Advice summary application for registration of a chemical product



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ADVICE SUMMARY

APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT


Product name: QUANTUM BLUE 5 G

Applicant: ROAL OY

Product number: 68771

Application number: 59049

Purpose of Application and Description of Use: Registration of a 5000 FTU/g 6-phytase enzyme feed additive product for improvement of plant phosphorus digestibility in pigs and poultry.

Active Constituent(s):



Regulatory Decision:


To grant the application subject to the following conditions:

Standard Conditions of Registration/Approval


  1. Containers must meet AgVet Code Regulation 18

  2. Product must not be supplied without meeting GMP Requirements

  3. Label must contain an Expiry Date and Batch Number

For full conditions, refer to Standard Conditions for Applications on the APVMA website.

Non-Standard Conditions of Registration/Approval


none

ADVICE

External Chemistry Reviewer


The external reviewer has evaluated the data presented by the applicant in support of chemistry and is satisfied that the chemistry requirements of the AgVet Code have been met.

Data relied on to provide the advice

Data No

Data Source*

Author(s)

Title

Date

Data Type

Data Sub-type

Authorising Party

Inherited Application No.

77055

S

International Standard - ISO

Microbiology - General guidance for the enumeration of coliforms - Colony count technique

1 March 1991

Chemistry and Manufacture

Active Constituent, Analytical Methods

Public




77060

S

City of Helsinki Environment Centre

Escherichia coli, detection

14 July1999

Chemistry and Manufacture

Active Constituent, Analytical Methods

Applicant




77059

S

European Standard

Water Quality - Application of inductively coupled plasma mass spectrometry (ICP-MS) - Part 2: Determination of 62 elements

October 2004

Chemistry and Manufacture

Active Constituent, Analytical Methods

Public




77058

S

International Standard - ISO

Microbiology - General guidance for the enumeration of micro-organisms - Colony count technique at 30 degrees C

1 March1991

Chemistry and Manufacture

Active Constituent, Analytical Methods

Public




77052

S

Dr Andreas Dreusch, MicroMol Gmbh, Karlruhe, Germany

Establishment and validation of a test syetm and testing of lots of phytase enzyme lots for contaminating DNA-traces. Report Number: B0279ABZ2959_0001

21 December 2011

Chemistry and Manufacture

Active Constituent, Analytical Methods

Applicant




77053

S

Terhi Puranen, Roal

Analysis of the genome of RF8694 (E. coli QPT2 phytase production strain) by Southern blot.

23 March 2012

Chemistry and Manufacture

Active Constituent, Analytical Methods

Applicant




77054

S

Roal Oy

Assay of phytase activity (ay pH 4.5 and 60 degrees C by inorganic phoasphate release)

8 February 2012

Chemistry and Manufacture

Active Constituent, Analytical Methods

Applicant




77073

S

International Standard - ISO

Microbiology - General guidance on methods for the detection of Salmonella

1 September 1993

Chemistry and Manufacture

Active Constituent, Analytical Methods

Public




77056

S

Roal Oy

Assay of the phytase activity (at pH 5.5 by inorganic phosphate release)

17 January 2012

Chemistry and Manufacture

Active Constituent, Analytical Methods

Applicant




77051

S

The thirty-ninth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Toxicological evaluation of certain food additives and naturally occurring toxicants

1993

Chemistry and Manufacture

Active Constituent, Other Information

Public




77050

S

H. Nevalainen, P. Suominen & K. Taimisto

Minireview On the safety of Trichoderma reesei

1994

Chemistry and Manufacture

Active Constituent, Other Information

Public




77049

S

U. Konietzny & R. Greiner

Molecular and catalytic properties of phytate-degrading enzymes (phytases)

2002

Chemistry and Manufacture

Active Constituent, Other Information

Public




77048

S

J. Dassa, C. Marck & P.L. Boquet

The complete nucleotide Sequence of the Escherichia coli Gene appA reveals significant homology between pH 2.5 acid phosphate and glucose 1-phosphate

September 1990

Chemistry and Manufacture

Active Constituent, Other Information

Public




77061

S

AB Enzymes

In-house method validation for phytase activity

March 2012

Chemistry and Manufacture

Product, Analytical Methods

Applicant




77057

S

Powtec Maschinen und Engineering GmbH, Remscheid, Germany

Operating instructions to determination of apparent density according ISO 697 with powtec apparatus for determination of apparent density SMG 697

29 October 1998

Chemistry and Manufacture

Product, Analytical Methods

Public




77069

S

Roal Oy

Determination of yeasts and molds, Sabourad-Glucose medium

8 November 2002

Chemistry and Manufacture

Product, Analytical Methods

Applicant




77068

S

FOA/WHO/JECFA 1990

Specifications for identity and purity of certain food additives

1990

Chemistry and Manufacture

Product, Analytical Methods

Public




77067

S

Institut Kuhlman GmbH, Germany

Mycotoxins (ochratoxin A, zearalenone, sterigmatocystin and T2-toxin) by LC/MS

23 August 2007

Chemistry and Manufacture

Product, Analytical Methods

Applicant




77066

S

-

Microwave assisted acid digestion of sediments, sludges, soils and oils

January 1998

Chemistry and Manufacture

Product, Analytical Methods

Applicant




77085

S

Roal Ltd

Determination of particle size distribution. LIMS ID 2011-244-1-6

30 December 2011

Chemistry and Manufacture

Product, Analytical Methods

Applicant




77084

S

Roal Ltd

Certificate of Analysis, Quantum Blue 5G, Lot C110620-35A

27 September 2012

Chemistry and Manufacture

Product, Batch Analysis

Applicant




77083

S

Roal Ltd

Certificate of Analysis Quantum Blue 5G, Lot C120311-35

27 September 2012

Chemistry and Manufacture

Product, Batch Analysis

Applicant




77081

S

Roal Ltd

Analysis of main and side activities, chemical composition and purity of Quantum Blue 5G (Complete full analysis of three batches, C100611, C100922 & C110110)

24 January 2012

Chemistry and Manufacture

Product, Batch Analysis

Applicant




77082

S

Roal Ltd

Certificate of Analysis, Quantum Blue 5G, Lot C100611

4 November 2011

Chemistry and Manufacture

Product, Batch Analysis

Applicant




77071

S

AB Enzymes

To evaluate temperature optimum of Quantum Blue

1 February 2012

Chemistry and Manufacture

Product, Other Information

Applicant




77070

S

AB Enzymes

To evaluate pH optimum of Quantum Blue Phytase

28 November 2011

Chemistry and Manufacture

Product, Other Information

Applicant




77072

S

AB Enzymes

To evaluate the stability of phytase activity of Quantum Blue 5 G when stored at 25 degrees C/60% RH and 40 degrees C/75% RH

4 October 2012

Chemistry and Manufacture

Product, Stability

Applicant




77075

S

AB Enzymes

To evaluate the stability of Quantum Blue 5 G in mineral premixtures for broilers when stored at room temperature (20-23 degrees C) for 6 months

12 October 2011

Chemistry and Manufacture

Product, Stability

Applicant




77076

S

AB Enzymes

To evaluate the stability of Quantum Blue 5 G in mineral premixtures for turkeys when stored at room temperature (20-23 degrees C) for 6 months

12 October 2011

Chemistry and Manufacture

Product, Stability

Applicant




77077

S

AB Enzymes

To evaluate the stability of Quantum Blue 5 G in mineral premixtures for piglets when stored at room temperature (20-23 degrees C) for 6 months

31 October 2011

Chemistry and Manufacture

Product, Stability

Applicant




77078

S

Enzyme Services & Consultancy (ESC). UK

Analysis of feed samples containing QPT2 by Quantum method of analysis, from Virginia Tech trial, QPT2 120: Month 1, 2 and 3 of a room temperature storage (stab) test

25 August 2011

Chemistry and Manufacture

Product, Stability

Applicant




77079

S

Enzyme Services & Consultancy (ESC). UK

Analysis of feed samples containing QPT2 by Quantum method of analysis, from trial code QPT2_8_6: Month 1, 2 and 3 of a room temperature storage (stab) test

10 August 2011

Chemistry and Manufacture

Product, Stability

Applicant




77080

S

Enzyme Services & Consultancy (ESC). UK

Analysis of feed samples containing QPT2 by Quantum method of analysis, from trial code QPT2 10_03 with subsequent storage for three months and testing monthly (stab tests) for phytase activity

22 June 2011

Chemistry and Manufacture

Product, Stability

Applicant



External Efficacy Reviewer


The applicant provided evidence in the form of studies carried out in pigs (1), turkeys (1) and broiler chickens (2) to support claims of efficacy and safety. The studies were carried out overseas and in Australia and were conducted under appropriate conditions with appropriate controls and adequate numbers to achieve credible results.

Overall, improvements in the utilisation of phytate P were adequately demonstrated in addition to reduced levels of P in excreta. No safety issues associated with the use of phytase were noted in any of the target species. The data demonstrate the product is safe and effective for use as per the label claims and instructions.



Data relied on to provide the advice

Data No

Data Source*

Author(s)

Title

Date

Data Type

Data Sub-type

Authorising Party

Inherited Application No.

77063

S

M. Bulang - Martin-Luther University, Germany

Study effects of QPT2 phytases on P digestibility in growing turkeys - Trial No. QPT2_8_04. Martin-Luther University, Germany

20 December 2011

Efficacy and Safety

Efficacy

Applicant




77064

S

K. Partanen - MTT Agrifood Research, Finland

Optimising the use of phytase in diets for weaned piglets - Trial No. QPT2_10_03

5 October 2012

Efficacy and Safety

Efficacy

Applicant




77065

S

A. Cowieson, S. Wilkinson, E. Bradbury & J. Gill - University of Sydney

Evaluation of the thermostability of exogenous phytases and their influence on broiler growth performance and skeletal integrity - Trial No. 01.11. PRF Ref. Thermo 01.11

2011

Efficacy and Safety

Efficacy

Applicant




77062

S

Bangkok Animal Research Centre Co., Ltd

Evaluation of super doses of phytase on broiler performance - Trial No. AB11229A

2011

Efficacy and Safety

Efficacy

Applicant




* S = Data submitted with the application

I = Data inherited (that is, referenced) from another application

59049 Page of KP25S_F39 Version: 2 Issued: 14/08/2007

Directory: advice summaries


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