RESUMO
In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Directorate requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The genetically modified, glufosinate-tolerant oilseed rape lines MS8, RF3 and MS8 x RF3 (Notification C/BE/96/01) are approved under Directive 2001/18/EC for import and processing for feed and industrial purposes since 26 March 2007 (Commission Decision 2007/232/EC). In addition, processed oil from genetically modified oilseed rape derived from MS8, RF3 and MS8 x RF3 were notified as existing food according to Art. 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients in November 1999. Existing feed and feed products containing, consisting of or produced from MS8, RF3 and MS8 x RF3 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed on the market in January 2000. An application for renewal of the authorisation for continued marketing of existing food, food ingredients and feed materials produced from MS8, RF3 and MS8 x RF3 was submitted within the framework of Regulation (EC) No 1829/2003 in June 2007 (EFSA/GMO/RX/MS8/RF3). In addition, an application covering food containing or consisting of, and food produced from or containing ingredients produced from oilseed rape MS8, RF3 and MS8 x RF3 (with the exception of processed oil) was delivered by Bayer CropScience in June 2010 (EFSA/GMO/BE/2010/81). The VKM GMO Panel has previously issued a scientific opinion related to the notification C/BE/96/01 for the placing on the market of the oilseed rape lines for import, processing and feed uses (VKM 2008). The health and environmental risk assessment was commissioned by the Norwegian Directorate for Nature Management in connection with the national finalisation of the procedure of the notification C/BE/96/01 in 2008. Due to the publication of updated guidelines for environmental risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated environmental risk assessment of oilseed rape MS8, RF3 and MS8 x RF3. A scientific opinion on an application for the placing on the market of MS8/RF3 for food containing or consisting of, and food produced from or containing ingredients produced from MS8/RF3 (with the exception of processed oil) (EFSA/GMO/BE/2010/81) have also been submitted by the VKM GMO Panel (VKM 2012). The environmental risk assessment of the oilseed rape MS8, RF3 and MS8 x RF3 is based on information provided by the notifier in the applications EFSA/GMO/RX/MS8/RF3, EFSA/GMO/BE/2010/8, the notification C/BE/96/01, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MS8, RF3 and MS8 x RF3 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of oilseed rape MS8, RF3 and MS8 x RF3 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The genetically modified oilseed rape lines MS8 and RF3 were developed to provide a pollination control system for production of F1-hybrid seeds (MS8 x RF3). Oilseed rape is a crop capable of undergoing both self-pollination (70%) as well as cross-pollination (30%). Therefore a system to ensure only cross-pollination is required for producing hybrids from two distinct parents. As a result of hybrid vigor cross-pollinated plants produce higher yield as compared to self-pollinating rape. The hybrid system is achieved using a pollination control system by insertion and expression of barnase and barstar genes derived from the soil bacterium Bacillus amyloliquefaciens into two separate transgenic oilseed rape lines. The barnase gene in the male sterile line MS8 encode a ribonuclease peptide (RNase), expressed in the tapetum cells during anther development. The RNase effect RNA levels, disrupting normal cell function, arresting early anther development, and results in the lack of viable pollen and male sterility. The fertility restoration line RF3 contains a barstar gene, coding for a ribonuclease inhibitor (Barstar peptide) expressed only in the tapetum cells of the pollen during anther development. The peptide specifically inhibits the Barnase RNase expressed by the MS8 line. The RNase and the ribonuclease inhibitor form a stable one-to-one complex, in which the RNase is inactivated. As a result, when pollen from the receptor line RF3 is crossed to the male sterile line MS8, the MS8 x RF3 progeny expresses the RNase inhibitor in the tapetum cells of the anthers allowing hybrid plants to develop normal anthers and restore fertility. The barnase and barstar genes in MS8 and RF3 are each linked with the bar gene from Streptomyces hygroscopus. The bar gene is driven by a plant promoter that is active in all green tissues of the plant, and encodes the enzyme phosphinothricin acetyltransferase (PAT). The PAT enzyme inactivates phosphinothricin (PPT), the active constituent of the non-selective herbicide glufosinate-ammonium. The bar gen were transferred to the oilseed rape plants as markers both for use during in vitro selection and as a breeding selection tool in seed production. Molecular characterization: The oilseed rape hybrid MS8xRF3 is produced by conventional crossing. The parental lines MS8 and RF3 are well described in the documentation provided by the applicant, and a number of publications support their data. It seems likely that MS8 contains a complete copy of the desired T-DNA construct including the bar and barnase genes. Likewise, the event RF3 is likely to contain complete copies of the bar and barstar genes in addition to a second incomplete non-functional copy of the bar-gene. The inserts in the single events are preserved in the hybrid MS8xRF3, and the desired traits are stably inherited over generations. Oilseed rape MS8, RF3 and MS8xRF3 and the physical, chemical and functional characteristics of the newly expressed proteins have previously been evaluated by the VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2008, 2012). The GMO Panel finds the characterisation of the physical, chemical and functional properties of the recombinant inserts in the oilseed rape transformation events MS8, RF3 and MS8xRF3 to be satisfactory. The GMO Panel has not identified any novel risks associated with the modified plants based on the molecular characterisation of the inserts. Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Europe and Canada, it is concluded that oilseed rape MS8, RF3 and MS8 x RF3 is agronomically and phenotypically equivalent to the conventional counterpart, except for the newly expressed barnase, barstar and PAT proteins. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of event MS8, RF3 and MS8 x RF3 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glufosinate herbicide do not alter the phenotypic and agronomic characteristics of event MS8, RF3 and MS8 x RF3 compared to conventional oilseed rape varieties. Environmental risk: Considering the scope of the notification C/BE/96/01, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MS8, RF3 and MS8 x RF3 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30%, but outcrossing frequencies up to 55% are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas t
RESUMO
The environmental risk assessment of the insect resistant genetically modified maize MON 89034 (Reference EFSA/GMO/BE/2011/90) has been performed by the Panel on Genetically Modified Organisms (GMO) of the Norwegian Scientific Committee for Food Safety (VKM). VKM has been requested by the Norwegian Directorate for Nature Management and the Norwegian Food Safety Authority to issue a preliminary scientific opinion on the safety of the genetically modified maize MON 89034 (Unique identifier MON-89Ø34-3) for cultivation, and submit relevant scientific comments or questions to EFSA on the application EFSA/GMOBE/2011/90. The current submission is intended to complement application EFSA-GMO-NL-2007-37, which was approved by Commission Decision 2009/813/EC of 30 October 2009, authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 (scope import, processing, food and feed). Maize MON89034 has previously been assessed by the VKM GMO Panel in connection with EFSA´s public hearing of the application EFSA/GMO/NL/2007/37 (VKM 2008a). Preliminary health- and environmental risk assessments of several stacked events, with MON 89034 as one of the parental lines, have also been performed by the VKM GMO Panel (VKM 2009a, b, c; VKM 2010a,b). The environmental risk assessment of the maize MON 89034 is based on information provided by the applicant in the application EFSA/GMO/BE/2011/90, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON 89034 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of maize MON 89034 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The genetically modified maize MON 89034 was developed to provide protection against certain lepidopteran target pest, including European corn borer (Ostrinia nubilalis) and Mediterranean corn borer (Sesamia nonagrioides). Protection is achieved through expression in the plant of two insecticidal Cry proteins, Cry1A.105 and Cry2Ab2, derived from Bacillus thuringiensis, a common soil bacterium. Cry1A.105, encoded by the cry1A.105 gene, is a chimeric protein made up of different functional domains derived from three wild-type Cry proteins from B. thuringiensis subspecies kurstaki and aizawai. The Cry2Ab2 protein is encoded by the cry2Ab2 gene derived from B. thuringiensis subspecies kurstaki. Molecular characterization: Appropriate analysis of the integration site, including flanking sequence and bioinformatics analysis, has been performed to characterise the transformation event MON 89034. The results of the segregation analysis are consistent with a single site of insertion for the cry1A.105 and cry2Ab2 gene expression cassettes and confirm the results of the molecular characterisation. Molecular analysis of both self-pollinated and cross-fertilised lines, representing a total of seven different generations, indicates that the inserted DNA is stably transformed and inherited from one generation to the next. No genes that encode resistance to antibiotics are present in the genome of MON 89034 maize. The molecular characterisation confirmed the absence of both the aad and nptII genes, which were used in the cloning and transformation process. Event MON 89034 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2008a). Comparative assessment: The field trials for comparative assessment of agronomic and phenotypic characteristics of maize MON 89034 in the USA (2004-2005) and Europe (2007), have been performed in accordance with the EFSAs guidelines for risk assessment of genetically modified plants and derived food and feed (EFSA 2010, 2011a). Based on results from the comparative analyses, it is concluded that maize MON 89034 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of the lepidopteran-protection trait. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON 89034 compared to conventional maize. Evaluations of ecological interactions between maize MON 89034 and the biotic and abiotic environment indicate no unintended effects of the introduced trait on agronomic and phenotypic characteristics. Environmental risk: There are no reports of the target Lepidopteran species attaining pest status on maize in Norway. Since there are no Bt-based insecticides approved for use in Norway, and lepidopteran pests have not been registered in maize, issues related to resistance evolution in target pests are not relevant at present for Norwegian agriculture. Published scientific studies show no or negligible adverse effects of Cry1A.105 and Cry2Ab2 proteins on non-target arthropods that live on or in the vicinity of maize plants. Cultivation of maize MON 89034 is not considered to represent a threat to the prevalence of red-listed species in Norway. Few studies have been published examining potential effects of Cry1A.105 and Cry2Ab toxin on ecosystems in soil, mineralization, nutrient turnover and soil communities. Some field studies have indicated that root exudates and decaying plant material containing Cry proteins may affect population size and activity of rhizosphere organisms (soil protozoa and microorganisms). However, data are only available from short term experiments and predictions of potential long term effects are difficult to deduce. Most studies conclude that effects on soil microorganisms and microbial communities are transient and minor compared to effects caused by agronomic and environmental factors. Few studies have assessed the impact of Cry proteins on non-target aquatic arthropods and the fate of these proteins in senescent and decaying maize detritus in aquatic environments. Further studies with better experimental design are needed for the assessment of the potential effects of Bt crops on aquatic organisms. However, exposure of non-target organisms to Cry proteins in aquatic ecosystems is likely to be very low, and potential exposure of Bt toxins to non-target organisms in stream ecosystems in Norway is considered to be negligible. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation with which maize can hybridise and form backcross progeny. Vertical gene transfer in maize therefore depends on cross-pollination with other conventional or organic maize varieties. In addition, unintended admixture of genetically modified material in seeds represents a possible way for gene flow between different crop cultivations. The risk of pollen flow from maize volunteers is negligible under Norwegian growing conditions. In addition to the data presented by the applicant, the VKM GMO Panel is not aware of any scientific report of increased establishment and spread of maize MON 89034 and any change in survival (including over-wintering), persistence and invasiveness capacity. Because the general characteristics of maize MON 89034 are unchanged, insect resistance are not likely to provide a selective advantage outside cultivation in Norway. Since MON 89034 has no altered agronomic and phenotypic characteristics, except for the specific target pest resistance, the VKM GMO Panel is of the opinion that the likelihood of unintended environmental effects due to the establishment and survival of maize MON 89034 will be no different to that of conventional maize varieties in Norway The environmental risk assessment will be completed and finalized by the VKM Panel on Genetically Modified Organisms when requested additional information from the applicant is available.
RESUMO
The environmental risk assessment of the herbicide tolerant genetically modified oilseed rape MON 88302 (Reference EFSA/GMO/BE/2011/101) has been performed by the Panel on Genetically Modified Organisms (GMO) of the Norwegian Scientific Committee for Food Safety (VKM). VKM has been requested by the Norwegian Directorate for Nature Management and the Norwegian Food Safety Authority to issue a preliminary scientific opinion on the safety of the genetically modified oilseed rape MON 88302 (Unique identifier MON-88Ø2-9) for food and feed uses, import and processing, and submit relevant scientific comments or questions to EFSA on the application EFSA/GMOBE/2011/101. The environmental risk assessment of the MON 88302 is based on information provided by the applicant in the application EFSA/GMO/BE/2011/101, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON 88302 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of oilseed rape MON 88302 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasized that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The GMO Panel has therefore not considered possible health and environmental effects of cultivation and processing of oilseed rape MON 88302 outside the EU/EEA area. The genetically modified oilseed rape MON 88302 was developed to provide tolerance to the herbical active substance glyphosate by the introduction of a gene coding for the enzyme 5enolpyruvylshikimate-3-phosphate synthase (EPSPS) from Agrobacterium tumefaciens, strain CP4 (CP4 EPSPS). Glyphosate is a non-selective herbicide and is normally phytotoxic to a broad range of plants. Its mode of action occurs by binding to and inactivating the EPSPS protein, which is a key enzyme in the shikimate pathway that leads to the biosynthesis of the aromatic amino acids tyrosine, tryptophan and phenylalanine. The disruption of this pathway and the resulting inability to produce key amino acids prevents growth and ultimately leads to plant death. Molecular characterization: The VKM Panel on Genetically Modified Organisms find the conclusion that no major section of the T-DNA plasmid backbone is inserted in MON88302 oilseed rape justified. We also find it justified that there is only one major T-DNA insert in MON88302. Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in the USA, Canada and Chile, it is concluded that oilseed rape MON 88302 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of the herbicide tolerance conferred by the CP4 EPSPS protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON 88302 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glyphosate herbicide do not alter the phenotypic and agronomic characteristics of MON 88302 compared to conventional oilseed rape. Evaluations of environmental interactions between genetically modified oilseed rape MON 88302 and the biotic and abiotic environment, and studies of seed dormancy, seed germination, pollen morphology and viability indicates no unintended effects of the introduced trait on these characteristics in MON 88302 oilseed rape. Environmental risk: Considering the scope of the application EFSA/GMO/BE/2011/101, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MON 88302 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30 %, but outcrossing frequencies up to 55 % are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B.juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MON 88302, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to glyphosate-containing herbicides. However, accidental spillage and loss of viable seeds of MON 88302 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MON 88302 on locations where glyphosate is frequently applied to control weeds e.g. on railway tracks, cannot be excluded. Feral oilseed rape MON 88302 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario. Apart from the glyphosate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. The VKM GMO Panel concludes that this route of gene flow would not introduce significant numbers of transgenic plants into agricultural areas or result in any environmental consequences in Norway. The environmental risk assessment will be completed and finalized by the VKM Panel on Genetically Modified Organisms when requested additional information from the applicant is available.
RESUMO
In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Directorate requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. MON810 notification C/F/95/12-02 is approved under Directive 90/220/EEC for cultivation, seed production, import and processing into feeding stuffs and industrial purposes since 22 April 1998 (Commission Decision 98/294/EC). In December 1997, food and food ingredients derived from the progeny of maize line MON810 were notified under Article 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients. In addition, existing food and feed products containing, consisting of or produced from MON810 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed in the Community Register in 2005. Three applications for renewal of the authorisation for continued marketing of (1) existing food and food ingredients produced from MON810; (2) feed consisting of and/or containing maize MON810, and MON810 for feed use (including cultivation); and (3) food and feed additives, and feed materials produced from maize MON810 within the framework of Regulation (EC) No 1829/2003 were submitted in 2007. Maize MON810 has previously been assessed by the VKM GMO Panel commissioned by the Norwegian Directorate for Nature Management in connection with the national finalisation of the procedure of the notification C/F/95/12/02 (VKM 2007a,b). In addition, MON810 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2005a,b,c, VKM 2007c, VKM 2008, VKM 2009, VKM 2012). Due to the publication of updated guidelines for environmental risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated environmental risk assessment of MON810. The environmental risk assessment of the maize MON810 is based on information provided by the applicant in the notification C/F/95/12/02 and application EFSA/GMO/RX/MON810, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON810 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of maize MON810 include molecular characterisation of the inserted DNA and expression of the target protein, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The genetically modified maize MON810 was developed to provide protection against certain lepidopteran target pests, including European corn borer (Ostrinia nubilalis) and species belonging to the genus Sesamia. Protection is achieved through expression in the plant of the insecticidal Cry protein, Cry1Ab, derived from Bacillus thuringiensis ssp. kurstaki, a common soil bacterium. Molecular characterisation Appropriate analysis of the integration site including flanking sequences and bioinformatics analyses have been performed to analyse the construct integrated in the GM plant. Updated bioinformatics analyses revealed that one ORF shared sequence similarity to a putative HECT-ubiquitin ligase protein. The VKM GMO Panel found no safety implications from the interruption of this gene sequence. Analyses of leaf, grains, whole plant tissue and pollen from the maize MON 810 demonstrated that the Cry1Ab protein is expressed at very low levels in all tissues tested and constitutes less than 0.001% of the fresh weight in each tissue. The cry1Ab gene is the only transgene expressed in line MON 810 and was expressed highest in the leaves. The stability of the genetic modification has been demonstrated over several generations. Event MON810 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2007a,b). Comparative assessment: Comparative analyses of data from field trials located at representative sites and environments in the USA and Europe indicate that maize MON810 is agronomically and phenotypically equivalent to the conventional counterpart and commercially available reference varieties, with the exception of the lepidopteran-protection trait, conferred by the expression of the Cry1Ab protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON810 compared to conventional maize. Evaluations of ecological interactions between maize MON810 and the biotic and abiotic environment indicate no unintended effects of the introduced trait on agronomic and phenotypic characteristics. Environmental risk: There are no reports of the target lepidopteran species attaining pest status on maize in Norway. Since there are no Bt-based insecticides approved for use in Norway, and lepidopteran pests have not been registered in maize, issues related to resistance evolution in target pests are not relevant at present for Norwegian agriculture. Published scientific studies show no or negligible adverse effects of Cry1Ab protein on non-target arthropods that live on or in the vicinity of maize plants. Cultivation of maize MON810 is not considered to represent a threat to the prevalence of red-listed species in Norway. Few studies have been published examining potential effects of Cry1Ab toxin on ecosystems in soil, mineralization, nutrient turnover and soil communities. Some field studies have indicated that root exudates and decaying plant material containing Cry proteins may affect population size and activity of rhizosphere organisms (soil protozoa and microorganisms). Most studies conclude that effects on soil microorganisms and microbial communities are transient and minor compared to effects caused by agronomic and environmental factors. However, data are only available from short term experiments and predictions of potential long term effects are difficult to deduce. Few studies have assessed the impact of Cry proteins on non-target aquatic arthropods and the fate of these proteins in senescent and decaying maize detritus in aquatic environments. However, exposure of non-target organisms to Cry proteins in aquatic ecosystems is likely to be very low, and potential exposure of Bt toxins to non-target organisms in aquatic ecosystems in Norway is considered to be negligible. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation with which maize can hybridise and form backcross progeny. Vertical gene transfer in maize therefore depends on cross-pollination with other conventional or organic maize varieties. In addition, unintended admixture of genetically modified material in seeds represents a possible way for gene flow between different crop cultivations. The risk of pollen flow from maize volunteers is negligible under Norwegian growing conditions. In addition to the data presented by the applicant, the VKM GMO Panel is not aware of any scientific report of increased establishment and spread of maize MON810 and any change in survival (including over-wintering), persistence and invasiveness capacity. Because the general characteristics of maize MON810 are unchanged, insect resistance are not likely to provide a selective advantage outside cultivation in Norway. Since MON810 has no altered agronomic and phenotypic characteristics, except for the specific target pest resistance, the VKM GMO Panel is of the opinion that the likelihood of unintended environmental effects due to the establishment and survival of maize MON810 will be no different to that of conventional maize varieties in Norway. Overall conclusion: The VKM GMO Panel concludes that cultivation of maize MON810 is unlikely to have any adverse effect on the environment in Norway.
RESUMO
In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The assignment includes a scientific environmental risk assessment of oilseed rape T45 (Reference EFSA/GMO/UK/2005/25) from Bayer CropScience for food and feed uses, import and processing. Oilseed rape T45 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority related to the EFSAs public hearing in 2007 (VKM 2007a). Food additives produced from T45 oilseed rape were notified in the EU as existing food additives within the meaning of Article 8 (1)(b) of Regulation 1829/2003, authorized under Directive 89/10/EEC (Community Register 2005). Feed materials produced from T45 were also notified as existing feed products containing, consisting of or produced from T45 according to Articles 8 and 20 of Regulation (EC) No 1829/2003 in 2003. A notification for placing on the market of T45 according to the Directive 2001/18/EC was submitted in March 2004 (C/GB/04/M5/4), covering import and processing of T45 into food and feed. The application was further transferred into Regulation (EC) No 1829/2003 in November 2005 (EFSA/GMO/UK/2005/25). An application for renewal of authorisation for continued marketing of food additives and feed materials produced from T45 oilseed rape was submitted under Regulation (EC) No 1829/2003 in 2007 (EFSA/GMO/RX/T45). The EFSA GMO Panel performed one single comprehensive risk assessment for all intended uses of genetically modified oilseed rape T45, and issued a comprehensive scientific opinion for both applications submitted under Regulation (EC) No 1829/2003. The scientific opinion was published in January 30 2008 (EFSA 2008), and food and feed products containing or produced from oilseed rape T45 was approved by Commission Decision 26 March 2009 (Commission Decision 2009/184/EC). The oilseed rape T45 is however currently being phased out (EU-COM 2009). The commercialisation of T45 oilseed rape seeds in third countries was stopped after the 2005 planting season and stocks of all oilseed rape T45 lines have been recalled from distribution and destroyed. The applicant commits not to commercialize the event in the future and the import will therefore be restricted to adventitious levels in oilseed rape commodity. Thus the incidence of oilseed rape T45 in the EU is expected to be limited. The environmental risk assessment of the oilseed rape T45 is based on information provided by the notifier in the application EFSA/GMO/UK/2005/25 and EFSA/GMO/RX/T45, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated T45 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of oilseed rape T45 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The glufosinate ammonium-tolerant oilseed rape transformation event T45 (Unique Identfier ACSBNØØ8-2) was developed by Agrobacterium-mediated transformation of protoplast from the conventional oilseed rape cultivar “AC Excel”. T45 contains a synthetic version of the native pat gene isolated from the bacteria Streptomyces viridochromogenes, strain Tü 494. The inserted gene encodes the enzyme phosphinothricin acetyltransferase (PAT), which confers tolerance to the herbical active substance glufosinate ammonium. The PAT enzyme detoxifies glufosinate-ammonium by acetylation of the L-isomer into N-acetyl-L-glufosinate ammonium (NAG) which does not inhibit glutamine synthetase and therefore confers tolerance to the herbicide. Glufosinate ammonium-tolerant oilseed rape transformation event T45 has been conventionally bred into an array of spring-type oilseed rape varieties. Molecular characterization: The molecular characterisation data established that only one copy of the gene cassette is integrated in the oilseed rape genomic DNA. Appropriate analysis of the integration site including sequence determination of the inserted DNA and flanking regions and bioinformatics analysis have been performed. Bioinformatics analyses of junction regions demonstrated the absence of any potential new ORFs coding for known toxins or allergens. The genetic stability of transformation event T45 was demonstrated at the genomic level over multiple generations by Southern analysis. Segregation analysis shows that event T45 is inherited as dominant, single locus trait. Phenotypic stability has been confirmed by stable tolerance to the herbicide for T45 lines and varieties derived from the event grown in Canada since 1993. Oilseed rape transformation event T45 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2007a). Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Canada in 1995-1997, it is concluded that oilseed rape T45 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of maturity and the herbicide tolerance conferred by the PAT protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of event T45 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glufosinate herbicide do not alter the phenotypic and agronomic characteristics of event T45 compared to conventional oilseed rape. Environmental risk: According to the applicant, the event T45 has been phased out, and stocks of all oilseed rape T45 lines have been recalled from distribution and destroyed since 2005. However, since future cultivation and import of oilseed rape T45 into the EU/EEA area cannot be entirely ruled out, the environmental risk assessment consider exposure of viable seeds of T45 through accidental spillage into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30%, but outcrossing frequencies up to 55% are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B. juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape T45, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Accidental spillage and loss of viable seeds of T45 during transport, storage, handling in the environment and processing into derived products is, however, likely to take place over time, and the establishment of small populations of oilseed rape T45 cannot be excluded. Feral oilseed rape T45 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adja
RESUMO
In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The insect-resistant and glyphosate-tolerant genetically modified maize MON 89034 x NK 603 from Monsanto (Unique Identifier MON-89Ø34-3 × MON-ØØ6Ø3-6) was approved under Regulation (EC) No 1829/2003 in the EU for food and feed uses, import and processing on 28 July 2010 (Commission Decision 2010/420/EC). Genetically modified maize MON 890314 x NK 603 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority and the Norwegian Environment Agency related and to the EFSA public hearing of the applications EFSA/GMO/NL/2007/38 and EFSA/GMO/NL/2009/72 in 2007 and 2009/2010 (VKM 2008a, VKM 2010a). In addition, the parental lines MON 89034 and NK 603 have been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2005a,b,c,d,e, VKM 2007a,b, VKM 2008b,c,d, VKM 2009a,b, VKM 2010 a,b, VKM 2011, VKM 2012a,b, VKM 2013 a,b, VKM 2014). The food/feed and environmental risk assessment of the maize MON 89034 x NK 603 is based on information provided by the applicant in the applications EFSA/GMO/NL/2007/38 EFSA/GMO/NL/2009/72 and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON 89034 x NK 603 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010a), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c). The scientific risk assessment of maize MON 89034 x NK 603 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, effects on biogeochemical processes and interactions between the GM plant and target and non-target organisms. It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. Likewise, the VKM mandate does not include evaluations of herbicide residues in food and feed from genetically modified plants. The hybrid maize MON 89034 x NK 603 has been produced by conventional crosses between inbred lines containing MON 89034 and NK 603 events to combine resistance to certain lepidopteran pests and to confer tolerance towards glyphosate-containing herbicides. Maize MON 89034 was developed to provide protection against specific lepidopteran target pest, including Ostrinia nubilalis, S podoptera spp. and Agrotis ipsilon. Protection is achieved through expression in the plant of two insecticidal Cry proteins, Cry1A.105 and Cry2Ab2, derived from Baci llus thuringiensis subsp. a izawai and kurstaki. Maize NK 603 has been developed to provide tolerance to glyphosate by the introduction, of a gene coding for 5enolpyruvylshikimate-3-phosphate synthase (EPSPS) from Agrobacterium sp. strain CP4 (CP4 EPSPS). Molecular Characterisation: Southern and PCR analyses indicate that the recombinant inserts in the single maize events MON 89034 and NK 603 are retained in maize stack MON 89034 x NK603. Genetic stability of the inserts has previously been demonstrated in the parental lines MON 89034and NK603. The level of Cry1A.105, Cry2Ab2 and CP4 EPSPS proteins in grain and forage from the stacked event are comparable to the levels in the corresponding single events. Phenotypic analyses also indicate stability of the insect resistance and herbicide tolerance traits of the stacked event. Based on current knowledge and the previous assessments of the parental maize events, the VKM GMO Panel considers the molecular characterisation of maize MON 89034 x NK 603 satisfactory. 6 VKM Report 2016: 17. Comparative Assessment: The applicant has performed comparative analyses of data from field trials located at representative sites and environments in Argentina in 2004/2005 and Europe in 2007. With the exception of small intermittent variations and the insect resistance and herbicide tolerance conferred by the Cry1A.105, Cry2Ab2 and CP4 EPSPS proteins, the results showed no biologically relevant differences between maize stack MON 89034 x NK 603 and conventional control. Based on the assessment of available data, the VKM GMO Panel concludes that maize MON 89034 x NK 603 is compositionally, agronomical and phenotypically equivalent to its conventional counterpart, except for the new proteins. Food/feed Safety Assessment: A whole food feeding study on broilers has not indicated any adverse health effects of maize MON 89034 x NK 603, and shows that it is nutritionally equivalent to conventional maize varieties. The Cry1A.105, Cry2Ab2, and CP4 EPSPS proteins do not show sequence resemblance to other known toxins or IgE allergens, nor have they been reported to cause IgE mediated allergic reactions. However, some studies have indicated a potential role of Cry-proteins as adjuvants in allergic reactions. Based on current knowledge, the VKM GMO Panel concludes that maize MON 89034 x NK 603 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1A.105, Cry2Ab2, and CP4 EPSPS proteins will cause toxic or IgE-mediated allergic reactions to food or feed based on maize MON 89034 x NK 603 compared to conventional maize. Environmental Risk: Considering the intended uses of maize MON 89034 x NK603, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize MON 89034 x NK603. Maize MON 89034 x NK 603 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize MON 89034 x NK603. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue. 7 VKM Report 2016: 17. Overall Conclusion: Based on current knowledge, the VKM GMO Panel concludes that maize MON 89034 x NK 603 is compositionally, nutritionally, agronomically and phenotypically equivalent to its conventional counterpart except for the new proteins. It is unlikely that the Cry1A.105, Cry2Ab2 and CP4 EPSPS proteins will cause an increased risk of toxic or IgE-mediated allergic reactions to food or feed based on maize MON 89034 x NK 603 compared to conventional maize varieties. The VKM GMO Panel concludes that maize MON 89034 x NK603, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.
RESUMO
In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The insect-resistant and glyphosate-tolerant genetically modified maize MON 89034 x MON 88017 from Monsanto (Unique Identifier MON-89Ø34-3 × MON-88Ø17-3) was approved under Regulation (EC) No 1829/2003 in the EU for food and feed uses, import and processing on 17th of June 2011 (Commission Decision 2011/366/EC). Genetically modified maize MON 890314 x MON 88017 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority and the Norwegian Environment Agency related and to the EFSA public hearing of the applications EFSA/GMO/NL/2007/39 and EFSA/GMO/BE/2009/71 in 2007 and 2009/2010 (VKM 2008a, VKM 2010a). In addition, the parental lines MON 89034 and MON 88017 have been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2007a,b, VKM 2008b, VKM 2009a,b,c, VKM 2010b,c, VKM 2012, VKM 2013, VKM 2014). The food/feed and environmental risk assessment of the maize MON 89034 x MON 88017 is based on information provided by the applicant in the applications EFSA/GMO/NL/2007/39 EFSA/GMO/BE/2009/71 and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature when relevant. The VKM GMO Panel has evaluated MON 89034 x MON 88017 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c). The scientific risk assessment of maize MON 89034 x MON 88017 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, effects on biogeochemical processes and interactions between the GM plant and target and non-target organisms. It is emphasised that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. Likewise, the VKM mandate does not include evaluations of herbicide residues in food and feed from genetically modified plants.The hybrid maize MON 89034 x MON 88017 has been produced by conventional crosses between inbred lines containing MON 89034 and MON 88017 events to combine resistance to certain coleopteran and lepidopteran pests, and to confer tolerance towards glyphosate-containing herbicides. Maize MON 89034 was developed to provide protection against specific lepidopteran target pest, including Ostrinia nubilalis , S podoptera spp. and Agrotis ipsilon. Protection is achieved through expression in the plant of two insecticidal Cry proteins, Cry1A.105 and Cry2Ab2, derived from Bacillus thuringiensis subsp. a izawai and kurstaki. Maize MON 88017 was developed to express a modified Cry3Bb1 insecticidal protein, derived from B. thuringiensis subsp. kumamotoensis , which confers protection against coleopteran target pests belonging to the genus Diabrotica such as Western corn rootworm ( D . virgifera virgifera ). MON 88017 is also developed to provide tolerance to the herbicidal active substance glyphosate by the introduction of a gene coding for the enzyme 5enolpyruvylshikimate-3-phosphate synthase (EPSPS), from Agrobacterium tumefaciens strain CP4 (CP4 EPSPS). Molecular Characterisation: Southern and PCR analyses indicate that the recombinant inserts in the single maize events MON 89034 and MON 88017 are retained in the stacked event MON 89034 x MON 88017. Genetic stability of the inserts has previously been demonstrated in the single events. The levels of Cry1A.105, Cry2Ab2, CP4 EPSPS and Cry3Bb1 proteins in grain and forage from the stacked event are comparable to the levels in the corresponding single events. Phenotypic analyses also indicate stability of the insect resistance and herbicide tolerance traits of the stacked event. Based on current knowledge and the previous assessments of the parental maize events, the VKM GMO Panel considers the molecular characterisation of maize MON 89034 x MON 88017 satisfactory. Comparative Assessment: Comparative analyses of maize MON 89034 x MON 88017 and its conventional counterpart have been performed by the applicant during field trials located at representative sites and environments in USA during 2004, and in Europe in 2007. Several different conventional maize varieties were included in the field trials and used as references. With the exception of small variations, and the insect resistance and herbicide tolerance conferred by the Cry3Bb1, Cry1A105, Cry2Ab2, and CP4 EPSPS proteins, the results from these studies showed no biologically relevant differences between the maize stack MON 89034 x MON 88017 and its conventional counterpart. Based on the assessment of available data, the VKM GMO Panel concludes that maize MON 89034 x MON 88017 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the new proteins. Food and Feed Safety Assessment: A whole food feeding study performed on broilers indicates no adverse health effects of maize MON 89034 x MON 88017, and shows that it is nutritionally equivalent to conventional maize varieties. The Cry1A.105, Cry2Ab2, Cry3Bb1 and CP4 EPSPS proteins do not show relevant sequence resemblance to other known toxins or IgE-allergens, nor have they been reported to cause IgE-mediated allergic reactions. However, some studies have indicated a potential role of Cry-proteins as adjuvants in allergic reactions. Based on current knowledge, the VKM GMO Panel concludes that maize MON 89034 x MON 88017 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1A.105, Cry2Ab2, Cry3Bb1 and CP4 EPSPS proteins will cause toxic or IgE-mediated allergic reactions to food or feed derived from maize MON 89034 x MON 88017 compared to conventional maize. Environmental Risk: Considering the intended uses of maize MON 89034 x MON 88017, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize MON 89034 x MON 88017. Maize MON 89034 x MON 88017 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize MON 89034 x MON 88017. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue. Overall Conclusion: Based on current knowledge, the VKM GMO Panel concludes that maize MON 89034 x MON 88017 is compositionally, nutritionally, agronomically and phenotypically equivalent to its conventional counterpart except for the new proteins. It is unlikely that the Cry1A.105, Cry2Ab2, CryBb1 and CP4 EPSPS proteins will cause an increased risk of toxic or IgE-mediated allergic reactions to food or feed based on maize MON 89034 x MON 88017 compared to conventional maize varieties. The VKM GMO Panel concludes that maize MON 89034 x MON 88017, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.
RESUMO
In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The insect-resistant and glyphosate-tolerant genetically modified maize MON 88017 x MON 810 from Monsanto (Unique Identifier DAS-MON 88017-3 x MON-ØØ81Ø-6) was approved under Regulation (EC) No 1829/2003 in the EU for food and feed uses, import and processing on 28th of July 2010 (Commission Decision 2010/429/EC). Genetically modified maize MON 88017 x MON 810 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority related to the EFSA public hearing of the application in 2007 (VKM 2007a). In addition, MON 88017 and MON 810 has been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events and Regulation (EC) 1829/2003 and Directive 2001/18/EC (VKM 2005a,b,c, VKM 2007b,c,d, VKM 2008, VKM 2009, VKM 2010 a,b,c, VKM 2012, VKM 2013, VKM 2016). The food/feed and environmental risk assessment of the maize MON 88017 x MON 810 is based on information provided by the applicant in the application EFSA/GMO/CZ/2006/33 and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON 88017 x MON 810 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c). The scientific risk assessment of maize MON 88017 x MON 810 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, effects on biogeochemical processes and interactions between the GM plant and target and non-target organisms. It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. Likewise, the VKM mandate does not include evaluations of herbicide residues in food and feed from genetically modified plants. The hybrid maize MON 88017 x MON 810 was produced by conventional crosses between inbred lines containing MON 88017 and MON 810 events to combine resistance to certain coleopteran and lepidopteran pests, and to confer tolerance towards glyphosate-containing herbicides. Maize MON 88017 was developed to express a modified Cry3Bb1 insecticidal protein, derived from Bacillus thuringiensis subsp. kumamotoensis , which confers protection against coleopteran target pests belonging to the genus Diabrotica such as Western corn rootworm ( Diabrotica virgifera virgifera ). MON 88017 is also developed to provide tolerance to the herbicidal active substance glyphosate by the introduction of a gene coding for the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), from Agrobacteri um tumefaciens strain CP4 (CP4 EPSPS). Maize MON 810 expresses the Cry1Ab insecticidal protein, derived from Bacillus thuringiensis subsp. k u rstaki, which confers protection against lepidopteran pests such as Ostrinia nubilaris and species belonging to the genus Sesamia. Molecular characterisation Southern and PCR analyses indicate that the recombinant inserts in the single maize events MON 88017 and MON 810 are retained in the stacked event MON 88017 x MON 810. Genetic stability of the inserts has previously been demonstrated in the single events. The levels of CP4 EPSPS, Cry3Bb1 and Cry1Ab proteins in grain and forage from the stacked event are comparable to the levels in the corresponding single events. Phenotypic analyses also indicate stability of the insect resistance and herbicide tolerance traits of the stacked event. Based on current knowledge and the previous assessments of the parental maize events, the VKM GMO Panel considers the molecular characterisation of maize MON 88017 x MON 810 satisfactory. Comparative assessment The applicant has performed comparative analyses of data from field trials located at representative sites and environments in USA during the 2002 growing season. With the exception of small intermittent variations and the insect resistance and herbicide tolerance conferred by the CP4 EPSPS, Cry3Bb1 and Cry1Ab proteins, the results showed no biologically relevant differences between maize stack MON 88017 x MON 810 and its conventional counterpart. Based on the assessment of available data, the VKM GMO Panel concludes that maize MON 88017 x MON 810 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the new proteins. Food and feed safety assessment A whole food feeding study on broilers indicates no adverse health effects of maize MON 88017 x MON 810, and shows that it is nutritionally equivalent to conventional maize varieties. The Cry3Bb1, Cry1Ab and CP4 EPSPS proteins do not show relevant sequence resemblance to other known toxins or IgE-allergens, nor have they been reported to cause IgE-mediated allergic reactions. However, some studies have indicated a potential role of Cry-proteins as adjuvants in allergic reactions. Based on current knowledge, the VKM GMO Panel concludes that maize MON 88017 x MON 810 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry3Bb1, Cry1Ab and CP4 EPSPS proteins will cause toxic or IgE-mediated allergic reactions to food or feed based on maize MON 88017 x MON 810 compared to conventional maize. Environmental risk assessment Considering the intended uses of maize MON 88017 x MON 810, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize MON 88017 x MON 810. Maize MON 88017 x MON 810 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize MON 88017 x MON 810. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue. Overall conclusion Based on current knowledge, the VKM GMO Panel concludes that maize MON 88017 x MON 810 is compositionally, nutritionally, agronomically and phenotypically equivalent to its conventional counterpart except for the new proteins. It is unlikely that the Cry3Bb1, Cry1Ab and CP4 EPSPS proteins will cause an increased risk of toxic or IgE-mediated allergic reactions to food or feed based on maize MON 88017 x MON 810 compared to conventional maize varieties. The VKM GMO Panel concludes that maize MON 88017 x MON 810, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.
RESUMO
In preparation for a legal implementation of regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The insect-resistant and glyphosate-tolerant genetically modified maize MON 88017 from Monsanto (Unique Identifier DAS-MON 88017-7) was approved in the EU under Regulation (EC) No 1829/2003 for food and feed uses, import and processing the 30th of October 2009 (Commission Decision 2009/814/EC). Genetically modified maize MON 88017 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority and the Norwegian Environment Agency related and to the EFSA public hearing of the applications EFSA/GMO/CZ/2005/27 and EFSA/GMO/CZ/2008/54 in 2007 and 2010 (VKM 2007a, 2010a). In addition, MON 88017 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events and Regulation (EC) 1829/2003 (VKM 2007b, VKM 2008, VKM 2009, VKM 2010b). The food/feed and environmental risk assessment of the maize MON 88017 is based on information provided by the applicant in the applications EFSA/GMO/UK/2005/27 and EFSA/CZ/2008/CZ/2008/54, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON 88017 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010a), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c). 8.04.2016 The scientific risk assessment of maize MON 88017 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes. It is emphasised that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. Genetically modified maize MON 88017 expresses a Cry3Bb1 insecticidal protein, derived from Bacillus thuringiensis subsp. kumamotoensis, which confers protection against coleopteran target pests belonging to the genus Diabrotica such as Western corn rootworm (Diabrotica virgifera virgifera). MON 88017 is also developed to provide tolerance to the herbicidal active substance glyphosate by the introduction of a gene coding for the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), from Agrobacterium tumefaciens strain CP4 (CP4 EPSPS). Molecular characterisation The molecular characterisation data has established that only one copy of the transgene is integrated in the maize genomic DNA. Appropriate analyses of the integration site including sequence determination of the inserted DNA and flanking regions and bioinformatics analysis have been performed. Bioinformatics analyses of junction regions have demonstrated the absence of any potential new ORFs coding for known toxins or allergens. The genetic stability of transformation event MON 88017 was demonstrated at the genomic level over multiple generations by Southern analysis. Segregation analysis shows that event MON 88017 is inherited as a dominant, single locus trait. The VKM GMO Panel considers the molecular characterisation of maize MON 88017 satisfactory. Comparative assessment Comparative analyses of maize MON 88017 and its conventional counterpart have been performed during field trials located at representative sites and environments in Europe and USA. A total of 12-16 different conventional maize varieties were included in the field trials and used as references. With the exception the insect resistance and herbicide tolerance conferred by the Cry3Bb1 and CP4 EPSPS proteins, no biologically relevant differences were found between maize MON 88017 and controls. Based on the assessment of available data, the VKM GMO Panel concludes that maize MON 88017 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart except for the new proteins. 8.04.2016 VKM Report 2016:12 Food and feed safety assessment Whole food feeding studies on rats and broilers indicate no adverse health effects of maize MON 88017. These studies also show that maize MON 88017 is nutritionally equivalent to conventional maize. The Cry3Bb1 and CP4 EPSPS proteins do not show relevant sequence resemblance to other known toxins or IgE-allergens, nor have they been reported to cause IgE-mediated allergic reactions. However, some studies have indicated a potential role of Cry-proteins as adjuvants in allergic reactions. Based on current knowledge, the VKM GMO Panel concludes that maize MON 88017 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry3Bb1 and CP4 EPSPS proteins will cause toxic or IgE-mediated allergic reactions to food or feed based on maize MON 88017 compared to conventional maize. Environmental risk assessment Considering the intended uses of maize MON 88017, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize MON 88017. Maize MON 88017 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize MON 88017. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue. 8.04.2016. VKM Report 2016:12 Overall conclusion Based on current knowledge, the VKM GMO Panel concludes that maize MON 88017 is compositionally, nutritionally, agronomically and phenotypically equivalent to its conventional counterpart except for the new proteins. It is unlikely that the Cry3Bb1 and CP4 EPSPS proteins will cause an increased risk of toxic or IgE-mediated allergic reactions to food or feed based on maize MON 88017 compared to conventional maize. The VKM GMO Panel concludes that maize MON 88017, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.
RESUMO
Genetically modified LLcotton25 from Bayer Crop Science expresses the bar gene from Streptomyces hygroscopicus ATCC21705 encoding the phosphinothricin-acetyl–transferase (PAT) enzyme, which confers tolerance to the active herbicide glufosinate-ammonium. Updated bioinformatics analyses of the inserted DNA and flanking sequences in LLCotton25 have not indicated potential production of putatively harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the bar gene have been shown over several generations of LLCotton25. Data from field trials indicate that with the exception of the newly introduced trait, LLCotton25 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart Coker 312 and other cotton cultivars. A 33-day nutritional assessment trial with broilers has not revealed adverse effects of cottonseed meal from LLCotton25. Toxicity testing of the PAT protein in a repeated-dose dietary exposure test with rats did not indicate adverse effects. The PAT protein produced in LLCotton25 does not show amino acid sequence resemblance to known toxins or IgEdependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the PAT protein will cause toxic or IgE-mediated allergic reactions to food or feed containing LLCotton25 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced traits, the VKM GMO Panel concludes that LLCotton25 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterpart and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that LLCotton25 does not represent an environmental risk in Norway.
RESUMO
Genetically modified cotton GHB614 from Bayer Crop Science expresses a modified epsps gene (2mepsps) gene from maize encoding the enzyme 5-enolpyruvylshikimate 3-phosphate synthase (2 mEPSPS), which confers tolerance to the herbicide glyphosate. Updated bioinformatics analyses of the inserted DNA and flanking sequences in GHB614 have not indicated potential production of putatively harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the 2mepsps gene has been shown over several generations of cotton GHB614. Field trials indicate that with the exception of the introduced trait, cotton GHB614 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart Coker 312 and other cotton cultivars. A 42-day nutritional assessment trial with broilers did not reveal adverse effects of cottonseed meal from GHB614. The 2mEPSPS protein produced in GHB614 does not show amino acid sequence resemblance to known toxins or IgE-dependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the 2 mEPSPS protein will cause toxic or IgE-mediated allergic reactions to food or feed containing cotton GHB614 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced trait, the VKM GMO Panel concludes that cotton GHB614 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterpart and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that GHB614 does not represent an environmental risk in Norway.
RESUMO
The present benefit and risk assessment of breastmilk and contaminants in breastmilk was initiated by the Norwegian Scientific Committee for Food Safety (VKM). The overall objective is to provide a balanced assessment of the benefits of breastmilk against the possible risks from exposure to contaminants in breastmilk with focus on Norwegian conditions. The aim is to contribute to a foundation for decision-makers when providing recommendations on the length of exclusive and partial breastfeeding. The composition of breastmilk is tailored for the needs of the newborn. Provided that the nutritional needs of the mother are met during pregnancy and breastfeeding, breastmilk covers all the nutritional requirements of the infant the first months of life, with the exception of vitamin D. Breastmilk also contains a number of specialised components, including growth factors, factors with anti-microbial and anti-inflammatory properties and selected immunological components which boost the maturation of the infant’s immune system. Infant formula fulfils the infant’s established nutritional needs, but does not provide the specific protective factors which are present only in breastmilk. However, studies over the last four decades have shown that polluting chemicals have accumulated in the environment, biomagnified in the food chain, are in our bodies, and consequently in breastmilk. The levels of lipid-soluble persistent contaminants in the foetus, the newborn child and in breastmilk largely reflect the amount of these in the mother’s body. Thus, breastmilk contains nutrients and protective immunological factors which have a positive effect on infant health, but may also contain contaminants. Particularly lipid-soluble and persistent contaminants accumulate in the infant during breastfeeding. This has contributed to a debate among experts agreeing that breastfeeding is beneficial, but discussing the advisable length of breastfeeding. Breastfeeding in Norway Breastfeeding prevalence is higher in Norway than in most European countries. 80% of the infants are breastfed at 6 months of age and 46% at 12 months. Mean breastfeeding duration is about 10 months. Norwegian health authorities recommend that infants are exclusively breastfed for 6 months with a total duration of at least 12 months. However, only a minority of Norwegian mothers breastfeed exclusively for the recommended 6 months. The prevalence of exclusive breastfeeding declines rapidly from 3 months onwards with only 9% being exclusively breastfed at 6 months. Mean breastmilk consumption in exclusively breastfed infants increases from approximately 700 ml/day at age 1 month to 850 ml/day at age 6 months. The amount of breastmilk provided to the child is not very different between the partially and exclusively breastfed infants during the first 4 months. From 7 months, breastmilk consumption in partially breastfed infants may be about 500 ml/day. There are a few conditions where breastfeeding is contraindicated. Among these are some metabolic disorders, infections and use of certain pharmaceuticals. Nutrients and Immunological Components in Breastmilk The positive health effects of breastmilk relates to nutritious as well as immunological properties. An infant who is exclusively breastfed for the first 6 months of life has, provided adequate nutrition of the mother, all the nutritional needs covered with the exception of vitamin D. Therefore, worldwide, the recommended daily intake of nutrients for infants is derived from the nutrient concentrations in breastmilk multiplied with the average intake of breastmilk. The composition of nutrients in breastmilk varies by stage of lactation, the time of day and during a given feeding. The concentration of some nutrients also varies according to the mother’s diet. The energy content of breastmilk varies, but has been estimated to be about 700 kcal/L. The content of proteins and carbohydrates is relatively stable, while the fat content has large variations. The fatty acid composition and concentrations of most vitamins reflect the maternal intake, while the concentrations of most minerals are not affected by the maternal diet, except for selenium and iodine. Breastmilk has protective properties. It contains a number of specialised components, including factors with anti-microbial and anti-inflammatory properties as well as constituents boosting the maturation of the infant’s immune system. This benefits health in childhood and most likely also later in life. The milk antibodies are targeted against potential pathogens and other antigens to which the mother has been exposed. Moreover, maturation of the infant’s immune system is influenced by contact with the immune-modulating factors in breastmilk as well as dietary and microbial constituents in the infant’s gut. Different components in breastmilk facilitate the establishment of a beneficial intestinal microbiota, which is important for induction of a balanced mucosal immune system. Through all these mechanisms, breastfeeding represents an ingenious immunologic integration of mother and child. Nutrients in Infant Formula If breastfeeding is not possible or if there is a need for more milk in addition to breastmilk, infant formula is recommended until the child is 12 months of age. Infant formula fulfills the infant´s established nutritional needs, but does not provide maternal antibodies and innate defence factors or immunity-promoting components. The majority of the infant formulas on the Norwegian market are cow’s milk-based. Data from a national dietary survey among infants (Spedkost, 2006) showed that at 6 months of age, 43% of the infants in Norway had been introduced to infant formula, and 36% used it regularly. At 1 year of age, 43% of the infants received infant formula regularly. Infant formulas in Norway are subject to EU regulations that cover the composition, labelling, marketing and distribution of the product. The regulations give minimum and maximum limits for nutrients for infant formulas and include some of the provisions of the WHO Code1. Contaminants and Microbiological Organisms in Breastmilk and Infant Formula Breastmilk, as a reflection of the mother’s body, contains low concentrations of a mixture of different contaminants. Only the most prevalent contaminants in breastmilk have been determined chemically and even fewer have been studied in humans with regard to impact on early life health. The main focus of the present benefit and risk assessment of breastmilk are contaminants which are included in the Stockholm convention on Persistent Organic Pollutants (POPs)2. They can be divided into the three main groups; pesticides (DDT and HCB), other halogenated organic pollutants (dioxins and dioxin-like PCBs, non-dioxin-like PCBs, brominated flame retardants (PBDE), perfluorinated compounds (PFOS/PFOA)) and heavy metals (lead, mercury and cadmium). In the identification and characterisation of negative health effects, combined exposures to multiple contaminants3 from breastmilk have to some extent been taken into consideration, as several of the cohorts have been investigating the impact on health outcomes of PCBs and dioxins in combination with DDT or HCB and some in combination with mercury. Additionally, it should be noted that the contaminants studied may be considered as markers for the combined exposure of multiple contaminants, since their occurrences are often correlated. Metal concentrations in both breastmilk and infant formula (e.g. mercury and lead) are generally low and not at levels associated with concern. Due to national and international restrictions and bans on use, the levels of dioxins, PCBs, and pesticides (like DDTs and HCB) have declined substantially (more than 60%) in the environment and in humans the last three decades. Compared to DDTs, HCB, dioxins and PCBs, the concentration of PBDEs in breastmilk in Norway increased until approximately year 2000, after which a decline has been observed. The fluorinated surfactants PFOS and PFOA have shown a similar time trend as the PBDEs. There are limited Norwegian data on levels of persistent organic pollutants in infant formula, but the levels reported are generally much lower than in breastmilk. Some contaminants which do not accumulate in the food chain may also be relevant in both breastmilk and infant formula. Substances from food packaging materials, e.g. phthalates, may be present in both breastmilk and infant formula, as well as process-generated substances such as acrylamide, PAHs, furan and 3-MDCP. The hormone active substance bisphenol A (BPA) used in plastic has recently been banned in infant feeding bottles in EU and Norway. Occurrence data in breastmilk and infant formula for these substances in Norway are scarce. The main difference between the contaminants in breastmilk and those provided by infant formula or bottle-feeding is that breastmilk generally contains higher levels of persistent organic pollutants, while most of the unwanted substances imposed by infant formula and bottle-feeding have a shorter half-life. Infant formula may contain microbial contamination of concern, which may lead to diarrhea and in severe cases bacteraemia and meningitis. Cronobacter spp. (formerly Enterobacter sakazakii) is a rare cause of invasive infection with high death rates in newborn infants. Possible outbreak from microbiological hazards in infant formula itself or due to contaminated water is an issue in developing countries, but no such outbreaks have been registered in Norway. Methodological Approach to this Benefits and Risk Assessment The benefit assessment is based on positive health effects reported in systematic reviews and meta-analyses published within the last 10 years. This implies that VKM has not conducted its own specific literature search to reveal the epidemiological studies that have examined positive health effects of breastmilk, but summarises and discu