OECD Bio&Food safety work: 2 programmes Aim: Help to address human health and environmental safety issues, through science-based risk assessment, for products of modern biotechnology (G.E.O.s): plants, animals, micro-organisms 1) ENVIRONMENTAL safety of GEOs (biosafety) Working Group for the Harmonisation of Regulatory Oversight in Biotechnology 2)FOODS/FEEDS derived from GEOs Task Force for the Safety of Novel Foods and Feeds These groups are composed of bio/food safety National Authorities : regulators, risk assessors & experts, (and observers from Organisations) 1
Consensus documents: Tools for risk assessment Environmental Safety Food/Feed Safety Consensus Documents Consensus Documents On which features should my Is this new food-feed as safe as its environmental RA be based on? conventional counterpart? OECD docs collate key composition OECD docs provide info. on what elements on foods and feeds issued should be considered for risk from G.E. organisms, with compiled assessment of G.E. organisms to be data, for possible comparison. released in the environment. The elements are considered --and The elements are considered --and completed-- at national level. completed-- at national level. Scientific information reference, internationally recognised, a common basis However NOT prescriptive (= not a compulsory standard) 2
CROP PLANTS BIOSAFETY FOOD/FEED Alfalfa Overview of OECD Barley Consensus Documents Cassava Plant species (August 2016) Cowpea in progress Cotton • Fruits Common bean • Mushrooms Grain sorghum • Crop Plants • (Forest & plantation Trees: biosafety only) Maize under revision under revision Brassica spp. Canola Oilseed rape Rev. 2012 Rev. 2011 Peppers Potato FRUITS BIOSAFETY FOOD/FEED Rice Rev. 2016 under revision Apple in progress in progress Soybean Rev. 2012 Bananas & plantains Pumpkins Papaya Sugar beet Stone fruits (e.g. plum) Sugarcane MUSHROOMS BIOSAFETY FOOD/FEED Sunflower Sweet potato Cultivated mushroom Tomato in progress Oyster mushroom Wheat under revision
OECD Consensus documents for novel food and feed safety assessment • OECD Novel Food & Feed Safety programme since 1999 • 1990-2000: Basic principles of " substantial equivalence " and " comparative approach " for safety assessment elaborated by FAO , WHO , and OECD • Practical approach: to compare the critical components of the species: key nutrients, anti-nutrients, toxicants, (allergens, other elements) between G.E.Os and conventional crops. • 2000-2003: The Codex Alimentarius Commission developed principles and guidelines for foods derived from G.E.Os (+ 2008 Annexes on G.E.O.s for nutritional/health benefits, and safety assessment in LLP situation in food) • OECD Consensus Documents on composition since 2001. Collate science-based information for use during RA of a particular food/feed product. Reference for comparison. 4
Example: RICE composition document (rev. 2016) Terminology I. Background: cultivated rice species, production and consumption, processes, uses, appropriate comparators, breeding characteristics II. Nutrients a) Key nutrients in rice products for food use: C ARBOHYDRATES P ROTEIN L IPIDS M INERALS V ITAMINS b) Key nutrients in rice products for feed use III. Other constituents a) Anti-nutrients and toxicants: Phytic acid Trypsin inhibitors Lectins … b) Allergens: 14-16 kDa proteins 33-kDa protein IV. Suggested constituents to be analysed related to food use V. Suggested constituents to be analysed related to feed use 5
Table example: mineral content (1) Table 10a. Mineral content in paddy rice Paddy rice Heuzé, Tran Juliano Data ILSI-CCDB and Hassoun in NRC and (2014) b source Feedipedia (1982) Bechtel (1985) a (2015) MINERAL range mean range mean range mean Macro-minerals (mg/g dry matter) Calcium 0.1-0.9 0.32 0.25-0.43 0.6 0.2-1.5 0.7 Magnesium 0.7-1.7 1.0 0.3-1.4 1.5 Phosphorus 2.0-4.5 2.89 2.49-3.35 2.9 1.9-4.7 3.2 Potassium 1.7-4.3 2.8 1.9-3.5 3.6 Silicon 12.6 Sulfur 0.5-1.9 0.5 Micro- minerals (μg/g dry matter) Copper 2-13 3 3.0 Iron 16-70 56.4 36.3-74.2 53 57.0 Manganese 20-109 82 46-117 20.0 Sodium 62-942 300 0-1000 600 Zinc 2.0-36 14 17.0 Notes: a. Data from Juliano and Bechtel are presented on a fresh weight basis; values at 14% moisture in the literature were converted to those at % dry matter. b. The data are obtained from measurements using an indica rice variety 6
Table example: mineral content (2) Table 10b. Mineral content in brown rice and other rice milling fractions Poli-shings Brown rice Milled rice Hull Bran Germ Juliano Juliano Juliano Juliano Juliano Juliano Data USDA USDA and Bech USDA and and Bechtel and Bechtel and Becht and Bechtel source (2014) (2014) tel (1985) (2014) Bechtel (1985) (1985) a (1985) a el (1985) a (1985) a a a MINERAL range mean range mean range range mean range range Macro-minerals (mg/g dry matter) Calcium 0.1-0.6 0.32 0.1-0.3 0.12 0.7-1.5 0.3-1.4 0.61 0.2-1.2 0.6-0.8 Magnesium 0.2-1.7 1.61 0.2-0.6 0.29 0.3 5.8-15.1 8.32 5-15 7-8 Phosphorus 2.0-5.0 3.36 0.9-1.7 1.11 0.3-0.8 13-29 17.87 12-24 12-26 Potassium 0.7-3.2 2.77 0.8-1.5 0.98 1.7-8.7 12-23 15.82 13-17 8; 13 Silicon 0.7-1.6 0.1-0.5 74-110 3-6 0.5-1.0 1.3; 1.9 Sulfur 0.3-2.2 0.9 0.5 2.0 1.9 Micro- minerals (μg/g dry matter) Copper 1-7 3.13 2-3 2.10 35-45 10-40 7.76 10-40 6-30 Iron 2-60 18.5 2-33 18.8 45-110 100-500 197.5 70-209 50-180 Manganese 2-42 42.24 7-20 11.95 116-337 110-267 151.4 106-140 Sodium 20-395 60 6-100 30 78-960 83-390 50 162-740 trace-160 Zinc 7-33 22.8 7-27 12.9 10-47 50-300 64.3 66-300 20; 70 Notes: a. Data from Juliano and Bechtel are presented on a fresh weight basis; values at 14% moisture in the literature were converted to those at % dry matter. 7
In case of biofortified rice (e.g. golden rice)? Breeding characteristics screened by developers … « 16. Conventional breeding of rice as well as those based on modern biotechnology can include considerations of nutritive improvements with increased content (biofortification) of elements such as pro-vitamin A, iron, or zinc. In these cases, the amonts of these components are specifically evaluated for those objectives. » 8
Suggested elements to be analysed / FOOD use Table 14. Suggested nutritional and compositional parameters to be analysed in rice matrices for food use Paddy rice Parameter or Brown rice Proximates 1 X Total dietary fibre X Vitamins 2 X Amino acids X Fatty acids X Notes: 1. Proximates includes moisture, protein, fat, ash and carbohydrate (calculated). 2. B vitamins, namely thiamine (B1), riboflavin (B2), niacin (B3), pantothenic acid (B5) and Pyridoxine (B6), and E vitamin alpha-tocopherol, are suggested. 9
Suggested elements to be analysed / FEED use Table 15. Suggested nutritional and compositional parameters to be analysed in rice matrices for feed use Straw or Parameter Paddy rice Whole plant Proximates 1 X X Acid detergent fibre X Neutral detergent fibre X Amino acids X Notes: 1. Proximates includes moisture, protein, fat, ash and carbohydrate (calculated). 10
Conclusions • Scientific information/ data contained in the OECD composition documents can be used as reference in food and feed safety assessments • Other international/national documents & databases can be usefully considered • Select/adapt the information from the OECD composition documents (‘global’ documents) to national needs • ‘ Biofortified ’ elements to be considered separately • Suggested parameters to be analysed are… suggestions only! 11
Thank You Consensus Documents & Product database available at: www.oecd.org/biotrack OECD’s Biosafety Team: Peter Kearns; Takahiko Nikaido; Bertrand Dagallier; Mika Hosokawa Contact: bertrand.dagallier@oecd.org 12
Recommend
More recommend
