Proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

Response 484835008

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Your details

3. Are you providing feedback:

Please select one item
As an individual
Ticked On behalf of an organisation or group

4. Where are you or your organisation based?

Please select one item
New Zealand
Ticked Australia
Other

5. Which of the below options best describes you in the context of this consultation?

Please select one item
Healthcare professional
Member of the public
Sponsor
Manufacturer
Supplier
Importer
Government organisation
Researcher
Professional body
Industry organisation
Ticked Consumer organisation
Institution (eg, university, hospital)
Regulatory affairs consultant
Laboratory professional
Other

Antibiotics

1. Should labels include a warning statement for antibiotics?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for antibiotics?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for antibiotics?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Aspartame

1. Should labels include a warning statement for aspartame?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for aspartame?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for aspartame?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Benzoates

1. Should labels include a warning statement for benzoates?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Benzoic acid, Sodium benzoate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for benzoates?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for benzoates?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Crustacea and crustacean products

1. Should labels include a warning statement for crustacea and crustacean products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Crab, Crayfish, Lobster, Prawn, Shrimp)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for crustacea and crustacean products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for crustacea and crustacean products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Egg products

1. Should labels include a warning statement for egg products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Dried egg yolk, Egg, Egg lecithin, Influenza vaccine, Products manufactured in eggs)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for egg products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Ethanol

1. Do you agree with the proposed conditions for ethanol?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed warning statement for ethanol?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
i think it needs to be clearer to state "Contains Alcohol" as it could be confused to state "Contains Ethanol"

The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Fish and fish products

1. Should labels include a warning statement for fish and fish products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Cod, Cod liver oil, Halibut, Shark, Tuna)?

Please select one item
Yes
Ticked No
If no, please suggest alternative inclusions
Also include "freshwater fish, diadromous fish and marine fish including shark " in the Medsafe table to align with TGO92 more clearly

3. Do you agree with the proposed conditions for fish and fish products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for fish and fish products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Galactose

1. Should labels include a warning statement for galactose?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for galactose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for galactose?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Gluten

1. Should labels include a warning statement for gluten?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Ingredient derived from gluten-containing grain, Wheat starch)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for gluten?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for gluten?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Hydroxybenzoic acid esters

1. Should labels include a warning statement for hydroxybenzoic acid esters?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Ethyl hydroxybenzoate, Methyl hydroxybenzoate, Propyl hydroxybenzoate, Sodium ethyl hydroxybenzoate, Sodium methyl hydroxybenzoate, Sodium propyl hydroxybenzoate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for hydroxybenzoic acid esters?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for hydroxybenzoic acid esters?

If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Lactose

1. Should labels include a warning statement for lactose?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for lactose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for lactose?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Milk and milk products

1. Should labels include a warning statement for milk and milk products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Casein, Hydrolysed milk protein, Non-fat dry milk, Whey powder, Whole dry milk)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for milk and milk products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for milk and milk products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Peanuts and peanut products

1. Should labels include a warning statement for peanuts and peanut products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Arachis hypogaea, Arachis (peanut) oil)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for peanuts and peanut products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for peanuts and peanut products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Phenylalanine

1. Should labels include a warning statement for phenylalanine?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for phenylalanine?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for phenylalanine?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Pollen

1. Should labels include a warning statement for pollen?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for pollen?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for pollen?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Potassium salts

1. Should labels include a warning statement for potassium salts?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Potassium bicarbonate, Potassium chloride)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for potassium salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for potassium salts?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Propolis

1. Should labels include a warning statement for propolis?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for propolis?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for propolis?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Royal jelly

1. Should labels include a warning statement for royal jelly?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for royal jelly?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for royal jelly?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Saccharin

1. Should labels include a warning statement for saccharin?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Saccharin calcium, Saccharin sodium)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for saccharin?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for saccharin?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Sesame and sesame seed products

1. Should labels include a warning statement for sesame and sesame seed products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Sesame seed, Sesame oil, Sesamum indicum)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sesame and sesame seed products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sesame and sesame seed products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Sodium salts

1. Should labels include a warning statement for sodium salts?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Sodium bicarbonate, Sodium chloride)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sodium salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sodium salts?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Sorbic acid and sorbic acid salts

1. Should labels include a warning statement for sorbic acid and sorbic acid salts?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusion (Potassium sorbate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sorbic acid and sorbic acid salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sorbic acid and sorbic acid salts?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Soya beans and soya bean products

1. Should labels include a warning statement for soya beans and soya bean products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Glycine max, Soya bean, Soya oil)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for soya beans and soya bean products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for soya beans and soya bean products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Sucralose

1. Should labels include a warning statement for sucralose?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for sucralose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for sucralose?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Sugar alcohols

1. Should labels include a warning statement for sugar alcohols?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Erythritol, Isomalt, Lactitol, Maltitol, Mannitol, Polydextrose, Sorbitol, Xylitol)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sugar alcohols?

Please select one item
Yes
Ticked No
If no, please suggest alternative conditions
Need to understand why Medsafe call out to "exclude glycerol"?
TGO92 does not include this and by differing there is potential for different calculations of 2g per maximum recommended daily dose and therefore different labels

4. Do you agree with the proposed statement for sugar alcohols?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Sugars – monosaccharides and disaccharides

1. Should labels include a warning statement for sugars (monosaccharides and disaccharides)?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Fructose, Glucose, Honey, Invert sugar, Lactose, Maltose, Sucrose)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sugars?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sugars?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Sulfites

1. Should labels include a warning statement for sulfites?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Potassium metabisulfite, Sodium bisulfite, Sodium metabisulfite, Sodium sulphite, Sulfur dioxide (including residues))?

Please select one item
Yes
Ticked No
If no, please suggest alternative inclusions
TGO92 has Sodium Sulfite rather than Sodium Sulphite. Reccomend to align and call the inclusion Sodium Sulfite

3. Do you agree with the proposed conditions for sulfites?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sulfites?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Tartrazine

1. Do you agree with the proposed conditions for tartrazine?

Please select one item
Ticked Yes
No

Tree nuts and tree nut products

1. Should labels include a warning statement for tree nuts and tree nut products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Almond oil, Brazil nut, Cashew, Chestnut, Juglans nigra, Macadamia nut oil, Macadamia ternifolia, Prunus dulcis, Walnut)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for tree nuts and tree nut products?

Please select one item
Yes
Ticked No
If no, please suggest alternative conditions
TGO92 also include a a footnote to state "Coconut is the fruit of the palm (Cocos nucifera) and is not considered to be a tree nut." This would be helpful to include.

4. Do you agree with the proposed statement for tree nuts and tree nut products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
The use of the words 'Caution: contains' does not harmonize with the Australian TGO 92 labelling Order. The requirement to include the word “Caution” is a unique New Zealand requirement that has the potential to cause misalignment between the two markets. Should this requirement be retained, it has the potential for significant impact on Trans-Tasman labeling.
We propose to remove the word “Caution” preceding each disclosure statement in order to ensure alignment with Australia. The wording for each entry should be amended to state “Contains [ingredient].

Implementation date

1. Do you agree with the proposed implementation date of 1 September 2020 (1/09/2020)?

Please select one item
Yes
Ticked No
If no, please suggest an alternative date
• Implementation date- The proposed transition date of 1st September 2020 mirrors TGO 92 transition date. Sponsors with Trans-Tasman labelling may be able to meet this date, however, if Medsafe do not align the proposed warning statements with TGO 92, a 12 month transition is unrealistic.
In Australia, TGO 92 had a 4 year transition. We recommend a 4 year transition time for all products. This is necessary for New-Zealand only products and products where labels are not harmonised; it will also be necessary if there is no alignment with TGO 92.

Other comments

1. Do you have any other comments about this consultation?

Do you have any other comments?
Application and interpretation of transition-
The NZ LSDB does not specify the point at which transition applies, and for consistency we recommend that Medsafe aligns with Australia in defining this as the “release for supply” step. Having an aligned interpretation on timing of implementation assists sponsors/manufacturers in achieving compliance across both markets.
We recommend that Medsafe considers extending the transition period to 4 years and aligning on the interpretation on transition applying to the release for supply step.
Uncertainties
• Medsafe do not include threshold limits for declarations for some substances. This is problematic for substances that may be present in trace amounts. Sponsors are still unclear on how to assess risk when substances are not deliberately added but may be present as “traces”. This issue is still evolving with the TGA. Industry requires some assurance that Medsafe will align with the TGA in the way it interprets when a substance should be declared, in the absence of threshold or cut-off limits.
• If the TGA makes amendments to any guidance relating to declarable ingredients, we request that Medsafe also align to ensure that harmonisation is possible following any future updates.