Review of the existing maximum residue levels for triadimenol according to Article 12 of Regulation (EC) No 396/2005

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triadimenol. In order to assess the occurrence of triadimenol residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

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Review of the existing maximum residue levels for fenpyroximate according to Article 12 of Regulation (EC) No 396/2005

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenpyroximate. In order to assess the occurrence of fenpyroximate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission, as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.

Peer review of the pesticide risk assessment for the active substance pyridaben in light of confirmatory data submitted

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State the Netherlands, for the pesticide active substance pyridaben are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of pyridaben as an insecticide on citrus and tomatoes. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified.

Statement on the refined exposure assessment of tertiary-butyl hydroquinone (E 319)

The current ANS Panel statement is a refined exposure assessment of tertiary-butyl hydroquinone (TBHQ, E 319) when used as a food additive. TBHQ (E 319) is authorised as a food additive in the EU with an acceptable daily intake (ADI) of 0.7 mg/kg body weight (bw), as established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1998 and confirmed by EFSA in 2004. In 2004, the EFSA Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) adopted an opinion on the safety in use of TBHQ (E 319) in fats and oils used for human consumption. In that opinion, the Panel concluded that the exposure in adults did not exceed the ADI, however, if TBHQ (E 319) was to be used in infant formulae, the exposure in infants could exceed the ADI. Following this conclusion, EFSA performed a refined exposure assessment for TBHQ (E 319) based on individual food consumption data available within the EFSA Comprehensive European Food Consumption Database, on newly submitted data on the actual usage levels of TBHQ (E 319) and analytical data provided by the food industry and Member States. EFSA ANS Panel concluded that, using the maximum permitted levels, exposure estimates exceed the ADI of 0.7 mg/kg bw per day at the high level for toddlers and children, however, in the refined exposure scenarios, the ADI was not exceeded in any of the population groups.

Safety of synthetic trans-resveratrol as a novel food pursuant to Regulation (EC) No 258/97

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked for an opinion on the safety of synthetic trans-resveratrol as a novel food with a purity of ≥99% (w/w). The Panel considers that the information provided on the composition and specifications of the novel food is sufficient. The applicant intends to market the novel food as a food supplement in capsule or tablet form at daily doses up to 150 mg/day. The Panel considers that resveratrol does not have a nutritionally relevant role in the human diet and that the consumption of the novel food is not nutritionally disadvantageous. In accordance with the EFSA Scientific opinion on genotoxicity testing strategies, the Panel considers that the negative in vivo genotoxicity assay is sufficient to rule out the concern based on the positive in vitro chromosomal aberration tests. Reduced body weight gain is seen consistently in animal studies. On the basis of the BMDL05 of 344 mg/kg body weight (bw) per day derived from body weight data of female rats in a subchronic toxicity study and the intended intake of 150 mg/day, the margin of exposure is 172. For pregnant rats, it is below 62. Considering the weight of evidence, the Panel concludes that the intended intake level of 150 mg/day for adults does not raise safety concerns. The Panel notes that diarrhoea or other gastrointestinal symptoms were reported in four uncontrolled intervention studies at doses of 1 g resveratrol/day or higher. The Panel considers that the metabolite trans-resveratrol sulfate could inhibit CYP enzymes in humans and may interact with medicines which are mainly metabolised by CYP2C9. The Panel concludes that the novel food, synthetic trans-resveratrol, is safe under the proposed conditions of use.

Safety of UV-treated milk as a novel food pursuant to Regulation (EC) No 258/97

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on UV-treated milk as a novel food submitted pursuant to Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States. The novel food is cow’s milk (whole, semi-skimmed or skimmed) to which a treatment with ultraviolet (UV) radiation is applied after pasteurisation in order to extend the shelf life of the milk. This treatment results in an increase in the vitamin D3 concentrations. The Panel considers that the provided compositional data, the specifications and the data from batch testing do not give rise to safety concerns. The data provided on the production process are sufficient and do not give rise to safety concerns. The target group is the general population with the exclusion of infants (up to 1 year of age). The Panel considers that it is unlikely that tolerable upper intake levels established by EFSA for children aged 1–10 years, adolescents and adults will be exceeded. The Panel considers that the novel food is not nutritionally disadvantageous. The data provided do not give rise to concerns with regard to the microbiological quality. The Panel considers that the risk of allergic reactions to the novel food is not dissimilar to that associated with conventional milk. The Panel concludes that the novel food, UV-treated milk, is safe under the intended conditions of use as specified by the applicant.

Safety assessment of the processes ‘Sumilon Eco PET SARL’ and ‘ITD’, based on Starlinger IV+® technology, used to recycle post-consumer PET into food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling processes Sumilon Eco PET SARL and ITD (EU register No. RECYC0125 and RECYC0127, respectively) based on the Starlinger IV+® technology. The input of the processes is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, containing no more than 5% of PET from non-food applications. These flakes are dried and crystallised in a reactor, then extruded into pellets which are further crystallised in a second reactor. Crystallised pellets are then pre-heated in a third reactor and fed to the solid state polycondensation (SSP) reactor. Having examined the challenge tests provided, the Panel concluded that the three steps, drying and crystallisation, extrusion and crystallisation and SSP are the critical steps that determine the decontamination efficiency. The operating parameters controlling the performance are temperature, gas flow and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step and the SSP step. It was demonstrated that the processes Sumilon Eco PET SARL and ITD are able to ensure that the migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from these processes intended to be used up to 100% for the manufacture of bottles (for ITD) or materials and articles (for Sumilon Eco PET SARL) for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of the recycled PET obtained from the process Sumilon Eco PET SARL are not intended to be used, and should not be used in microwave and conventional ovens.