EFSA Journal最新文献

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified Aspergillus oryzae NZYM-PH strain by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 0.226 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1283 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 5677. A search for the homology of the amino acid sequence of the triacylglycerol lipase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Nisso Chemical Europe GmbH and Nufarm Europe GmbH submitted two separate requests to the competent national authorities in the Netherlands and Austria, respectively, to modify the existing maximum residue levels (MRLs) for the active substance acetamiprid. The application assessed by Austria included requests to modify the MRLs for plums, soybeans, parsley, rosemary, basil and edible flowers, as well as honey. The request submitted to the Netherlands concerned modifications to the MRLs for soybeans and barley. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for soybeans, plums, parsley, rosemary, basil and edible flowers, and honey. For barley, a data gap was identified due to the lack of processing studies, which precluded the derivation of an MRL proposal. Adequate analytical methods for enforcement are available to control residues of acetamiprid in the plant matrices under consideration, at a validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of acetamiprid according to the reported agricultural practices (with the exception of the Good Agricultural Practice (GAP) for barley, for which an MRL is not recommended in the present output) is unlikely to present a risk to consumer health.

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request to the competent national authority in Belgium to modify the existing maximum residue levels (MRLs) for the active substance acequinocyl in blueberries, cranberries, currants (black, red and white) and gooseberries (green, red and yellow). The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops of interest. Adequate analytical methods for enforcement are available to control the residues of acequinocyl in plant matrices with high acid content at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of acequinocyl according to the reported agricultural practices is unlikely to present a risk to consumers' health.

The food enzyme endo-1,3(4)-β-glucanase (3-(1,3;1,4)-β-d-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified Trichoderma reesei strain TG-M5-337 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in 11 food manufacturing processes. Since residual amounts of the food enzyme—total organic solids (TOS) are removed in three processes, dietary exposure was calculated for the remaining eight food manufacturing processes. It was estimated to be up to 0.302 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level at 1958 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 6573. A search for the homology of the amino acid sequence of the endo-1,3(4)-β-glucanase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of L-tryptophan produced by fermentation using the genetically modified strain of Corynebacterium glutamicum, KCCM 80346, as a nutritional additive in feed for all animal species and categories. In the manufacturing process used to obtain the product under assessment, the cells from the production strain are inactivated but not removed from the final product. The FEEDAP Panel concluded that the additive does not give rise to any safety concern regarding the genetic modification of the strain. DNA from the strain is present in the final product, but its presence does not raise any safety issue since the strain does not harbour any gene of concern. No viable cells of the strain were detected in the final product. The use of l-tryptophan produced using C. glutamicum KCCM 80346 in feed is considered safe for non-ruminant species. There may be a risk for an increased production of toxic metabolites when unprotected tryptophan is used in ruminants. The use of the additive in animal nutrition is considered safe for the consumers of products from animals receiving the additive, and to the environment. With regard to the safety for the user, the additive is not irritant to the eyes or skin, but it should be considered a skin and respiratory sensitiser. Exposure by inhalation and dermal routes is considered a risk. The additive l-tryptophan produced using C. glutamicum KCCM 80346 is regarded as an effective source of the amino acid l-tryptophan for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.

The food enzyme prolyl oligopeptidase (EC 3.4.21.26) is produced with the genetically modified Aspergillus niger strain NZYM-MR by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in three food manufacturing processes. Since residual amounts of food enzyme—total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining two food manufacturing processes. It was estimated to be up to 0.557 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The panel identified a no observed adverse effect level of 1488 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2671. A search for the homology of the amino acid sequence of the prolyl oligopeptidase to known allergens was made, and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of galacto-oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from milk-derived lactose using β-galactosidases. The applicant proposed to extend the use of GOS to several food categories (non-alcoholic beverages, confectionery, chewing gum, cocoa and chocolate-based products and protein products). The target population is the general population. GOS is already authorised and included in the Union list of NFs for use in several foods, including infant formula, and in food supplements. The Panel estimated that the proposed extension of use would result in a highest 95th percentile intake of GOS from all food uses, of up to 48.5 g/day in adults. As compared to the exposure to GOS from the currently authorised food uses (at the highest P95), the proposed extension of use is expected to result in an increase in intake of GOS of up to 17%. The information provided on the proposed use levels and anticipated intake does not raise safety concerns. The Panel concludes that the proposed extension of use of GOS is safe under the proposed conditions of use.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of perlite as a technological feed additive for all terrestrial animal species. The FEEDAP Panel concluded that perlite is considered safe at 20,000 mg/kg complete feed for the use in feed for poultry for fattening or reared for laying/reproduction, ornamental birds, piglets (suckling and weaned) and pigs for fattening. No conclusion could be drawn on the safety of the product for the rest of terrestrial species/categories. The Panel concluded that the use of perlite is safe for the consumers and the environment. The Panel also concluded that the additive is not irritant to skin or eyes, but it is considered a dermal and respiratory sensitiser. Exposure by dermal and inhalation routes is considered a risk and should be minimised. The FEEDAP Panel concluded that perlite is efficacious as an anticaking agent in feed for terrestrial animal species.

Animal welfare is a recognised and important issue within the European Union, addressed through comprehensive regulations such as Regulations 1/2005 and 1099/2009, which emphasise the necessity to respect and protect the welfare of animals, particularly during transport and slaughter procedures. These legislative measures are part of an ongoing European commitment to ensure ethical treatment and minimise suffering for food-producing animals, aligning with broader food safety and public health goals. This project aimed to create a prototype of an updated cattle path designed to minimise stress and reduce reliance on coercive means such as electric prods, while also decreasing the risk of injury due to trauma or falls. The approach focused on implementing evidence-based methods and integrating preventative design features that support both animal behaviour and safety in handling environments. The ultimate goal was to guarantee the welfare and protection of animals as specified in European guidelines, while also achieving improvements in meat quality. By advancing these objectives, the project demonstrates how compliance with animal welfare standards can be harmonised with operational efficiency and product quality, benefitting both animals and consumers across the European Union.