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Application A490 – Exemption of Allergen Declaration for Isinglass – Draft Assessment Report

11 November 2008

Dear Sir/Madam

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority (NZFSA) has the following comments to make on the Draft Assessment Report (DAR).

Summary of preferred option

NZFSA supports Option 2, subject to the condition below – Prepare a draft variation to the Table to clause 4 of Standard 1.2.3 to grant an exemption from the requirement to declare isinglass on the label, when present in beer and wine as a result of its use as a clarifying agent.

The condition is that FSANZ consider making it a requirement that only isinglass with substantially reduced levels of parvalbumin be exempt from allergen declaration for isinglass. This could be achieved, for example, through an industry guideline or Code of Practice, requiring wine and beer manufacturers to comply with the “new code of GMP” (Good Manufacturing Practice) for the sourcing and use of isinglass as outlined in the DAR.

Reasons for suggesting a condition associated with option 2.

The DAR states that the three major European manufacturers of isinglass have developed a common code of GMP for the sourcing and manufacturing of isinglass (hereafter referred to as the “new code of GMP”). This new process aims to reduce the parvalbumin content in isinglass. The report also states that the Applicant claims that nearly 100% of the isinglass used in New Zealand and Australia is sourced from these three manufacturers.

NZFSA is concerned that “nearly all” is not ALL therefore some isinglass used in the production of wine and beer in New Zealand and Australia is not sourced from the three European manufacturers using the “new code of GMP”. Isinglass not manufactured under the “new code of GMP” is considered to contain higher levels of parvalbumin and therefore puts fish allergic consumers at a higher risk of having an allergic reaction. There is also no guarantee that imported wines from countries other than New Zealand or Australia use isinglass manufactured to this new Code and therefore fish allergic wine and beer consumers are at risk of having an allergic reaction.

For this reason we recommend that FSANZ consider making it a requirement that only isinglass manufactured under the “new code of GMP” (or isinglass with substantially reduced levels of parvalbumin) be exempt from allergen declaration for isinglass.

Additional comments on the Draft Assessment Report

Correct use of term GMP

Throughout the report the term GMP has been incorrectly referred to as Good Management Practice. The term GMP applies to Good Manufacturing Practice which is a different practice to Good Management Practice. Isinglass is permitted to be used as a clarifying agent to a GMP level (Standard 1.3.3 of the Code) and GMP is clearly defined as Good Manufacturing Practice in the interpretation clause of this Standard. This should be corrected in the Final Assessment Report.

Risk assessment

NZFSA agrees with the conclusion in the FSANZ risk assessment (paragraph 4 of the Risk Assessment Report) that if industry uses isinglass prepared under the industry agreed GMP, then the risk of exposure to fish allergens is expected to be extremely low.

We do however have some concerns in relation to the evidence supplied by the applicant on which this risk assessment was based. These same concerns were raised in the Opinions of the Scientific Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority (the Panel). NZFSA asks that these concerns be addressed in the Final Assessment Report.

1) While there have been few if any documented reports of adverse events that can be attributed to fish allergy from consuming wine or beer fined with isinglass, it should be noted that there could be a significant underreporting of reactions to isinglass in wine because it is uncertain whether wine drinkers and health professionals have been aware of the possible presence of fish proteins in wine. (paragraph 8.1.1 of the DAR)

2) The literature review was based on one search engine and used only two search terms. The Panel noted certain limitations associated with the restricted search strategy used. This would not support the statement in the DAR that a comprehensive literature search was undertaken. (paragraphs 6.4.1 and 8.1.1 of the DAR)

3) Test results of isinglass residues in wine and beer. The DAR (paragraphs 6.5.1 and 6.5.2 and 8.2.1) concludes that the wine and beer making processes appear to remove the majority of the isinglass. Therefore the level of residual level of isinglass in the fined beer or wine is expected to be low and testing has confirmed this. However the Panel noted that there were “uncertainties with regard to the accuracy and appropriateness of the cod parvalbumin-based ELISA for the assessment of parvalbumin in tropical fish-derived isinglass”. Therefore testing for residual isinglass should be treated with caution.

4) The results of the clinical studies need to be treated with caution as the test numbers are small and therefore have limited statistical power. (paragraph 8.1.1 of the DAR)

5) One of the double blind placebo controlled food challenges used isinglass in mashed potatoes. The Panel noted that this trial was performed in a food matrix in which isinglass is not usually consumed. In addition it noted that alcohol is considered to lower the dose that may trigger a food allergic reaction in susceptible individuals. (paragraphs 6.8.2 and 8.1.1 of the DAR)

6) The high susceptibility of isinglass to pepsin digestion is presented as evidence of non-allergenicity. The Panel noted that this method is “unsuitable for assessing the allergenicity of isinglass”. While most known allergens are resistant to pepsin digestion this is not a necessary condition for allergenicity. (paragraph 6.8 of the DAR)

Summary

We note that the Scientific Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority took a cautious approach when presenting its opinions on isinglass used in the manufacture of wine being exempt from labelling, particularly where there was insufficient information available on which to base an opinion. Despite this a permanent exemption for isinglass used as a fining agent in both beer and wine was granted in 2007.

We note that FSANZ has based its assessment and preferred regulatory option on the same information as that used by the European Union when it made its decision to grant a permanent labelling exemption for isinglass used as a fining agent in wine and beer. We assume that the evidence provided by the beer industry which used isinglass manufactured under the new code of GMP was extrapolated for wine, however this is not made clear in the DAR. We ask that FSANZ provide the scientific evidence in the Final Assessment Report that would support this extrapolation. Without this evidence we believe there is a sound basis to impose the condition associated with regulatory option 2, as proposed by NZFSA.

However as with all regulation it is essential that regular reviews are undertaken, and if necessary amendments are made, especially if reactions do start to occur.

Yours sincerely