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: bertrand.dagallier@oecd.org