EFSA Scientific Opinion Research Articles

Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-NL-2015-126) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87705 × MON 87708 × MON 89788.

Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON × MON 87708 × MON 89788 (EFSA-GMO-NL-2015-126). The applicant conducted a 90-day feeding study on GM soybean MON 87705 and provided a proposal for post-market monitoring considering the altered fatty acid profile of GM soybean MON 87705 × MON 87708 × MON 89788, to fulfil the deficiencies identified by EFSA GMO Panel, addressing elements that remained inconclusive from a previous EFSA scientific opinion issued in 2020. The GMO Panel concludes that the 90-day feeding study on GM soybean MON 87705 is in line with the requirements of Regulation (EU) No 503/2013 and that no treatment-related adverse effects were observed in rats after feeding diets containing soybean MON 87705 meals at 30% or 15% for 90 days. The GMO Panel reiterates the recommendation for a PMM for food in accordance with Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013 and concludes that the proposal provided by the applicant is in line with the recommendations described for the PMM plan of soybean MON 87705 × MON 87708 × MON 89788 in the adopted scientific opinion. Taking into account the previous assessment and the new information, the GMO Panel concludes that soybean MON 87705 × MON 87708 × MON 89788, as assessed in the scientific opinion on application EFSA-GMO-NL-2015-126 and in the supplementary toxicity study, is as safe as its non-GM comparator and the non-GM reference varieties tested and does not represent a nutritional concern in humans and animals, within the scope of this application.

Administrative guidance for the preparation of applications for the authorisation of individual recycling processes to produce recycled plastics materials and articles intended to come into contact with food1

Abstract This document provides guidance to applicants submitting applications for the authorisation of individual recycling processes that use a suitable technology to produce recycled plastic materials and articles intended to come into contact with food, which are to be evaluated by EFSA. Currently post‐consumer mechanical PET recycling is the only suitable technology listed in Annex I to Commission Regulation (EU) 2022/1616 that requires individual authorisation. Consequently, this guidance describes the administrative requirements for the preparation and online submission of the dossier to support applications, submitted to the competent authority of a Member State for a new authorisation or for the modification of an authorisation of an individual recycling process based on post‐consumer mechanical PET recycling as technology. It does not apply to novel technologies developed in accordance with Chapter IV of Commission Regulation (EU) 2022/1616. The Transparency Regulation amended the General Food Law by introducing new provisions in the pre‐submission phase and in the application procedure: general pre‐submission advice, notification of information related to studies commissioned or carried out to support an application, public disclosure of non‐confidential version of all information submitted in support of the application and related confidentiality decision‐making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangements laid down by EFSA, are reflected in this guidance. The guidance describes the procedure and the associated timelines for handling applications on individual recycling processes that use a suitable technology, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre‐submission phase) to the adoption and publication of EFSA's scientific opinion.

Re-evaluation of certain aspects of the EFSA Scientific Opinion of April 2010 on risk assessment of parasites in fishery products, based on new scientific data. Part 1: ToRs1-3.

Surveillance data published since 2010, although limited, showed that there is no evidence of zoonotic parasite infection in market quality Atlantic salmon, marine rainbow trout, gilthead seabream, turbot, meagre, Atlantic halibut, common carp and European catfish. No studies were found for greater amberjack, brown trout, African catfish, European eel and pikeperch. Anisakis pegreffii, A. simplex (s. s.) and Cryptocotyle lingua were found in European seabass, Atlantic bluefin tuna and/or cod, and Pseudamphistomum truncatum and Paracoenogonimus ovatus in tench, produced in open offshore cages or flow-through ponds or tanks. It is almost certain that fish produced in closed recirculating aquaculture systems (RAS) or flow-through facilities with filtered water intake and exclusively fed heat-treated feed are free of zoonotic parasites. Since the last EFSA opinion, the UV-press and artificial digestion methods have been developed into ISO standards to detect parasites in fish, while new UV-scanning, optical, molecular and OMICs technologies and methodologies have been developed for the detection, visualisation, isolation and/or identification of zoonotic parasites in fish. Freezing and heating continue to be the most efficient methods to kill parasites in fishery products. High-pressure processing may be suitable for some specific products. Pulsed electric field is a promising technology although further development is needed. Ultrasound treatments were not effective. Traditional dry salting of anchovies successfully inactivated Anisakis. Studies on other traditional processes - air-drying and double salting (brine salting plus dry salting) - suggest that anisakids are successfully inactivated, but more data covering these and other parasites in more fish species and products is required to determine if these processes are always effective. Marinade combinations with anchovies have not effectively inactivated anisakids. Natural products, essential oils and plant extracts, may kill parasites but safety and organoleptic data are lacking. Advanced processing techniques for intelligent gutting and trimming are being developed to remove parasites from fish.

Threat or treat: Exposure assessment and risk characterisation of chemical contaminants in soft drinks and chocolate bars in various Polish population age groups.

In the frame of the European Food Risk Assessment (EU-FORA) fellowship programme, two studies on chemical contaminants in food matrices were carried out in Warsaw, Poland, at the Department of Food Safety and Chemical Analysis, Institute of Agricultural and Food Biotechnology. The first study addressed health concerns about the dietary exposure to bisphenol A (BPA) contamination due to consumption of soft drink by Polish population. BPA is an organic additive used in the production of epoxy resins and polycarbonate plastics and because of this it is used in the internal coating of cans and in plastic bottle production. Depending on several factors, BPA can migrate from these materials to the soft drink and so, it can be ingested by consumers causing hormonal and reproductive disorders. To estimate the Polish population exposure to BPA, several soft drinks belonging to different brands were purchased from a supermarket in the city of Warsaw and analysed. The result of the analysis highlight that mean BPA exposure in the Polish population exceeds the tolerable daily intake proposed by the EFSA scientific opinion, raising health concerns. On the other hand, the second study, focused on cadmium exposure due to chocolate consumption by Polish population, did not raise any health concern. Cadmium is a heavy metal that naturally occurs in its inorganic form in the environment and its presence in chocolate derives only from the cocoa beans and not from contamination during processing. Its accumulation in the human body can create several adverse effects, including renal dysfunction and failure. To estimate the Polish population exposure to cadmium, several chocolate bars were purchased from a supermarket in the city of Warsaw and analysed. The results of the analysis show that cadmium exposure in the Polish population does not exceed the tolerable weekly intake proposed by the EFSA scientific opinion.

A Critical Appraisal of the Separation Protocols Proposed for the Implementation of the Health Claim on “Olive Oil Polyphenols” (EC Regulation 432/2012)

The analysis of the secoiridoid type of phenolic compounds present in virgin olive oil has become a challenging area of research since the first evidence of their presence in the polar fraction of the oil. Separation techniques, mainly liquid chromatographic ones, prevailed over the years of application toward elucidation of their structure, content determination and collection of evidence on cultivar, origin, processing and storage conditions dependence. One of the latest challenges in their analysis was related to the need to address the requirement set by EC Regulation 432/2012 for the implementation of the health claim on ‘olive oil polyphenols’. The present work considers in a chronological order the original articles, viewpoints, review articles and other published efforts that appeared in the literature after the issuing of the relevant EFSA scientific opinion in 2011. The EFSA health claim created a lot of expectations among producers of virgin olive oil and boosted research for the development of a ‘fit for the purpose’ analytical protocol. Emphasis is given to the dedicated separation protocols that have been developed in the last 10 years and to the progress in their validation in comparison to the features of the method that were recently adopted by the International Olive Council.

Frequency of consumption of coffee beverages in the city of Mostar and caffeine intake

The aim of this study was to examine the frequency of consumption of coffee beverages in the city of Mostar. In 2019, an analysis of caffeine content was performed on HPLC in 10 different samples of coffee beverages. Samples of coffee were taken from the market of the city of Mostar by random selection. In addition to the High-performance liquid chromatography (HPLC) method, the study was conducted using empirical and descriptive methods. An assessment of daily (EDI) and weekly intake (EWI) was also performed were on the base of determined values of caffeine content in 10 different coffee samples. The acute toxic dose of caffeine is not well defined, but it is considered more than 10 grams of caffeine per day for adults, while in most countries it is not recommended that more than 450 mg of caffeine be consumed per day. The samples were found to be in accordance with the EFSA Scientific Opinion (European Food Safety Authority) stating that a single dose of 200 mg of caffeine from all sources does not pose a risk to the health of healthy adults. (EFSA, 2015).

Statement complementing the EFSA Scientific Opinion on the assessment of genetically modified oilseed rape MS11 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-BE-2016-138).

In a previous scientific opinion on application EFSA‐GMO‐BE‐2016‐138, the EFSA Panel on Genetically Modified Organisms (GMO Panel) could not conclude on the comparative analysis and on the food/feed safety assessment of genetically modified (GM) oilseed rape (OSR) MS11 because of the lack of an appropriate compositional data set. Following a request from the European Commission, the GMO Panel assessed additional information related to OSR MS11 to complement the original scientific opinion. The GMO Panel concluded that the information submitted (on the composition of the two‐event stack MS11 × RF3) could not be used for the assessment of the composition of OSR MS11 and requested the applicant to perform a complementary set of field trials to generate additional data. The applicant did not perform the requested field trials and did not provide any new experimental data on the composition of OSR MS11. Hence, the GMO Panel is still not in the position to conclude on either the compositional analysis or the toxicological, allergenicity or nutritional assessment of OSR MS11. Therefore, the previous conclusions of the GMO Panel still hold.

Burden of disease of dietary exposure to aflatoxins in European countries

Abstract Aflatoxins (AFTs) are genotoxic and carcinogenic food contaminants causing hepatocellular carcinoma, the third leading cause of cancer deaths worldwide. In 2015, WHO estimated the burden of disease associated with exposure to AFTs and concluded that this exposure corresponds to 636,869 Disability-adjusted Life Years (DALYs) at global level. Particularly for Portugal and recently, there were estimated 0.08-0.30 DALYs/100,000 considering consumption and occurrence in food data, and 1.7 DALYs/100,000 based on human biomonitoring data. The present study considered the exposure data presented in the EFSA scientific opinion “Risk assessment of aflatoxins in food” where data from occurrence of AFTs in food and from food consumption were gathered to estimate the exposure to AFTs in 19 European countries. A deterministic and a bottom-up approach was developed to estimate the health impact of the exposure to AFTs for adult population through the calculation of DALYs associated to the number of estimated extra-cases of hepatocellular carcinoma (HCC). Results showed similar values for all the 19 European countries considered. For adult population and considering the data provided by EFSA using the upper-bound approach (worst-case scenario), the estimated number of DALYs ranged from 0.32 (Spain) to 1.10 (United Kingdom) DALYs/100,000. A total of 11.76 DALYs/100,000 was globally estimated for the considered European countries. The highest burden was estimated for the United Kingdom, that together with The Netherlands, Ireland, Czech Republic, and Austria were the highest contributors to the global estimated European burden associated to the exposure to AFTs. The present study generated reliable and crucial data to characterize the burden associated to exposure to AFTs in the European population. The obtained results constitute an important contribution to define priorities and support the need for further policy actions to protect European citizen's health.

PFASs intake from fish, eggs and drinking water in Greece in relation to the safety limits for weekly intake proposed in the EFSA scientific opinion of 2020

Food consumption has been recognized as the most significant contributor to human exposure to polyfluoroalkyl and perfluoroalkyl substances (PFASs) for the general population. In 2020, EFSA introduced for the first time safety limit of 4.4 ng/kg body weight (bw) for weekly intake for the sum of perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorononanoic acid (PFNA) and perfluorohexane sulfonic acid (PFHxS) which are all perfluoralkyl acids (PFAAs) that belong to PFASs group. Fish and eggs have been found to contribute significantly, almost 50 % to PFOS and PFOA dietary intake of the Greek population. In the present study, estimation of human intake of these four PFASs from fish, eggs and drinking water consumption is attempted. Data from EFSA food consumption database for fish and eggs are used for assessment. Mean weekly intake estimated is above the tolerable weekly intake (TWI) recently proposed, mainly due to fish consumption. Exceedance of the proposed TWI emphasizes the need for continuous monitoring of levels of PFASs in food in parallel with efforts to lower these levels.

Statement complementing the EFSA Scientific Opinion on application (EFSA-GMO-NL-2010-85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769×MON 89788.

The European Commission mandated EFSA to complement its original scientific opinion on soybean MON 87769 × MON 89788 (EFSA‐GMO‐NL‐2010‐85) considering additional information on the human nutritional assessment of refined bleached deodorised oil produced from the two‐event stack soybean (RBD GM‐oil). The assessment was mainly based on a replacement scenario with a list of target foods where RBD GM‐oil is intended to be added. Intake estimations for several fatty acids present in the RBD GM‐oil, in particular γ‐linolenic acid (GLA), stearidonic acid (SDA) and linoleic acid (LA) were based on the consumption of the corresponding foods that are likely to be displaced. The assessment of LA considered the established adequate intake of 4% of total energy intake (E%) and that LA deficiency has not been observed with intakes > 1 E%. The assessment of GLA and SDA was conducted using maximum doses without adverse effects from intervention human studies as reference (4.2 grams/day for SDA and 2.8 grams/day for GLA) since no tolerable upper intake levels are set for these fatty acids. The decrease observed in the levels of LA in RBD GM‐oil as compared to oil from conventional soybean does not represent a nutritional concern as intakes were in all cases above 1 E%. For GLA, all intake estimations were below the reference dose indicating no safety concern. SDA intake estimations do not pose any safety concerns based on the overly conservative nature of the estimates, the absence of toxicological hazards and the rapid metabolism of SDA in humans. The GMO Panel concluded that the consumption of soybean MON 87769 × MON 89788 and their derived products, in particular its RBD oil, does not represent a nutritional concern in humans. A post‐market monitoring plan is recommended to confirm the predicted consumption and the application of conditions of uses considered during the pre‐market risk assessment.

Implications of the EFSA Scientific Opinion on Site Directed Nucleases 1 and 2 for Risk Assessment of Genome-Edited Plants in the EU

Genome editing is a set of techniques for introducing targeted changes in genomes. It may be achieved by enzymes collectively called site-directed nucleases (SDN). Site-specificity of SDNs is provided either by the DNA binding domain of the protein molecule itself or by RNA molecule(s) that direct SDN to a specific site in the genome. In contrast to transgenesis resulting in the insertion of exogenous DNA, genome editing only affects specific endogenous sequences. Therefore, multiple jurisdictions around the world have exempted certain types of genome-edited organisms from national biosafety regulations completely, or on a case-by-case basis. In the EU, however, the ruling of the Court of Justice on the scope of mutagenesis exemption case C-528/16 indicated that the genome-edited organisms are subject to the GMO Directive, but the practical implications for stakeholders wishing to develop and authorize genome-edited products in the EU remain unclear. European Food Safety Authority in response to a request by European Commission has produced a scientific opinion on plants developed by SDN-1, SDN-2, and oligonucleotide-directed mutagenesis (ODM) genome editing techniques. In this review, I will (1) provide a conceptual background on GMO risk assessment in the EU; (2) will introduce the main conclusions of the EFSA opinion, and (3) will outline the potential impact on the risk assessment of genome-edited plants.

Administrative guidance for the preparation of applications on substances to be used in active and intelligent materials and articles intended to come into contact with food

This document provides guidance to applicants submitting applications on substances that may be used in components of active and intelligent materials and articles intended to come into contact with food, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and online submission of the dossier to support an application for a new authorisation or for the modification of an existing authorisation of substances used in components of active and intelligent materials and articles intended to come into contact with food, for applications submitted to the competent authority of a Member State as of 27 March 2021. The Transparency Regulation amended the General Food Law by introducing new provisions in the pre-submission phase and in the application procedure: general pre-submission advice, notification of information related to studies commissioned or carried out to support an application, public disclosure of non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangements laid down by EFSA, are reflected in this guidance. The guidance describes the procedure and the associated timelines for handling applications on active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre-submission phase) to the adoption and publication of EFSA's scientific opinion.

Administrative guidance for the preparation of applications on genetically modified plants

This document provides guidance to applicants submitting applications on genetically modified plants for food and feed uses, import and processing, and/or cultivation in the European Union, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and online submission of the dossier to support an application for a new authorisation and for the modification of an existing authorisation for applications submitted to the competent authority of a Member State as of 27 March 2021. The Transparency Regulation amended the General Food Law by introducing new provisions in the pre-submission phase and in the application procedure: general pre-submission advice, notification of information related to studies commissioned or carried out to support an application,public disclosure of non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangements laid down by EFSA, are reflected in this guidance. The guidance describes the procedure and the associated timelines for handling applications on genetically modified plants, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre-submission phase) to the adoption and publication of EFSA's scientific opinion.

Administrative guidance for the preparation of applications on smoke flavouring primary products

This document provides guidance to applicants submitting applications onsmoke flavouring primary products, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and online submission of the dossier to support an application for a new authorisation, for the modification or the renewal of an existing authorisation of smoke flavouring primary products,for applications submitted as of 27 March 2021to the competent authority of a Member State, or to the European Commission in case of renewal applications. The Transparency Regulation amended the General Food Lawby introducing new provisionsin the pre-submission phase and in the application procedure: general pre-submission advice, specific aspects for intended applications for renewal (notification of intended studies, including their design, public consultation on the intended studies, renewal pre-submission advice by EFSA), notificationof information related to studies commissioned or carried out to support an application, public disclosure of non-confidential version of all information submitted in support of the application and related confidentialitydecision-making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangementslaid downby EFSA, are reflected in this guidance. The guidance describes the procedure and the associated timelines for handlingapplications onsmoke flavouring primary products, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre-submission phase) to the adoption and publication of EFSA's scientific opinion.

Administrative guidance for the preparation of applications on substances to be used in plastic food contact materials

This document provides guidance to applicants submitting applications on substances to be used in plastic materials and articles intended to come into contact with food, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and online submission of the dossier to support an application for a new authorisation or for the modification of an existing authorisation for substances to be used in the manufacture of plastic food contactmaterials and articles for applications submitted to the competent authority of a Member State as of 27 March 2021. The Transparency Regulation amended the General Food Law by introducing new provisions in the pre-submission phase and in the application procedure: general pre-submission advice, notification of information related to studies commissioned or carried out to support an application, public disclosure of non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangements laid down by EFSA, are reflected in this guidance. The guidance describes the procedure and the associated timelines for handling applications on substances to be used in plastic food contact materials, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre-submission phase) to the adoption and publication of EFSA's scientific opinion.

Administrative guidance for the preparation of renewal applications on genetically modified food and feed

This document provides guidance to applicants submitting applications for renewal of authorisation of genetically modified food and feed, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and online submission of the dossier to support renewal applications submitted to the European Commission as of 27 March 2021. The Transparency Regulation amended the General Food Law by introducing new provisions in the pre-submission phase and in the application procedure: general pre-submission advice, specific aspects for intended applications for renewal (notification of intended studies, including their design, public consultation on the intended studies, renewal pre-submission advice by EFSA), notification of information related to studies commissioned or carried out to support an application, public disclosure of non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangementslaid down by EFSA, are reflectedin this guidance. The guidance describes the procedure and the associated timelines for handling applicationsfor renewal of genetically modified food and feed, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the renewal application (pre-submission phase) to the adoption and publication of EFSA's scientific opinion.

EFSA Scientific Opinion on the welfare of cattle at slaughter

EFSA Scientific Opinion on the welfare of cattle at slaughter

Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis.

The European Commission requested the EFSA Panel on Genetically Modified Organisms (GMO) to assess whether section 4 (hazard identification) and the conclusions of EFSA's Scientific opinion on the risk assessment of plants developed using zinc finger nuclease type 3 technique (ZFN‐3) and other site‐directed nucleases (SDN) with similar function are valid for plants developed via SDN‐1, SDN‐2 and oligonucleotide‐directed mutagenesis (ODM). In delivering this Opinion, the GMO Panel compared the hazards associated with plants produced via SDN‐1, SDN‐2 and ODM with those associated with plants obtained via both SDN‐3 and conventional breeding. Unlike for SDN‐3 methods, the application of SDN‐1, SDN‐2 and ODM approaches aims to modify genomic sequences in a way which can result in plants not containing any transgene, intragene or cisgene. Consequently, the GMO Panel concludes that those considerations which are specifically related to the presence of a transgene, intragene or cisgene included in section 4 and the conclusions of the Opinion on SDN‐3 are not relevant to plants obtained via SDN‐1, SDN‐2 or ODM as defined in this Opinion. Overall, the GMO Panel did not identify new hazards specifically linked to the genomic modification produced via SDN‐1, SDN‐2 or ODM as compared with both SDN‐3 and conventional breeding. Furthermore, the GMO Panel considers that the existing Guidance for risk assessment of food and feed from genetically modified plants and the Guidance on the environmental risk assessment of genetically modified plants are sufficient but are only partially applicable to plants generated via SDN‐1, SDN‐2 or ODM. Indeed, those guidance documents’ requirements that are linked to the presence of exogenous DNA are not relevant for the risk assessment of plants developed via SDN‐1, SDN‐2 or ODM approaches if the genome of the final product does not contain exogenous DNA.

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2009‐75) for placing on the market of genetically modified oilseed rape Ms8 × Rf3 × GT73 and subcombinations, which have not been authorised previously (i.e. Ms8 × GT73 and Rf3 × GT73) independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for

The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed oilseed rape Ms8 × Rf3 × GT73 and its subcombinations Ms8 × GT73 and Rf3 × GT73 according to the scope as defined in the application EFSA‐GMO‐NL‐2009‐75, and was not in the position to complete the safety assessment of products rich in protein, such as rapeseed protein isolates or products of this nature in animal feeding. Following a mandate from the European Commission, the GMO Panel assessed a 28‐day toxicity study in mice with the glyphosate oxidoreductase (GOXv247) protein, provided to complement information related to application EFSA‐GMO‐NL‐2009‐75 for the placing on the market of oilseed rape Ms8 × Rf3 × GT73 and its subcombinations Ms8 × GT73 and Rf3 × GT73, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The 28‐day toxicity study on Escherichia coli‐ produced GOXv247 protein did not show adverse effects in mice, at the gavage doses up to 1000 mg/kg body weight (bw) per day. Taking into account its previous assessment on EFSA‐GMO‐NL‐2009‐75 and the outcome of the 28‐day toxicity study in mice with the GOXv247 protein provided in this mandate, the GMO Panel, based on a weight of evidence approach, concludes that food and feed containing, consisting and produced from genetically modified oilseed rape Ms8 × Rf3 × GT73 and its sub combinations Ms8 × GT73 and Rf3 × GT73, are as safe as its conventional counterpart, according to the scope as defined in the application EFSA‐GMO‐NL‐2009‐75.

Feasibility of assessing vegetative and generative endpoints of crop- and non- crop terrestrial plant species for non-target terrestrial plant (NTTP) regulatory testing under greenhouse conditions.

Agriculture is the dominating land-use in the EU member states covering nearly half of the surface area. Using herbicides to reduce weed competition in agricultural areas can adversely affect Non-Target Terrestrial Plants (NTTP) growing in field margins. According to the EFSA Scientific Opinion on NTTPs an important protection goal is to maintain the biodiversity of plant species in agricultural areas. EFSA recommends to include also non-crop species mentioned in OECD guidelines (OECD 208 and 227) in the testing and to assess not only vegetative but also generative endpoints during the plant life-cycle such as flowering and seed production. The objectives of this study were to evaluate the feasibility of assessing generative endpoints of crop and non-crop species for NTTP regulatory testing under greenhouse conditions and to assess if generative endpoints are more sensitive than vegetative endpoints. The experimental design consisted of one control and four herbicide (Atlantis® WG) application rates, with 6 replicates each. The application rates of the test substance were the maximum field rate and 30%, 10% and 3% of the field rate. Biomass, plant height, flowering, seed production as well as seedling emergence of the F1 generation were assessed. The study shows a feasible approach to assess vegetative and generative endpoints of (non-) crops species under greenhouse conditions on the basis of the OECD guideline 227. The vegetative endpoints plant height and biomass were not more sensitive if assessed during the generative growth stage when compared to the vegetative growth stage of the plants. In contrast to that, the generative endpoint seed production was partly more sensitive in comparison to the vegetative endpoints biomass and plant height. For regulatory NTTP studies, 5 or more test substance rates at non-lethal levels should be tested so to allow the determination of ER10/50 values for vegetative and generative endpoints.