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Risk Assessment generated by a regulatory process
(RA)
published: 18 Sep 2008
last updated: 26 Mar 2025
Determination for the Safety Assessment of Cotton 1445 for Direct Use as Food, Feed and for Processing
EN
05 Dec 2008
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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MON-Ø1445-2 - Roundup Ready™ cotton| Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to herbicides (Glyphosate)
- DA-BPI Biotechnology Office [ English ]
EN
The data and analyses on the potential for toxicity or allergenicity of the CP4 EPSPS or NPT II proteins support the conclusions that neither protein is derived from an allergenic or toxic food source nor exhibits the characteristics of known protein allergens. CP4 EPSPS does not exhibit sequence similarity with known toxins or allergens. Furthermore, the CP4 EPSPS and NPT II proteins are present in relatively low abundance in cottonseed and both have been demonstrated to be degraded in conditions that mimic human digestion.
PTII protein was shown to degrade rapidly under simulated mammalian digestive conditions and cause no deleterious effects when administered in an acute gavage mouse study. The safety of CP4EPSPS was evaluated by physical and functional characteristics. The expressed protein is rapidly digested and is not toxic to acutely gavaged mice.
Refined cottonseed oil and cellulose from processed linters are the two components of cotton used in human foods. Refined oil is generally accepted as being devoid of protein. CP4 EPSPS protein was detected in raw linters but could not be detected in linters after the first processing step. (Sims et al 1996). From these data it can be concluded that the food products derived from glyphosate-tolerant cotton should pose no greater threat as a source of allergic reaction than food products from conventional cotton.
Analysis on fat, protein, moisture and ash have shown that seed from Roundup ready cotton is compositionally equivalent to and as nutritious as, seed from the parental cotton variety and other commercial cotton varieties Analysis have shown also that the levels of fatty from Roundup ready cotton were comparable to the parental cotton variety and other commercial cotton varieties.
Levels of toxicant cyclopropenoid fatty acids were determined for cottonseed. No significant differences were detected between Cotton 1445 and control. Analysis have shown that he levels of natural toxicants and anti-nutrients form roundup ready cotton were comparable to the parental cotton variety and other commercial varieties.
EN
PTII protein was shown to degrade rapidly under simulated mammalian digestive conditions and cause no deleterious effects when administered in an acute gavage mouse study. The safety of CP4EPSPS was evaluated by physical and functional characteristics. The expressed protein is rapidly digested and is not toxic to acutely gavaged mice.
Refined cottonseed oil and cellulose from processed linters are the two components of cotton used in human foods. Refined oil is generally accepted as being devoid of protein. CP4 EPSPS protein was detected in raw linters but could not be detected in linters after the first processing step. (Sims et al 1996). From these data it can be concluded that the food products derived from glyphosate-tolerant cotton should pose no greater threat as a source of allergic reaction than food products from conventional cotton.
Analysis on fat, protein, moisture and ash have shown that seed from Roundup ready cotton is compositionally equivalent to and as nutritious as, seed from the parental cotton variety and other commercial cotton varieties Analysis have shown also that the levels of fatty from Roundup ready cotton were comparable to the parental cotton variety and other commercial cotton varieties.
Levels of toxicant cyclopropenoid fatty acids were determined for cottonseed. No significant differences were detected between Cotton 1445 and control. Analysis have shown that he levels of natural toxicants and anti-nutrients form roundup ready cotton were comparable to the parental cotton variety and other commercial varieties.
CP4-EPSPS does not possess the characteristics of known protein allergens and is not toxic. Compositional analyses demonstrated no significant differences between glyphosate-tolerant cotton and its conventional counterpart. Cottonseed oil and linters derived from glyphosate-tolerant cotton do not raise any public health and safety concerns. Round up Ready cotton are non- toxic and unlikely to have allergenic potential.
EN
Cotton MON 1445 applied for direct use is safe for human food, livestock feed and for processing as its conventional counterparts.
EN
A biosafety permit for Cotton MON 1445 and all progenies derived from crosses of the product with any conventionally-bred cotton and cotton containing approved-biotech events for direct use as food, feed or for processing was issued to Monsanto Philippines Inc. Cotton MON 1445 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
Cotton MON 1445 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
EN
This application is not for propagation of Cotton MON 1445. This LMO will be directly used for food, feed and for processing.
EN
Qualitative diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR.
EN
Yes
Yes
Yes
Yes
Yes
Cotton MON 1445 is intended for direct use as food and feed and for processing.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of Cotton MON 1445.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members and DA Regulatory Agencies during the evaluation of Cotton MON 1445.
- OECD Consensus Document on Cotton [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |