Cement

Main information

  • Trade name:
  • Cement, dental, glass ionomer
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cement, dental, glass ionomer
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217460
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217460

SDI Ltd - Cement, dental, glass ionomer

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

SDI Ltd

Postal Address

PO Box 314,BAYSWATER, VIC, 3153

Australia

ARTG Start Date

19/11/2013

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

SDI Ltd

3-15 Brunsdon Street

BAYSWATER, VIC, 3153

Australia

Products

1. Cement, dental, glass ionomer

Product Type

Single Device Product

Effective date

19/11/2013

GMDN

16704 Cement, dental, glass ionomer

Intended purpose

Cementation of metal free or porcelain fused to metal inlays, onlays, bridges and crowns. Cementation of

stainless steel crowns. Cementation of posts and screws. Attachment of metal orthodontic bands. Base or

liner.

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 02:18:05 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

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Enforcement Report for the Week of March 20, 2019

Enforcement Report for the Week of March 20, 2019

Recently Updated Records for the Week of March 20, 2019 Last Modified Date: Monday, March 18, 2019

FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Enforcement Report for the Week of March 13, 2019

Enforcement Report for the Week of March 13, 2019

Recently Updated Records for the Week of March 13, 2019 Last Modified Date: Tuesday, March 12, 2019

FDA - U.S. Food and Drug Administration

6-3-2019

Enforcement Report for the Week of March 06, 2019

Enforcement Report for the Week of March 06, 2019

Recently Updated Records for the Week of March 06, 2019 Last Modified Date: Friday, March 01, 2019

FDA - U.S. Food and Drug Administration

27-2-2019

Enforcement Report for the Week of February 27, 2019

Enforcement Report for the Week of February 27, 2019

Recently Updated Records for the Week of February 27, 2019 Last Modified Date: Wednesday, February 20, 2019

FDA - U.S. Food and Drug Administration

22-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

FDA - U.S. Food and Drug Administration

22-2-2019

Enforcement Report for the Week of February 20, 2019

Enforcement Report for the Week of February 20, 2019

Recently Updated Records for the Week of February 20, 2019 Last Modified Date: Friday, February 22, 2019

FDA - U.S. Food and Drug Administration

22-2-2019

Enforcement Report for the Week of January 23, 2019

Enforcement Report for the Week of January 23, 2019

Recently Updated Records for the Week of January 23, 2019 Last Modified Date: Friday, February 22, 2019

FDA - U.S. Food and Drug Administration

21-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes

FDA releases the second of two draft guidances aimed at supporting the development of novel nicotine replacement therapies.

FDA - U.S. Food and Drug Administration

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-2-2019

Enforcement Report for the Week of February 13, 2019

Enforcement Report for the Week of February 13, 2019

Recently Updated Records for the Week of February 13, 2019 Last Modified Date: Monday, February 11, 2019

FDA - U.S. Food and Drug Administration

12-2-2019

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

FDA - U.S. Food and Drug Administration

7-2-2019

FDA pursues order barring specific retailers from selling tobacco products as part of its continuing efforts to target youth tobacco use

FDA pursues order barring specific retailers from selling tobacco products as part of its continuing efforts to target youth tobacco use

FDA has initiated enforcement action against certain retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.

FDA - U.S. Food and Drug Administration

6-2-2019

Enforcement Report for the Week of February 06, 2019

Enforcement Report for the Week of February 06, 2019

Recently Updated Records for the Week of February 06, 2019 Last Modified Date: Tuesday, February 05, 2019

FDA - U.S. Food and Drug Administration

5-2-2019

March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

2-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for imazamox

Evaluation of confirmatory data following the Article 12 MRL review for imazamox

Published on: Fri, 01 Feb 2019 The applicant BASF SE submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for imazamox in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, the applicant submitted new residue trials on rice. Since the number of trials was not sufficient, the data gap was considered only partially addressed. The remaining dat...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Modification of the existing maximum residue levels for sulfoxaflor in various crops

Modification of the existing maximum residue levels for sulfoxaflor in various crops

Published on: Thu, 31 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in various crops, including limes imported from Australia. The data submitted in support of the request were found to be sufficient to derive MRL proposals for limes, cauliflowers, Brussels sprouts, kales, spinaches and similar ...

Europe - EFSA - European Food Safety Authority EFSA Journal

30-1-2019

Enforcement Report for the Week of January 30, 2019

Enforcement Report for the Week of January 30, 2019

Recently Updated Records for the Week of January 30, 2019 Last Modified Date: Monday, January 28, 2019

FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Instinct Best Sexual Enjoyment contains hidden drug ingredient

Public Notification: Instinct Best Sexual Enjoyment contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Instinct Best Sexual Enjoyment, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Red Stallion Extra Strong contains hidden drug ingredient

Public Notification: Red Stallion Extra Strong contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Red Stallion Extra Strong, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Yong Gang contains hidden drug ingredients

Public Notification: Yong Gang contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Yong Gang, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Golden Ant contains hidden drug ingredient

Public Notification: Golden Ant contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Golden Ant, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Natural V=GRA contains hidden drug ingredients

Public Notification: Natural V=GRA contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Natural V=GRA, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-1-2019

Public Notification: Nectar Del Amor contains hidden drug ingredient

Public Notification: Nectar Del Amor contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Nectar Del Amor, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-1-2019

Enforcement Report for the Week of January 09, 2019

Enforcement Report for the Week of January 09, 2019

Recently Updated Records for the Week of January 09, 2019 Last Modified Date: Monday, January 21, 2019

FDA - U.S. Food and Drug Administration

16-1-2019

Enforcement Report for the Week of January 16, 2019

Enforcement Report for the Week of January 16, 2019

Recently Updated Records for the Week of January 16, 2019 Last Modified Date: Tuesday, January 15, 2019

FDA - U.S. Food and Drug Administration

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Public Notification: The Silver Bullet contains hidden drug ingredients

Public Notification: The Silver Bullet contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use The Silver Bullet, a product promoted for sexual enhancement and sold on various websites, including www.ebay.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-1-2019

Enforcement Report for the Week of January 02, 2019

Enforcement Report for the Week of January 02, 2019

Recently Updated Records for the Week of January 02, 2019 Last Modified Date: Monday, January 07, 2019

FDA - U.S. Food and Drug Administration

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-12-2018

Enforcement Report for the Week of December 26, 2018

Enforcement Report for the Week of December 26, 2018

Recently Updated Records for the Week of December 26, 2018 Last Modified Date: Friday, December 21, 2018

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.

FDA - U.S. Food and Drug Administration

19-12-2018

Enforcement Report for the Week of December 19, 2018

Enforcement Report for the Week of December 19, 2018

Recently Updated Records for the Week of December 19, 2018 Last Modified Date: Monday, December 17, 2018

FDA - U.S. Food and Drug Administration

12-12-2018

Enforcement Report for the Week of December 12, 2018

Enforcement Report for the Week of December 12, 2018

Recently Updated Records for the Week of December 12, 2018 Last Modified Date: Wednesday, December 12, 2018

FDA - U.S. Food and Drug Administration

12-12-2018

White-Rodgers recalls First-Generation Emerson branded Sensi Wi-Fi Thermostats

White-Rodgers recalls First-Generation Emerson branded Sensi Wi-Fi Thermostats

The thermostat can be damaged by household line voltage (120 volts or 240 volts) during service or replacement of a heating or cooling system, posing a fire hazard.

Health Canada

12-12-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in France and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in France and EFSA – Final report

Published on: Tue, 11 Dec 2018 The main goal of the Framework Partnership Agreement project is to put in place a relevant organisation in order to improve gathering, checking, storage and providing of data from national monitoring programs to EFSA. By accepting to participate in the pilot project, France has committed to implement several enhancement actions on the overall system of data collection and submission. This report describes the results of the implementations of these measures and presents th...

Europe - EFSA - European Food Safety Authority Publications

10-12-2018

Public Notification: On Demand contains hidden drug ingredient

Public Notification: On Demand contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use On Demand, a product promoted and sold for sexual enhancement on various websites, including www.goodlifeondemand.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

5-12-2018

Enforcement Report for the Week of December 05, 2018

Enforcement Report for the Week of December 05, 2018

Recently Updated Records for the Week of December 05, 2018 Last Modified Date: Friday, November 30, 2018

FDA - U.S. Food and Drug Administration

3-12-2018

January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

3-12-2018

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

30-11-2018

Public Notification: MOB Candy contains hidden drug ingredients

Public Notification: MOB Candy contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use MOB Candy, a product promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA - U.S. Food and Drug Administration

30-11-2018

Public Notification: Willy Go Wild contains hidden drug ingredients

Public Notification: Willy Go Wild contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Willy Go Wild, a product promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA - U.S. Food and Drug Administration

28-11-2018

Enforcement Report for the Week of November 28, 2018

Enforcement Report for the Week of November 28, 2018

Recently Updated Records for the Week of November 28, 2018 Last Modified Date: Tuesday, November 27, 2018

FDA - U.S. Food and Drug Administration

27-11-2018

FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health

FDA - U.S. Food and Drug Administration

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

21-11-2018

Public Notification: America Treasure contains hidden drug ingredient

Public Notification: America Treasure contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use America Treasure, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

21-11-2018

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Enforcement Report for the Week of November 14, 2018

Enforcement Report for the Week of November 14, 2018

Recently Updated Records for the Week of November 14, 2018 Last Modified Date: Tuesday, November 13, 2018

FDA - U.S. Food and Drug Administration

4-12-2018


Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Europe - EMA - European Medicines Agency

28-11-2018

Listed medicine compliance rating scheme

Listed medicine compliance rating scheme

We have implemented a Compliance Rating Scheme for listed medicines as part of ongoing enhancements to our post-market compliance monitoring program

Therapeutic Goods Administration - Australia