pesticides to soft drinks from agricultural ingredients. • Therefore, soft drinks will have to meet the existing packaged drinking water standards. o Individual pesticides: 0.0001 mg/l o Total pesticide: 0.0005 mg/l Centre for Science and Environment JPC recommendations on pesticide standards: • Water used in the manufacture of soft drinks must conform with bottle water norms. • Sugar is not the likely source of contamination. Also soft drink manufacturers mentioned before JPC that they have “foolproof process” to select and treat sugar from contaminants. • Set final product standards. “The reason that others have not fixed should not dissuade our law makers…” Centre for Science and Environment Caffeine in soft drinks • Caffeine consumption linked with diseases and disorders such as insomnia, nervousness, anxiety, irritability, and deviations from the normal heart rate. • World regulates caffeine in food for this reason. Centre for Science and Environment Cannot compare caffeine in soft drinks with tea and coffee • Globally caffeine in tea and coffee is never compared with caffeine in soft drinks because of the ‘natural speciation’ of caffeine with tea and coffee, as is the case of ‘natural speciation’ of metals and acids in fruits (iron is apple, citric acid in lemon and oranges etc). • Caffeine is soft drinks is artificially added. • there are no standards for caffeine in tea and coffee, but there are standards for caffeine in soft drinks. Centre for Science and Environment Caffeine in soft drinks • Globally caffeine only permitted in ‘cola dinks’ (China, Canada, Australia, South Africa, Holland, Spain etc.). Allowed till 150 mg/l. Or caffeine-free versions sold. • PFA makes no such distinction. Allows 200 mg/l in all. • Result: In India, caffeine added even in non-cola drinks like PepsiCo’s ‘Mountain Dew’. • Harmful for children, pregnant and lactating women. • Caffeine is addictive. • We cannot allow caffeine in non-cola. • Caffeine standard must be similar to global best norms. • We also need clear warning labels if caffeine added. • Labels needed in regional languages. Centre for Science and Environment JPC recommendations on caffeine • Lower limit from 200 ppm (200 mg/litre) to the global best standard. • Ask for non-caffeinated versions of caffeinated drinks • If above than standard, then label should have health advisory: • “The beverage is not recommended for: – Children – Pregnant or lactating women – Individuals sensitive to caffeine” Centre for Science and Environment Regulate pH (acidity) • Lower pH means high acidity in the body. Regulations for pH do not exist in India. Only South Africa regulates pH at 2.5. • Non-regulation of interest to companies because low pH gives longer shelf-life. pH regulation needed. Water M ilk Beer Nimbu Pani M ango Juice Orange Juice Apple Juice Wine Lime Soft Drinks Hydrochloric Sulphuric Acid 0 2 4 6 8 7 Centre for Science and Environment 10 12 14 What has happened after JPC: BIS • BIS has revised its existing soft drink standards and released it for public comment till August 31. • BIS multi-stakeholder committee considered all issues. • Agreed on “final product” standards for pesticide residues in soft drinks. • Committee discussed contamination through sugar and agreed with JPC recommendations. • Followed the existing provisions of PFA that carry forward is not allowed . • Agreed on: 0.0001 ppm (single pesticide) • 0.0005 ppm (total pesticides) • Bought down caffeine from 200 to 145 mg/l and regulated pH between 2.3 – 8.5. Centre for Science and Environment What has happened after JPC: Ministry of Health • Ministry of Health and Family Welfare issued notification to the effect that the water to be used in manufacturing soft drink should meet packaged drinking water standard. • Has set-up a committee to look at final product standard. • These standards will be mandatory. Centre for Science and Environment