Skin

Main information

  • Trade name:
  • Skin moisturizing/barrier dressing
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Skin moisturizing/barrier dressing
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218161
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218161

3M Australia Pty Ltd - Skin moisturizing/barrier dressing

ARTG entry for

Medical Device Included Class 1

Sponsor

3M Australia Pty Ltd

Postal Address

Locked Bag 19,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

5/12/2013

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

3M Health Care Group

3M Center

St Paul, MN, 55144-1000

United States Of America

Products

1. Skin moisturizing/barrier dressing

Product Type

Single Device Product

Effective date

5/12/2013

GMDN

46206 Skin moisturizing/barrier dressing

Intended purpose

To be used as a moisturiser and/or a protective barrier on dry, cracked, or flaking skin.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 11:36:12 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

22-3-2019

Safety and efficacy of l‐tryptophan produced with Escherichia coli CGMCC 11674 for all animal species

Safety and efficacy of l‐tryptophan produced with Escherichia coli CGMCC 11674 for all animal species

Published on: Thu, 21 Mar 2019 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 l‐tryptophan produced by fermentation with Escherichia coli CGMCC 11674 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain did not raise safety concerns. The FEEDAP Panel cannot conclude on the safety of l‐tryptophan produced ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Lumpy skin disease III. Data collection and analysis

Lumpy skin disease III. Data collection and analysis

Published on: Thu, 21 Mar 2019 In 2018, no lumpy skin disease (LSD) outbreaks were reported in the Balkan region, after the decline reported in 2017 (385) compared to 2016 (7,483). This confirms the effectiveness of the vaccination campaign based on the LSD homologous vaccine strain which continued throughout 2018 with over 2.5 million animals vaccinated, keeping the mean vaccination coverage above 70%. In 2018, LSD outbreaks were reported in Russia, Turkey and Georgia. In Russia, the LSD epidemics expa...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

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

20-3-2019

Assessment of the application for renewal of authorisation of Bonvital® (Enterococcus faecium DSM 7134) as a feed additive for weaned piglets and pigs for fattening

Assessment of the application for renewal of authorisation of Bonvital® (Enterococcus faecium DSM 7134) as a feed additive for weaned piglets and pigs for fattening

Published on: Tue, 19 Mar 2019 Bonvital® is the trade name for a feed additive based on Enterococcus faecium DSM 7134 currently authorised for use in piglets, pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. This opinion concerns the renewal of the authorisation of Bonvital® as a zootechnical additive for weaned piglets and pigs for fattening. The applicant is proposing to increase the minimum and maximum inclusion level of the additive in feed for ...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

Published on: Tue, 12 Mar 2019 In 2017, the EFSA Panel on Additive and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Probion Forte®(Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) as a feed additive for chickens for fattening. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment provided that the identity of the strains is established and the lack ...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019

Data sources on animal diseases:Country Card of Denmark

Data sources on animal diseases:Country Card of Denmark

Published on: Thu, 07 Mar 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019

Safety and efficacy of Actisaf® Sc47 (Saccharomyces cerevisiae CNCM I‐4407) as a feed additive for cattle for fattening, dairy cows, weaned piglets and sows

Safety and efficacy of Actisaf® Sc47 (Saccharomyces cerevisiae CNCM I‐4407) as a feed additive for cattle for fattening, dairy cows, weaned piglets and sows

Published on: Thu, 07 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 Actisaf® Sc47 for dairy cows, cattle for fattening, weaned piglets and sows when used as a zootechnical additive. Actisaf® Sc47 consists of viable cells of a strain Saccharomyces cerevisiae and is marketed in three formulations. The FEEDAP Panel considers that the three ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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 Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of l‐valine produced using Corynebacterium glutamicum CGMCC 11675 for all animal species

Safety and efficacy of l‐valine produced using Corynebacterium glutamicum CGMCC 11675 for all animal species

Published on: Mon, 04 Mar 2019 The product subject of this assessment is l‐valine produced by fermentation with a strain of Corynebacterium glutamicum (CGMCC 11675). It is intended to be used in feed and water for drinking for all animal species and categories. Owing to the uncertainties regarding the possible genetic modification of the original production strain, the FEEDAP Panel cannot conclude on the safety of the additive l‐valine produced with C. glutamicum CGMCC 11675 for the target species, the ...

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 l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species

Published on: Thu, 28 Feb 2019 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 l‐tryptophan produced by fermentation with a genetically modified strain of Escherichia coli CGMCC 7.248 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli CGMCC 7.248 and its recombinant DNA were not detected in the f...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species

Safety and efficacy of l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species

Published on: Thu, 28 Feb 2019 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 l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ when used as a nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l‐threonine produced by fermentation with a ■■■■■ strain of C. glutamicum (■■■■■). l‐Threo...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

19-2-2019

Data sources on animal diseases: Country Card of Sweden

Data sources on animal diseases: Country Card of Sweden

Published on: Mon, 18 Feb 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Slovakia

Data sources on animal diseases: Country Card of Slovakia

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspo...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Finland

Data sources on animal diseases: Country Card of Finland

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Czech Republic

Data sources on animal diseases: Country Card of Czech Republic

Published on: Mon, 18 Feb 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Italy

Data sources on animal diseases: Country Card of Italy

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspon...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-2-2019

Medline Canada, Corp. recalls certain lots of Remedy Phytoplex Nourishing Skin Cream

Medline Canada, Corp. recalls certain lots of Remedy Phytoplex Nourishing Skin Cream

The affected products are being recalled due to the presence of certain species of mould, Penicillium chrysogenum and Penicillium flavigenum. The affected products are not likely to cause an adverse health consequence in healthy individuals, however, may pose a risk to people with weakened immune systems.

Health Canada

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

1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

22-1-2019

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

Published on: Mon, 21 Jan 2019 The European Commission is routinely asking EFSA for scientific and technical support in the epidemiological analysis of animal disease outbreaks (i.e. African swine fever, lumpy skin disease and avian influenza) and to report or assess surveillance data (i.e. Echinococcus multilocularis and avian influenza). For this purpose, EFSA has over the last years carried out several data collections and gathered specific information on outbreaks, surveillance activities and concer...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Data sources on animal diseases: Country Card of Ireland

Data sources on animal diseases: Country Card of Ireland

Published on: Mon, 21 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 ;project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Poland

Data sources on animal diseases: Country Card of Poland

Published on: Fri, 18 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Belgium

Data sources on animal diseases: Country Card of Belgium

Published on: Fri, 18 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Portugal

Data sources on animal diseases: Country Card of Portugal

Published on: Thu, 17 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Lithuania

Data sources on animal diseases: Country Card of Lithuania

Published on: Thu, 17 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Spain

Data sources on animal diseases: Country Card of Spain

Published on: Thu, 17 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Latvia

Data sources on animal diseases: Country Card of Latvia

Published on: Thu, 17 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Greece

Data sources on animal diseases: Country Card of Greece

Published on: Wed, 16 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Austria

Data sources on animal diseases: Country Card of Austria

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA 's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresp...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Cyprus

Data sources on animal diseases: Country Card of Cyprus

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Bulgaria

Data sources on animal diseases: Country Card of Bulgaria

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State, is one of the activities of EFSA 's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspo...

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

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

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

Safety and efficacy of Lactobacillus reuteri NBF‐2 (DSM 32264) as a feed additive for cats

Safety and efficacy of Lactobacillus reuteri NBF‐2 (DSM 32264) as a feed additive for cats

Published on: Fri, 11 Jan 2019 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 Lactobacillus reuteri NBF‐2 when used in feed for cats at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32264. This species is considered by EFSA to be suitable for the qualified presum...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs

Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs

Published on: Fri, 11 Jan 2019 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 Lactobacillus reuteri NBF‐1 when used in feed for dogs at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32203. This species is considered by the European Food Safety Authority to be sui...

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

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

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

12-1-2019

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Published on: Fri, 11 Jan 2019 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 rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys f...

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

Data sources on animal diseases: Methodology on mapping the data sources on animal diseases in European Union Member States

Data sources on animal diseases: Methodology on mapping the data sources on animal diseases in European Union Member States

Published on: Wed, 19 Dec 2018 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which Animal Health and Plant Health Unit is currently working): African swine fever, avian influenza and lumpy skin...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-12-2018

Preparation and handling of slime: the health authorities call for continued vigilance

Preparation and handling of slime: the health authorities call for continued vigilance

ANSES, the DGS and the DGCCRF are reiterating the risks associated with preparing and handling "slime", a sticky and elastic putty for kneading that is very popular with children and adolescents. The repeated and prolonged handling of this putty can cause skin irritations and allergies that are sometimes severe. From January to May 2018, the number of reported cases was double the number for all of 2017.

France - Agence Nationale du Médicament Vétérinaire

26-11-2018

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap.

FDA - U.S. Food and Drug Administration

24-11-2018

Lumpy skin disease: Workshop on risk assessment and data collection for epidemiology, control and surveillance

Lumpy skin disease: Workshop on risk assessment and data collection for epidemiology, control and surveillance

Published on: Fri, 23 Nov 2018 Abstract The epidemics of lumpy skin disease in EU has been controlled mainly thanks to the coordinated control measures taken in the Balkan region, based above all on regional vaccination campaign. Since before the epidemics EFSA has been performing risk assessment on LSD to support the decision making process both for EC and also for the national authorities. Periodical meetings with representatives from affected and at risk countries have been organised by EFSA in order...

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

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

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

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

30-10-2018

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

Danish Medicines Agency

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

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

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

6-3-2019

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Europe - EMA - European Medicines Agency

26-11-2018

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do:  https://go.usa.gov/xPHtk   #FDA #MedicalDevice

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration