SPIRIGEL COMPLETE

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  • Trgovački naziv:
  • SPIRIGEL COMPLETE
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  • Ljudi
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  • Medicinski uređaj

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  • SPIRIGEL COMPLETE
    Hrvatska
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Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 113963E
  • Zadnje ažuriranje:
  • 12-03-2018
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.

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  • Dokumenti u drugim jezicima dostupne ovdje

21-3-2019

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Published on: Wed, 20 Mar 2019 The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be establ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 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 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 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 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Probiotic Lactina® for chickens and rabbits

Probiotic Lactina® for chickens and rabbits

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the European Food Safety Authority 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 Probiotic Lactina® for chickens for fattening and rabbits. The additive is a preparation containing viable cells of six strains of lactic acid bacteria intended for use in feed at the proposed dose of 2.5 × 109CFU/kg complete feedingstuffs. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Multiple Losartan-containing drugs voluntarily recalled because of potential for nitrosamine impurity

Multiple Losartan-containing drugs voluntarily recalled because of potential for nitrosamine impurity

Affected products The following products containing Losartan manufactured by Hetero Labs Ltd. Unit 1 are being recalled. Health Canada maintains a complete list of sartan drugs that have been recalled because of nitrosamine impurities on its website.

Health Canada

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 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 safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Published on: Fri, 01 Mar 2019 The additive Calsporin® is a preparation of viable spores of Bacillus subtilis DSM 15544, at a minimum declared concentration of 1 × 1010 colony forming units (CFU)/g additive. The additive is authorised as a zootechnical additive (functional group: gut flora stabiliser) for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, laying hens and ornamental fish, dogs, in sows and in suckli...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of Bonvital (Enterococcus faecium, DSM 7134) as an additive in water for drinking for sows

Safety and efficacy of Bonvital (Enterococcus faecium, DSM 7134) as an additive in water for drinking for sows

Published on: Thu, 28 Feb 2019 The additive Bonvital is a preparation of Enterococcus faecium authorised in feed for piglets and pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. The current authorisation in sows does not include the use of the additive in water for drinking. The additive is intended for use in water for drinking for sows at a minimum level of 2.5 × 108 colony forming unit (CFU)/L. This level is half of that minimum authorised in com...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-2-2019

Pest categorisation of Scaphoideus luteolus

Pest categorisation of Scaphoideus luteolus

Published on: Wed, 27 Feb 2019 The Panel on Plant Health performed a pest categorisation of Scaphoideus luteolus, a well‐defined phloem sap‐feeding insect species in the family Cicadellidae (Insecta: Hemiptera). It can be identified using taxonomic keys. S. luteolus is only present in the eastern part of the USA. The main host plants of S. luteolus are species of the genus Ulmus (U. americana,U. alata, U. bergmanianna, U. szechuanica, U. rubra), but specimens have also been collected on Vitis sp., Salix...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Giant hogweed: limit its proliferation in order to reduce risks to human health and the environment

Giant hogweed: limit its proliferation in order to reduce risks to human health and the environment

Placed on the European Union's list of invasive species of concern, giant hogweed presents risks both to the flora of the environments it colonises and to human health. In response to this observation, ANSES was asked to summarise knowledge regarding this plant and make risk management recommendations. With its expert assessment work completed, the Agency recommends the creation of a monitoring system and the use of available control methods to eradicate giant hogweed populations in high-priority areas.

France - Agence Nationale du Médicament Vétérinaire

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Pest categorisation of the Ralstonia solanacearum species complex

Pest categorisation of the Ralstonia solanacearum species complex

Published on: Fri, 22 Feb 2019 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of the Ralstonia solanacearum species complex (RSSC), a distinguishable cosmopolitan group of bacterial plant pathogens (including R. solanacearum, Ralstonia pseudosolanacearum and two subspecies of Ralstonia syzygii) of the family Burkholderiaceae. The RSSC causes bacterial wilt in solanaceous crops, such as potato, tomato and pepper, but can also cause wilts i...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-2-2019

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Published on: Fri, 15 Feb 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 (AfB1) binder for all animal species; the additive is composed of bentonite feed grade and algae belonging to Ulva spp. The European Commission request follows an opinion of the FEEDAP Panel published in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Hill’s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D

Hill’s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D

Hill’s Pet Nutrition is voluntarily recalling select canned dog food products due to potentially elevated levels of vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of exposure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D, when consumed at very high levels, can lead to se...

FDA - U.S. Food and Drug Administration

31-1-2019

Important new safety information regarding the use of hydrochlorothiazide and the risk of non-melanoma skin cancer

Important new safety information regarding the use of hydrochlorothiazide and the risk of non-melanoma skin cancer

OTTAWA – Health Canada has completed a safety review of hydrochlorothiazide and has found that prolonged use of the drug could increase a person’s risk for non-melanoma skin cancer.

Health Canada

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Genotoxicity assessment of chemical mixtures

Genotoxicity assessment of chemical mixtures

Published on: Wed, 16 Jan 2019 This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: ‘Guidance on uncertainty analysis in scientific assessments’. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The g...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Guidance on Communication of Uncertainty in Scientific Assessments

Guidance on Communication of Uncertainty in Scientific Assessments

Published on: Wed, 16 Jan 2019 This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: ‘Guidance on uncertainty analysis in scientific assessments’. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The g...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Gymnosporangium spp. (non‐EU)

Pest categorisation of Gymnosporangium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Gymnosporangium spp. (non‐EU), a well‐defined and distinguishable group of fungal plant pathogens of the family Pucciniaceae affecting woody species. Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in th...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called He...

FDA - U.S. Food and Drug Administration

16-12-2018

Spokane Produce Voluntarily Recalls Northwest Cuisine Creations and Fresh&Local Sandwiches and Green Leaf Lettuce Filets

Spokane Produce Voluntarily Recalls Northwest Cuisine Creations and Fresh&Local Sandwiches and Green Leaf Lettuce Filets

Spokane Produce Inc. of Spokane, WA initiates a voluntary recall of sandwiches containing green leaf lettuce and foodservice lettuce filets following notice of a produce industry ingredient recall by Adam Bros. Farming Inc. Sandwich products bearing the Northwest Cuisine Creations and Fresh&Local labels. These prod- ucts are recalled because they may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most...

FDA - U.S. Food and Drug Administration

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 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 Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

FDA - U.S. Food and Drug Administration

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

16-8-2017

Testing the exchange of E2B files

Testing the exchange of E2B files

Testing the exchange of E2B ICSRs/SUSARs between the Danish Medicines Agency and companies/sponsors must be completed by Friday 29 September 2017.

Danish Medicines Agency

10-6-2016

Operation targets illegal medicines

Operation targets illegal medicines

Global medicine operation just completed. Operation Pangea resulted in 393 arrests and the suspension of more than 4,900 websites.

Danish Medicines Agency

9-2-2016

EMA: No changes to the safety profile of Gardasil

EMA: No changes to the safety profile of Gardasil

The European Medicines Agency (EMA) has recently completed its annual routine safety assessment of the HPV vaccine Gardasil®. The conclusion is that there are no changes to the safety profile.

Danish Medicines Agency

19-6-2015

Global operation against illicit medicines completed

Global operation against illicit medicines completed

A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites.

Danish Medicines Agency

3-10-2014

Consultation procedure about medicinal products and safety measure requirements not completed yet

Consultation procedure about medicinal products and safety measure requirements not completed yet

On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation. The consultation period expired on 17 September 2014, and on 3 October we were to inform the European Commission of the medicinal products we recommend including in the common EU lists. We have received 22 consultation responses. But on 24 September 2014 the European Commission amended the original guideline for...

Danish Medicines Agency

7-7-2014

Monitoring of medicines for births

Monitoring of medicines for births

The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour. The action plan was launched in the autumn of 2013 following a public debate about the use of these medicines, and it should be completed by the end of 2015.

Danish Medicines Agency

6-5-2014

Guidance material to doctors and users of contraceptive pills

Guidance material to doctors and users of contraceptive pills

The EU Pharmacovigilance Risk Assessment Committee (PRAC) recently completed a review of the risk of blood clots (VTE) with contraceptive pills and other combined hormonal contraceptives. Combined hormonal contraceptives contain two types of hormone, oestrogen and progesterone, and are available as pills, transdermal patches and vaginal rings.

Danish Medicines Agency

8-3-2012

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

We have completed our review of an application for general reimbursement for Valsartan/Hydrochlorothiazide "Actavis". The product is neither eligible for general nor general conditional reimbursement.

Danish Medicines Agency

25-1-2012

Review concluded regarding general reimbursement for Xarelto®

Review concluded regarding general reimbursement for Xarelto®

The Danish Medicines Agency has completed its review of an application for general reimbursement for two new strengths of Xarelto®. The product maintains general reimbursement.

Danish Medicines Agency

20-1-2012

Review concluded regarding general reimbursement for Zomig Nasal®

Review concluded regarding general reimbursement for Zomig Nasal®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Zomig Nasal®. The product has been granted general reimbursement.

Danish Medicines Agency

17-1-2012

Decision on general reimbursement for Yellox®

Decision on general reimbursement for Yellox®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Yellox®. The product has been granted general reimbursement.

Danish Medicines Agency

16-1-2012

Review concluded regarding general reimbursement for Multaq®

Review concluded regarding general reimbursement for Multaq®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Multaq®. The product is neither eligible for general nor general conditional reimbursement.

Danish Medicines Agency

15-3-2019

Implementation of our reorganization will begin on March 18, with a goal of full implementation being complete by Sept 30. Questions?  The Division of Industry and Consumer Education is ready to help.  https://go.usa.gov/xE6We 

Implementation of our reorganization will begin on March 18, with a goal of full implementation being complete by Sept 30. Questions? The Division of Industry and Consumer Education is ready to help. https://go.usa.gov/xE6We 

Implementation of our reorganization will begin on March 18, with a goal of full implementation being complete by Sept 30. Questions? The Division of Industry and Consumer Education is ready to help. https://go.usa.gov/xE6We 

FDA - U.S. Food and Drug Administration