Toxer total

Informazioni principali

  • Nome commerciale:
  • Toxer total
  • Forma farmaceutica:
  • SL concentrato solubile in acqua
  • Utilizzare per:
  • Piante
  • Tipo di medicina:
  • Agrochimico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Toxer total
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Erbicida

Altre informazioni

Status

  • Fonte:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Numero dell'autorizzazione:
  • W-6477-1
  • Ultimo aggiornamento:
  • 18-11-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Denominazione commerciale: Toxer total

Elenco dei prodotti fitosanitari (stato: 06.11.2018)

Autorizzazione revocata: Termine per la svendita: 31.10.2018, Termine per l'utilizzo: 31.10.2019

Categoria di

prodotti:

Titolare dell'autorizzazione:

Numero federale di

omologazione:

Erbicida

Omya (Schweiz) AG

W-6477-1

Principio:

Tenore:

Codice di formulazione:

Principio attivo:

Glifosato

30.4 % 360 g/l

[pari a 41% di Glifosato - isopropile sale di

ammonio (486 g/l)]

SL concentrato solubile in

acqua

Applicazioni

A

Coltura

Agente

patogeno/Efficacia

Dosaggio

Restrizioni

B Mora

Dicotiledoni annuali

(malerbe)

Gramigna

Monocotiledoni annuali

(malerbe).

Dose: 2 - 3 l/ha

1, 2, 3, 4

B Mora

Dicotiledoni pluriennali

(malerbe)

Monocotiledoni perenni

(malerbe)

Dose: 4 - 10 l/ha

1, 2, 3, 4

Frutta a granelli

Frutta a nocciolo

Dicotiledoni annuali

(malerbe)

Gramigna

Monocotiledoni annuali

(malerbe).

Dose: 2 - 3 l/ha

1, 2, 3, 4

Frutta a granelli

Frutta a nocciolo

Dicotiledoni pluriennali

(malerbe)

Monocotiledoni perenni

(malerbe)

Dose: 4 - 10 l/ha

1, 2, 3, 4

W Vite in produzione

Dicotiledoni annuali

(malerbe)

Gramigna

Monocotiledoni annuali

(malerbe).

Dose: 2 - 3 l/ha

1, 2, 3, 4, 5

A

Coltura

Agente

patogeno/Efficacia

Dosaggio

Restrizioni

W Vite in produzione

Dicotiledoni pluriennali

(malerbe)

Monocotiledoni perenni

(malerbe)

Dose: 4 - 10 l/ha

1, 2, 3, 4, 5

G Maggese

Dicotiledoni annuali

(malerbe)

Gramigna

Monocotiledoni annuali

(malerbe).

Dose: 2 - 3 l/ha

1, 2, 3, 5

G Maggese

Dicotiledoni pluriennali

(malerbe)

Monocotiledoni perenni

(malerbe)

Dose: 4 - 10 l/ha

1, 2, 3, 5

Maggese

Semine a lattiera

Semine dopo la

fresatura

Dicotiledoni annuali

(malerbe)

Gramigna

Monocotiledoni annuali

(malerbe).

Dose: 2 - 3 l/ha

1, 2, 3, 5

Maggese

Semine a lattiera

Semine dopo la

fresatura

Dicotiledoni pluriennali

(malerbe)

Monocotiledoni perenni

(malerbe)

Dose: 4 - 10 l/ha

1, 2, 3, 5

Prati e pascoli

Dicotiledoni (malerbe)

Monocotiledoni

(malerbe)

Dose: 4 - 10 l/ha

Applicazione: Trattamento su tutta la

superficie prima della risemina.

1, 2, 3, 5

Prati e pascoli

Dicotiledoni (malerbe)

Monocotiledoni

(malerbe)

Concentrazione: 5 - 10 %

Applicazione: Trattamento pianta per

pianta con vaporizzatori manuali.

1, 2, 3, 6

Prati e pascoli

Dicotiledoni (malerbe)

Monocotiledoni

(malerbe)

Concentrazione: 0.5 - 1.5 %

Applicazione: Trattamento pianta per

pianta con vaporizzatore a zaino.

1, 2, 3, 6

Arbusti

Boschetti (al di fuori

del bosco)

Dicotiledoni annuali

(malerbe)

Gramigna

Monocotiledoni annuali

(malerbe).

Dose: 2 - 3 l/ha

1, 2, 3, 4

Arbusti

Boschetti (al di fuori

del bosco)

Dicotiledoni pluriennali

(malerbe)

Monocotiledoni perenni

(malerbe)

Dose: 4 - 10 l/ha

1, 2, 3, 4

Piante [annuale e

Dicotiledoni annuali

Dose: 2 - 3 l/ha

1, 2, 3, 5

A

Coltura

Agente

patogeno/Efficacia

Dosaggio

Restrizioni

biennale]

(malerbe)

Gramigna

Monocotiledoni annuali

(malerbe).

Piante [annuale e

biennale]

Dicotiledoni pluriennali

(malerbe)

Monocotiledoni perenni

(malerbe)

Dose: 4 - 10 l/ha

1, 2, 3, 5

Superficie coltiva

aperta

Convolvulaceae

Gramigna

Romice comune

Stoppione

Concentrazione: 5 - 10 %

Applicazione: Con vaporizzatori manuali

(senza vaporizzatore a zaino).

1, 2, 7

Ö Superficie inerbita

Romice comune

Stoppione

Concentrazione: 5 - 10 %

Applicazione: Con vaporizzatori manuali

(senza vaporizzatore a zaino).

1, 2, 6, 7

Restrizioni e osservazioni:

L'utente deve essere accuratamente informato sui rischi di danni. Occorre indicare le possibilità di

prevenzione.

Non devono esserci precipitazioni durante almeno 6 ore dopo il trattamento.

Per il trattamento di focolai di malerbe/pianta per pianta, la concentrazione della poltiglia per

irrorazione è indicata in funzione delle specie di malerbe.

Trattamento al più tardi entro fine agosto. Non possono essere trattate le parti vegetali verdi e le

vigne con sistemi di potatura corta (gobelet, cordoni permanenti, eccetera).

Trattamento al più tardi fino a 2 settimane prima della semina o della piantagione.

Pascolo o sfalcio (foraggio fresco o conservato) al più presto 3 settimane dopo il trattamento.

Eccezione: per gli animali non in lattazione il termine di attesa è di 2 settimane.

Per il trattamento pianta per pianta secondo l'ordinanza sui pagamenti diretti (OPD).

Caratterizzazione di pericolo:

Tenere fuori dalla portata dei bambini.

EUH 401 Per evitare rischi per la salute umana e per l'ambiente, seguire le istruzioni per l'uso.

H411 Tossico per gli organismi acquatici con effetti di lunga durata.

SP 1 Non contaminare l'acqua con il prodotto o il suo imballaggio.

Simboli e indicazioni di pericolo:

Identificatore chiave

GHS09

Simbolo

Indicazione di pericolo Pericoloso per l'ambiente acquatico

In caso di dubbio valgono soltanto i documenti originali dell'omologazione. La menzione di un prodotto,

principio attivo o di una ditta non rappresenta alcuna raccomandazione.

19-1-2019

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Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

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Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety evaluation of the food enzyme glucose isomerase from Streptomyces murinus (strain NZYM‐GA)

Safety evaluation of the food enzyme glucose isomerase from Streptomyces murinus (strain NZYM‐GA)

Published on: Fri, 11 Jan 2019 The food enzyme is a glucose isomerase (d‐xylose aldose‐ketose‐isomerase; EC 5.3.1.5) produced with a non‐genetically modified Streptomyces murinus strain NZYM‐GA by Novozymes A/S. The glucose isomerase is intended only to be used in an immobilised form in glucose isomerisation for the production of high fructose syrups. Residual amounts of total organic solids are removed by the purification steps applied during the production of high fructose syrups using the immobilised...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

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Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

21-12-2018

National Research Programme for Environmental and Occupational Health:  43 projects selected and €7.4 million mobilised  for the 2018 calls for projects

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France - Agence Nationale du Médicament Vétérinaire

17-12-2018

Vijf jaar NIX brengt normverandering roken en drinken op gang

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Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

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Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

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

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

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Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

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Europe - EFSA - European Food Safety Authority Publications

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

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Europe - EFSA - European Food Safety Authority Publications

29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives

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France - Agence Nationale du Médicament Vétérinaire

28-11-2018

ANSES provides access to the data from its study on dietary exposure of children under three years of age to chemicals

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France - Agence Nationale du Médicament Vétérinaire

22-11-2018

National Research Programme on Environmental and Occupational Health:  calls for research projects issued for 2019

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France - Agence Nationale du Médicament Vétérinaire

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 Experimental Animals

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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

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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

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

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Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Three research projects to increase our knowledge of medicinal cannabis

Three research projects to increase our knowledge of medicinal cannabis

Three projects have just been granted funds to give us more knowledge about the efficacy of medicinal cannabis. A total of DKK 5 million have been distributed of the funds that were appropriated by the negotiating parliamentary parties under the special funds agreement 2018-2021 to accumulate scientific knowledge of medicinal cannabis.

Danish Medicines Agency

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 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 HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

27-9-2018

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. ...

FDA - U.S. Food and Drug Administration

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

FDA has awarded five grants totaling $650,000 to provide funding for studies to support the approval or conditional approval of three different products, including a cancer drug for dogs.

FDA - U.S. Food and Drug Administration

5-6-2018

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

FDA - U.S. Food and Drug Administration

11-5-2018

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

FDA - U.S. Food and Drug Administration

29-11-2018


Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Europe - EMA - European Medicines Agency

22-7-2018

We'll integrate #FDA’s premarket and post-market activities through a reorganization in our medical device centers, creating a broader and deeper view of device safety, effectiveness and quality across the total product life cycle. Patient Safety is at th

We'll integrate #FDA’s premarket and post-market activities through a reorganization in our medical device centers, creating a broader and deeper view of device safety, effectiveness and quality across the total product life cycle. Patient Safety is at th

We'll integrate #FDA’s premarket and post-market activities through a reorganization in our medical device centers, creating a broader and deeper view of device safety, effectiveness and quality across the total product life cycle. Patient Safety is at the center of these efforts pic.twitter.com/msK4BH9BPQ

FDA - U.S. Food and Drug Administration

22-7-2018

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each area pic.twitter.com/aDwVxKGjyA

FDA - U.S. Food and Drug Administration

25-6-2018

Rapporto nazionale sull’uso dei farmaci in Italia 2017

Rapporto nazionale sull’uso dei farmaci in Italia 2017

È stato presentato oggi in AIFA il Rapporto Nazionale sull’uso dei Farmaci, che propone anche quest’anno una descrizione dettagliata dell’assistenza farmaceutica in Italia, fotografando un incremento rispetto al 2016 pari al 4,3% per i consumi e all’1,2% per la spesa farmaceutica nazionale totale.

Italia - AIFA - Agenzia Italiana del Farmaco