Published: 18 March 2019
Consultations
Outcome of the consultation on the proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products
Summary
About the consultation
Submissions received
Consultation feedback and Medsafe’s response
Outcome
Implementation
Enquiries
Summary
- Medsafe sought comments on a proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products.
- Medsafe received 18 submissions in response to the consultation.
- After careful consideration, Medsafe has decided the following statement should be included in the Label Statements Database – Caution: This product may make dressings and clothing catch fire more easily with a naked flame.
- The warning statement will only apply to products containing 50% or more of paraffin and only apply to packs of 100 g or more.
- This warning statement will be required to be placed on labels from 1 May 2020.
About the consultation
At the end of 2018, Medsafe sought comments on a proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products. Specifically:
- whether a warning statement is required in the Label Statement Database
- the wording of the warning statement
- whether a warning statement is required on all products containing emulsifying wax, liquid paraffin or white soft paraffin
- whether a warning statement should be used on all pack sizes.
Medsafe would like to thank all those who took the time to respond to the consultation and provide comments.
Additional information on this closed consultation
Submissions received
Medsafe received 17 submissions on the Citizen Space platform, and one by email. Half of the submissions were made by an individual (not on behalf of an organisation or in their professional capacity). Half of the submissions were made on behalf of a group or organisation and included four sponsors, one supplier, one professional body and three industry organisations.
Eight submissions are published below. Personal information that can identify submitters has been removed where requested. Ten submissions have not been published because permission to publish was withheld.
- Pharmaceutical Society of New Zealand (PDF 10 KB, 2 pages)
- General Practitioner (PDF 10 KB, 2 pages)
- General Practitioner (PDF 9 KB, 10 pages)
- Douglas Pharmaceuticals Limited (PDF 12 KB, 3 pages)
- Pharmacy Guild of New Zealand (PDF 15 KB, 3 pages)
- Clinical pharmacist (PDF 9 KB, 2 pages)
- Australian Self Medication Industry (PDF 10 KB, 2 pages)
- New Zealand Self Medication Industry (PDF 145 KB, 1 page)
Consultation feedback and Medsafe’s response
- Should a warning statement about a fire hazard be included on the
package labels of paraffin-based skin products?
Fourteen submissions answered yes (82%) and three answered no (18%).The submissions mostly agreed with including a warning statement, especially for products that are likely to be applied to the skin in large quantities. Those that did not agree commented that a warning statement may cause unnecessary alarm for patients. Concerns were raised over the requirement for the statement on inappropriate products, such as eye ointments.
Medsafe will include a warning statement in the Label Statements Database. The condition for ‘dermal use’ in the Label Statements Database should exclude inappropriate products, such as eye ointments. Eye ointments are not typically applied to the dermis.
- Would you prefer Option 1 or Option 2 as a warning statement?
Four submissions preferred option 1 (24%) and 13 preferred option 2 (76%).The submissions preferred Option 2 overall. The submissions commented that a shorter warning statement is clearer and can fit on smaller packs.
Medsafe will use Option 2 as a warning statement.
- Does Option 1 adequately address the fire hazard risk (ie, Caution:
If this product comes into contact with dressings and clothing, the
fabric can be more easily ignited with a naked flame. You should keep
away from fire when using this product)?
Twelve submissions answered yes (75%) and four answered no (25%).Although the submissions agreed overall that Option 1 adequately addresses the fire hazard, there was a theme in the submissions that the statement was too long and contained too much information.
Medsafe notes the responses and comments received.
- Does Option 2 adequately address the fire hazard risk (ie, Caution:
This product may make dressings and clothing more easily ignited with
a naked flame)?
Twelve submissions answered yes (71%) and five answered no (29%).Overall, the submissions agreed that Option 2 adequately addresses the fire hazard. A number of suggestions for alternative wording for the statement were made, including the use of a fire safety symbol. The words ‘catch fire’ instead of ‘ignited’ were suggested by a couple of submissions. ‘Catch fire’ is easier to understand and is more active.
Medsafe notes the responses and comments received. ‘Ignited’ will be changed to ‘catch fire’. Words of a similar meaning to the statements in the Label Statements Database may be used which allows for similar alternative wording and a fire safety symbol to be used.
- Should the warning statement only apply to products containing 50%
or more of paraffin?
Fifteen submissions answered yes (88%) and two answered no (12%).Some submissions queried at what strength of paraffin a product would make dressings and clothing more easily ignited. However, overall the submissions commented that products containing 50% or more of paraffin appear to be those associated with the greater risk.
Medsafe will ensure the warning statement only applies to products containing 50% or more of paraffin.
- Should the warning statement only apply to packs intended for use
in large quantities (eg, pack size of 50 g or more)?
Ten submissions answered yes (59%) and seven answered no (41%).The submissions agreed overall that the warning statement should only apply to packs intended for use in large quantities. There is limited space on smaller pack sizes and these are not likely to be used in large quantities. A lot of these products are sold over-the-counter and are also not required to have data sheets or Consumer Medicine Information. A number of submissions suggested a pack size of 100 g or more.
Medsafe will ensure the warning statement only applies to packs of 100 g or more.
- Do you have any other comments about a proposed warning statement
regarding a fire hazard on the labels of paraffin-based skin products?
One submission queried whether the reference to emulsifying wax is correct. Emulsifying wax is a component of emulsifying ointment. In response to this submission, Medsafe has removed emulsifying wax from the proposed Medicine/Group/Class column.A recurring theme in the submissions was that adding a label statement alone was not adequate in mitigating the potential risk. Also, the Label Statements Database applies to medicines and related products. Some paraffin-based skin products are cosmetics or devices and so the requirements of the Label Statements Database are not applicable.
Medsafe will write an article in Prescriber Update and will produce a Consumer Information Leaflet, both of which will be published on the Medsafe website. The article and leaflet will include advice on the risk of using paraffin-based skin products, such as not to smoke / use naked flames and to change clothing / bedding regularly. Medsafe encourages the professional bodies and industry organisations to build on these information sources and develop an educational and awareness campaign.
Outcome
Medsafe will update the Label Statements Database to include the following warning statement regarding a fire hazard on the labels of paraffin-based skin products:
| Medicine/Group/Class | Conditions | Statements or requirements | Required by |
|---|---|---|---|
| Emollient Includes: Liquid paraffin White soft paraffin |
For dermal use in products containing 50% or more of paraffin and in packs of 100 g or more |
|
01/05/2020 |
Implementation
This warning statement will be required to be placed on labels from 1 May 2020. The Label Statements Database will be updated to this effect.
Enquiries
Any questions relating to this consultation should be directed via email to: medsafeapplications@health.govt.nz
