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)
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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
Consensus documents: Tools for risk assessment
Is this new food-feed as safe as its conventional counterpart?
OECD docs collate key composition elements on foods and feeds issued from G.E. organisms, with compiled data, for possible comparison.
The elements are considered --and completed-- at national level.
Environmental Safety Consensus Documents
Food/Feed Safety
Consensus Documents
On which features should my environmental RA be based on?
OECD docs provide info. on what should be considered for risk assessment of G.E. organisms to be released in the environment.
The elements are considered --and completed-- at national level.
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Scientific information reference, internationally recognised, a common basis
However NOT prescriptive (= not a compulsory standard)
CROP PLANTS BIOSAFETY FOOD/FEED
Alfalfa
Barley
Cassava
Cowpea in progress
Cotton
Common bean
Grain sorghum
Maize under revision under revision
Oilseed rape Brassica spp. Rev. 2012
Canola Rev. 2011
Peppers
Potato
Rice Rev. 2016 under revision
Soybean Rev. 2012
Pumpkins
Sugar beet
Sugarcane
Sunflower
Sweet potato Tomato in progress
Wheat
under revision
Overview of OECD Consensus Documents Plant species (August 2016)
• Fruits • Mushrooms • Crop Plants • (Forest & plantation Trees: biosafety only)
FRUITS BIOSAFETY FOOD/FEED
Apple in progress in progress
Bananas & plantains Papaya Stone fruits (e.g. plum)
MUSHROOMS BIOSAFETY FOOD/FEED
Cultivated mushroom Oyster mushroom
• OECD Novel Food & Feed Safety programme since 1999
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OECD Consensus documents for
novel food and feed safety assessment
• 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.
Example: RICE composition document (rev. 2016)
Terminology I. Background: cultivated rice species, production and consumption,
processes, uses, appropriate comparators, breeding characteristics
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II. Nutrients a) Key nutrients in rice products for food use: CARBOHYDRATES
PROTEIN LIPIDS MINERALS VITAMINS
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
Table example: mineral content (1)
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Paddy rice
Data
source
Juliano
and
Bechtel (1985) a
ILSI-CCDB
(2014) b
Heuzé, Tran
and Hassoun in
Feedipedia
(2015)
NRC
(1982)
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
Table 10a. Mineral content in paddy rice
Table example: mineral content (2)
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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.
Table 10b. Mineral content in brown rice and other rice milling fractions
Brown rice Milled rice Hull Bran Germ Poli-shings
Data
source
Juliano
and Bechtel
(1985) a
USDA
(2014)
Juliano
and Bechtel
(1985) a
USDA
(2014)
Juliano
and Bech
tel (1985) a
Juliano
and Becht
el (1985) a
USDA
(2014)
Juliano
and Bechtel
(1985) a
Juliano
and
Bechtel (1985) 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
In case of biofortified rice (e.g. golden rice)?
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… « 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. »
Breeding characteristics screened by developers
Suggested elements to be analysed / FOOD use
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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.
Table 14. Suggested nutritional and compositional parameters to be analysed in
rice matrices for food use
Parameter
Paddy rice
or Brown rice
Proximates1 X
Total dietary fibre X
Vitamins2 X
Amino acids X
Fatty acids X
Suggested elements to be analysed / FEED use
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Notes: 1. Proximates includes moisture, protein, fat, ash and carbohydrate (calculated).
Table 15. Suggested nutritional and compositional parameters to be analysed in
rice matrices for feed use
Parameter Paddy rice Straw or
Whole plant
Proximates1 X X
Acid detergent fibre X
Neutral detergent fibre X
Amino acids X
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!
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Consensus Documents &
Product database available at:
www.oecd.org/biotrack
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Thank You
OECD’s Biosafety Team: Peter Kearns; Takahiko Nikaido; Bertrand Dagallier; Mika Hosokawa
Contact: [email protected]
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