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FSANZ Food Recalls for March 2016 at Unusually High Levels

Food Standards Australia New Zealand have recalled twelve food products this month, an unusally high number and too many for us to list here individually. The reasons for the recalls are due to a range of issues including undeclared allergens, microbial contamination, bio-toxins present, and presence of foreign matter. For a full list of recalled foods and reasons for recall, go to: March 2016 Food recalls

FSANZ Revises Food Standards Code

Food Standards Australia New Zealand (FSANZ) today notified all stakeholders that a revised version of the Food Standards Code has now come into effect. There is no transition period between the old and the new version of the Code. A summary of the changes to the code can be read here: Food Code changes

FSANZ Reviews Standard 2.9.1 – Infant Formula Products

FSANZ is reviewing Standard 2.9.1 – Infant Formula Products and other standards in the Code that regulate infant formula. The aim of this work is to ensure that the regulation of infant formula is clear and reflects the latest scientific evidence. FSANZ is also considering harmonising the Code with international regulations. Source: Infant formula

FSANZ Application A1128 – Food Derived From Reduced Acrylamide Potential & Browning Potato Line E12

The purpose of the Application is to seek approval for food derived from a genetically modified potato line, E12 which has reduced acrylamide potential and reduced browning (black spot).  Source: GM Potato line

FSANZ Application A1120 – Agarose Ion Exchange Resin as a Processing Aid for Lactoferrin Production

The purpose of this Application is to seek permission for the use of agarose ion exchange resin as a processing aid in the production of high purity lactoferrin from bovine milk and milk-related products. (Submissions close 29 March 2016)  Source: Agarose resin

FSANZ Proposal P1031 – Allergen Labelling Exemptions

The purpose of this Proposal is to allow for specific exemptions from allergen declarations for glucose syrups from wheat starch, fully refined soy oil, soy derivatives (tocopherols and phytosterols), and distilled alcohol from wheat or whey.  Source: Allergen labelling

FSANZ Proposal M1011 – Maximum Residue Limits

The purpose of the Proposal is to consider varying certain maximum residue limits for residues of agricultural and veterinary chemicals that may occur in food.  Source: MRL in foods

TGA Issues Statement Regarding GMP Clearance Process for MRA Countries

The Therapeutic Goods Administration receives a large number of Good Manufacturing Practice (GMP) Clearance applications which use a GMP Certificate issued by a Mutual Recognition Agreement (MRA) partner for a manufacturing site located in the same country (MRA GMP Clearance applications). Australian sponsors of medicines manufactured overseas have a responsibility to ensure that all required documents are submitted with a GMP Clearance application or this may result in the clearance not being issued. TGA receives approximately 2000 MRA applications per year and is no longer prepared to chase up applicants with missing paperwork.  Source: Missing MRA docs

TGA Reminder to Cancel Unnecessary ARTG Entries by 30 June 2016

Sponsors are reminded that if they are no longer supplying a product they can cancel their entries from the ARTG before 1 July 2016 if they do not wish to incur an annual charge for those entries in the 2016-17 financial year.  Source: ARTG 2016/17

TGA Lists Complementary Medicines Cancelled from the ARTG

This link provides detailed information on all of the CM products that have been removed from the Australian Register of Therapeutic Goods and why they have failed to comply with the regulations. One company in particular seems to have had their whole product range cancelled due to steps in manufacture not done under GMP.  Source: ARTG cancellations

TGA Recalls Shen Neng Ching Fei Yi Hou Pien (AustL 57184)

SHEN NENG CHING FEI YI HOU PIEN (AUSTL 57184) was found by Therapeutic Goods Administration Laboratories to be contaminated with Paracetamol. The content of paracetamol was estimated by LC/MS to be 9 mcg/g (9 ppm). This is below the SUSMP threshold limit of 10 ppm (10 mg/kg) for scheduling of paracetamol. However, paracetamol is not declared in the ARTG entry for AUSTL 57184 and is not approved for use in listed medicines.  Source: Paracetamol contamination

TGA Recalls Betamin 100 mg Vitamin B1 tablets (AustR 27460)

Consumers and health professionals are advised that Sanofi, in consultation with the TGA, is recalling one batch of Betamin tablets AustR 27460 (thiamine hydrochloride 100 mg) due to the potential that some bottles may contain at least one Plavix/Iscover (clopidogrel 75 mg) tablet. Thiamine hydrochloride is a type of vitamin B and is used to treat vitamin deficiency. Clopidogrel is used to prevent blood clots in patients with certain heart and blood vessel disorders.  Source: Betamin recall

Department of Agriculture Notice IFN 03-16 - Producer Must be Declared for all Imported Food

The purpose of this notice is to advise that scheduled changes to the Department of Immigration and Border Protection (DIBP) Integrated Cargo System (ICS) will allow licensed customs brokers to create AQIS Producer Codes (producer). This notice also advises of the implementation date for a producer to be declared for all imported food.  Source: Food notice

China Announces Regulations for Health Foods

The China Food & Drug Authority (CFDA) published the formal “Administrative Measures on Health Food Registration and Filing”, which will replace the “Administrative Measure on Health Food Registration (Trial) (Order No.19)”, which comes into force on 1 July, 2016. Once the new Administrative Measures are implemented, there will be two kinds of policy (registration and filing) for health food produced or marketed in China.  Source: CIRS China Health Foods

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Business & Marketing News:

Focus on Trust is Just What the Natural Products Industry Needs

Martha Rogers was keynote speaker at the recent Natural Products Expo West and spoke on the topic of trust and trustability. Being trustworthy means living up to your word but trustability is about being capable of being trusted. Because of the way social media has connected everyone to everything, customers have a whole new level of expectation regarding how companies relate to them. So that’s the paradigm shift: having your business strategy be customer-centric (all about them) instead of product-centric (trying to sell more stuff to them). Where does your business … ?

Source: Risa Schullman, NewHope Network Focus on trust

Quote for this month: “Trust is built with consistency”. Lincoln Chafee