The European Food Safety Authority (EFSA) is the agency of the European Union (EU) that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. EFSA was established in February 2002, is based in Parma, Italy and had a budget for 2008 of €65.9 million.

The work of EFSA covers all matters with a direct or indirect impact on food and feed safety, including animal health and welfare, plant protection and plant health and nutrition. EFSA supports the European Commission, the European Parliament and EU member states in taking effective and timely risk management decisions that ensure the protection of the healthof European consumers and the safety of the food and feed chain. EFSA also communicates to the public in an open and transparent way on all matters within its remit.

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Published on: 29 May 2020

Following a request from the European Commission, the EFSA 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 APSA PHYTAFEED® 20,000 GR/L (6‐phytase) as a zootechnical feed additive for laying hens and other poultry species for laying. The additive is a preparation of 6‐phytase produced by a genetically modified strain of Komagataella phaffii and has been previously assessed by the FEEDAP Panel in the context of three applications for its use in different species/categories. The Panel concluded in those opinions that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be irritant to skin or eyes or a dermal sensitiser but it should be considered as a respiratory sensitiser. The Panel considered that the new use in laying hens and other poultry species for laying would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial in laying hens and a subchronic oral toxicity study were made available to support the safety of the additive for the target species/categories subject of this new application; from the results obtained, the Panel concluded that the additive is safe for laying hens at the recommended level of use (300 U/kg feed) with a wide margin of safety and therefore the conclusion was extrapolated to other laying birds. The FEEDAP Panel concluded that the additive has the potential to be efficacious in laying hens at the level of 300 U/kg feed and this conclusion was extrapolated to other laying birds.


© European Food Safety Authority, 2015

Safety and efficacy of APSA PHYTAFEED® (6‐phytase) as a feed additive for laying hens and other laying birds


Published on: 29 May 2020

The food enzyme with β‐glucanase and β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) activities is produced with the non‐genetically modified Trichoderma reesei (strain DP‐Nya67) by DuPont. The food enzyme is intended to be used in brewing processes, grain treatment for the production of starch and gluten fractions, and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation and during grain treatment, dietary exposure was only calculated for brewing processes. Based on the maximum recommended use levels for brewing processes, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 4.585 mg TOS/kg body weight (bw) per day. Since the compositional data provided was insufficient to characterise the food enzyme batches used for toxicological testing, their suitability for use in the toxicological tests could not be established. As result, the toxicological studies provided were not further considered by the Panel. Similarities of the amino acid sequences to those of known allergens were searched and no matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is considered to be low. In the absence of compositional data sufficient to characterise the food enzyme batches used for toxicological testing, the Panel is unable to complete its assessment of the safety of the food enzyme.


© European Food Safety Authority, 2015

Safety evaluation of the food enzyme with β‐glucanase and β‐xylanase activities from the Trichoderma reesei strain DP‐Nya67


Published on: 29 May 2020

Following a request from European Commission, the Panel on Additives and Products or Substances used in animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of authorisation of montmorillonite‐illite (FIMIX 1g557) for all animal species. The FEEDAP Panel adopted in 2014 an opinion on the safety and in 2015 on the efficacy of this additive. The additive montmorillonite‐illite (FIMIX 1g557) is currently authorised for use in feedingstuffs for all animal species as an anticaking agent with a minimum and a maximum content of 20,000 mg/kg. The applicant proposed to use the additive in premixtures and complementary feeds for all animal species and categories at a minimum concentration of 20,000 mg/kg premixture and 10,000 mg/kg complementary feeds. The FEEDAP Panel considers that the proposed modification (reduction of the inclusion level in feed) would not affect the conclusions reached in the previous assessment as related to the safety for the target species, consumers, users and the environment. Montmorillonite‐illite is efficacious as an anticaking agent in premixtures for all animal species at inclusions levels starting at 20,000 mg/kg premixture and in complementary feeds at inclusions levels starting at 10,000 mg/kg. When the premixtures or complementary feeds are incorporated into complete feed, the concentration of montmorillonite‐illite would range from 50 to 100 mg/kg complete feed for poultry and all other animal species, respectively. There is no evidence that the anticaking effect of the additive will persist at these concentrations in complete feed. In the absence of specific data, the FEEDAP Panel is not in the position to comment on the efficacy of the additive at these concentrations when used in complete feed.


© European Food Safety Authority, 2015

Safety and efficacy of montmorillonite‐illite (FIMIX 1g557) for all animal species


Published on: 29 May 2020

In December 2013, EFSA received a first mandate from the European Commission DG SANTE to gather information on the pests of apple fruit (Malus domestica) in the EU territory (M‐2014‐0016). To satisfy the mandate, EFSA developed an overall approach to systematically collect information on EU apple pests and to organise it within a bespoke database with support from the Austrian Agency for Health and Food Safety. Test data were collected for 12 apple pests (6 insects and 6 pathogens). Based on the experience gathered, the initial database structure was adapted and refined by EFSA, permitting more efficient data gathering. In September 2017, as a follow‐up to the original mandate, EFSA was requested by the European Commission DG SANTE to test the suitability of the revised database in supporting risk assessors in third countries to carry out pest risk assessments of apple fruit as a commodity (M‐2017‐0203). As a first step, the data set on the 12 pests was migrated into the newly revised database structure. This was then converted into the MicroStrategy platform to provide a user‐friendly interface for data search and visualisation. At the same time, a new data entry tool using the systematic literature review software DistillerSR was created to enhance data extraction for future data collections. The interactive data reports were shared with the Canadian Food Inspection Agency (CFIA) and the Ministry for Primary Industries (MPI) in New Zealand for their testing and feedback as potential future users of the database. The overall feedback collected from CFIA and MPI confirms that the EU database on apple fruit pests could become an important tool to provide third countries the necessary technical and biological information for their pest risk assessments. Addressing feedback from CFIA and MPI has further improved the database structure and metadata. The database of apple pests can be included in the EFSA Scientific Data Warehouse and extended to provide a comprehensive list of pests and host plants.


© European Food Safety Authority, 2015

Database on apple fruit pests of the EU to support pest risk assessments


Published on: 27 May 2020

The food enzyme with 4‐α‐d‐{(1‐>4)‐α‐d‐glucano}trehalose trehalohydrolase ((4‐α‐d‐[(1,4‐α‐d‐glucano]trehalose glucanohydrolase (trehalose‐producing)), EC 3.2.1.141) and (1‐>4)‐α‐d‐glucan 1‐α‐d‐glucosylmutase ((1,4)‐α‐d‐glucan 1‐α‐d‐glucosylmutase, EC 5.4.99.15) activities is produced with a non‐genetically modified microorganism Gryllotalpicola ginsengisoli (formally Arthrobacter ramosus) by Hayashibara Co., Ltd. The applicant states that the food enzyme will not be placed on the open market, but will only be used in‐house in starch processing for trehalose production. Since residual amounts of total organic solids are removed by the purification steps applied during the production of trehalose, toxicological studies were considered not necessary and no dietary exposure was calculated. Similarities of the amino acid sequences to those of known allergens were searched and no matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is considered to be low. Based on the data provided, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.


© European Food Safety Authority, 2015

Safety evaluation of the food enzyme with 4‐α‐d‐{(1‐>4)‐α‐d‐glucano}trehalose trehalohydrolase and (1‐>4)‐α‐d‐glucan 1‐α‐d‐glucosylmutase activities from the Gryllotalpicola ginsengisoli strain S34