Final health and environmental risk assessment of genetically modified soybean 356043

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on 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 within the Authority’s sectoral responsibility

Impact on health when sugar is replaced with intense sweeteners in soft drinks, 'saft' and nectar

The Norwegian Food Safety Authority requested the Norwegian Scientific Committee for Food Safety (VKM) to assess the relationship between consumption of sugared soft drinks, ‘saft’ and nectar and health challenges such as overweight, diabetes and dental health on one hand, and the potential public health risks of elevated intake of intense sweeteners and benzoic acid on the other. The level of benzoic acid might potentially be higher in soft drinks, ‘saft’ and nectar with intense sweeteners since sugar, which has a preservative effect, is removed. VKM was requested to evaluate exposure levels (current situation) from existing national dietary surveys and scenarios where it was assumed that 50% of the consumed soft drinks, ‘saft’ and nectar contain added sugar, and 50% contain intense sweeteners (the 50% scenario) and finally exposure levels where it was assumed that all of the consumed soft drinks, ‘saft’, and nectar contain intense sweeteners (the 100% scenario). This report does not discuss other health problems beside overweight, diabetes and dental health which may be related to high consumption of sugared soft drinks, ‘saft’ and nectar, such as poor nutrient quality of the diet in relationship to coronary heart diseases and cancer

Risk assessment on the use of triclosan in cosmetics; development of antimicrobial resistance in bacteria

The Scientific Committee on Consumer Products (SCCP) of European Commission concluded in its Draft Opinion on triclosan (SCCP/1040/06) of October 10th 2006 that: • On the basis of the available data, the SCCP is of the opinion that there is presently no evidence of clinical resistance and cross-resistance occurring from the use of triclosan in cosmetic products. • Although probable, this link has not been fully demonstrated. Since this conclusion differs from that made by The Norwegian Scientific Committee for Food Safety in its report of January 31st 2005, The Norwegian Food Safety Authority asked The Norwegian Scientific Committee for Food Safety, Panel on Biological Hazards to reconsider their conclusion in view of the SCCP draft opinion and recently published scientific literature

Risk assessment of Macrolophus pygmaeus as biological control product

Macrolophus pygmaeus on the other hand, is already established in Norway. VKM considers that dispersal/migration of M. pygmaeus into the surrounding environment when used for biological control in greenhouses, tunnels and open fields is very likely, and that such escapes (animals) are likely to become established in the environment. However, since the species is already present in Norway, VKM considers the probability for significant non-target environmental effects from commercial use and distribution of M. pygmaeus to be low. Regarding possible human health effects, VKM recognises that the species of Macrolophus previously available in commercial products in Norway and Europe has probably always been M. pygmaeus and, consequently, experience and documentation referring to commercial use of M. caliginosus should be considered valid for M. pygmaeus

Final health and environmental risk assessment of genetically modified carnation Moonvelvet 26407-2

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on 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 within the Authority’s sectoral responsibility

Risk assessment of the metabolite M44 of bixafen, one of the active substances in Aviator Xpro EC 225

The Norwegian Scientific Committee for Food Safety (VKM) has on request by the Norwegian Food Safety Authority (NFSA) conducted a risk assessment of Aviator Xpro EC 225 as biological control product. The VKM Panel on Plant Protection Products has discussed the questions raised by The Norwegian Food Safety Authority on the basis of the new data, and has the following opinion: On the assessment of genotoxic properties of the M44 metabolite of bixafen, one of the active ingredients of Aviator Xpro EC 225 It is the view of VKM Panel on Plant Protection Products that the new in vivo mouse micronucleus study, supplemented together with a separate study demonstrating bioavailability, overrides the results of the in vitro clastogenicity studies. Taken together, it is the opinion of VKM that under the conditions studied, M44 should be considered as non-genotoxic. On the assessment of the relevance of the foetal malformations in M44 exposed animals VKMs Panel on Plant Protection products has assessed the arguments and new historical control data presented by the applicant, intended to show that metabolite M44 is not teratogenic. It is however the opinion of the Panel that the arguments and the new historical data provided by the applicant do not alter the panel’s previous conclusion; that the malformations observed in rabbits exposed to the metabolite M44 should be considered treatment related

Risk assessment of Malakite with the active substances dithianon and pyrimethanil

The Norwegian Scientific Committee for Food Safety (VKM) has on request by the Norwegian Food Safety Authority (NFSA) conducted a risk assessment of Malakite as biological control product. The plant protection product Malakite (BAS 669 01 F), containing the active substances dithianon and pyrimethanil, is a fungicide against scab in pome fruits. Products containing these active plant protection substances are approved in Norway, but not with both substances in the same product. The Swedish Chemicals Agency (KemI) has as zonal Rapporteur Member State (zRMS) of the Northern Zone evaluated the product Malakite and decided on non-approval due to the observation of unacceptable effects in exposed birds, aquatic organisms, non-target arthropods and earthworms

Final health and environmental risk assessment of genetically modified soybean A5547-127

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on 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 within the Authority’s sectoral responsibility

Risk assessment of the fungicide Aviator Xpro EC 225 with the active substances bixafen and prothioconazole

In a risk assessment requested by the Norwegian Food Safety Authority, The Norwegian Scientific Committee for Food Safety (VKM) concludes that repeated applications of a new fungicide, Aviator Xpro EC 225 containing active substance bixafen, may cause accumulation in soil under Norwegian conditions. There is also a potential for groundwater contamination by a metabolite. New fungicide Aviator Xpro EC 225 is a new fungicide for use in cereals, containing the active substance bixafen and the already approved substance prothioconazole. Risk assessment This risk assessment is based on recognized international methodology and documentation from a large number of experimental studies. The documentation is in part submitted by the pesticide notifier, supplemented with peer reviewed literature. The conclusions in the assessment will be used by the Norwegian Food Safety Authority when considering the application for registration of Aviator Xpro EC 225 in Norway. VKM was asked to assess possible health risk, fate and behavior in the environment, as well as eco-toxicological effects and risks related to the properties and use of Aviator Xpro EC 225. Health VKM concludes that effects on liver and coagulating parameters observed in experimental animals exposed to bixafen should be considered relevant for humans. The data do no suggest a tumour inducing potential of bixafen. However, VKM is of the opinion that it cannot be excluded that bixafen may have a potential for teratogenic effects. Safety may therefore depend on the use of protective equipment. Environment It is the opinion of VKM that repeated application of Aviator Xpro EC 225 may cause accumulation of bixafen in soil, and that there is also a potential for groundwater contamination from a metabolite. Bixafen has minimal risk for toxic effects to terrestrial organisms, but may have toxic effects on aquatic organisms unless a safety zone of 10 m to open water are used

Import of deciduous wood chips from eastern North America – pathway-initiated risk characterizations of relevant plant pests

On its own initiative the Norwegian Scientific Committee for Food Safety has conduct a risk characterization of ten insect pests and four fungal pests that may follow the import of deciduous wood chips from eastern North America, and that are potentially harmful to Norwegian forests and environment. The VKM Panel on Plant Health finds it important to get a better overview of plant pests, both listed and potential quarantine pests, which might follow the import of wood chips to Norway. As a first step toward a pest risk assessment of the commodity of wood chips, the panel decided to conduct a risk characterization. The ten insect species selected for risk characterization were: Agrilus anxius Agrilus planipennis Agrilus bilineatus Chrysobothris femorata Agrilus horni Agrilus granulatus liragus Agrilus granulatus granulatus Hylurgopinus rufipes Agrilus politus Scolytus schevyrewi Four fungal pest species The four selected fungal pest species were: Ceratocystis fagacearum Davidiella populorum Phellinus spiculosus Phellinus everhartii The ranking of the species given here is according to the likelihood of arriving with relevant pathways of wood chips, the presence of susceptible hosts in Norway, the similarity of climate between Norway and the areas of origin, and the severity of damages they may cause in Norwegian forests. The ranking order indicates which species could undergo full pest risk assessment first. However, the order is uncertain since the behaviour of the species under new conditions is unknown. Also, Agrilus anxius has already been risk assessed for Norway