Use of Phthalates (PVC) - MDD 2007/47/EC - Has anyone started Labelling Devices

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Michael Malis

Quite Involved in Discussions
#63
... related to "Phthalates"...labelling, still very confused. ....
1. do we need to specified on the label that which PHT we used?
2. does any document said we only need to do the labelling if the PHT is above ?% ?

Appreciate if anyone could share your experience,

Thank you~:eek:
Hi Parsha,

1. You do need to specify the type of phthalate you use. Please see Eucomed guidance document for the latest example of symbols.

2. According to MDD, labeling is required regardless of % of PHT in use

Please let me know if you have any other questions.

Regards,
Mike
 
T

Tiffany

#64
Hi all,

I am revising my Techical File and product labelling now. Any updated news on the status symbol for "free of phatalates"???

TIffany

:cool:
 

Jean_B

Trusted Information Resource
#65
In labelling devices for phthalate presence, is it allowed to leave the warning symbol (in our case due to possible DEPH) on the labelling if some of the produced product batches do not have it, while some do due to using two supplier sources? Or do we need distinct labelling for each case?
Risk-based common-sense says we're not claiming a positive thing by the warning so leaving it on in DEPH-free products does not impose any additional health risk. However, legally compliance may frown upon this approach as being non-specific.

An analogy would be that a product is allowed to contain the warning "may contain (traces of) nuts", and that particular product batch not having them does not necessitate the removal of that warning. Does this hold for phthalates labelling or not?
 

Michael Malis

Quite Involved in Discussions
#66
Hi Jean,

Your analogy will not be appropriate to someone allergic to nuts.
The same can be true for Phthalates and therefore, you can't "rationalize it or risk it" due to convenience.

Regards,
Mike
 

Ronen E

Problem Solver
Staff member
Moderator
#67
Hi Jean,

Your analogy will not be appropriate to someone allergic to nuts.
The same can be true for Phthalates and therefore, you can't "rationalize it or risk it" due to convenience.

Regards,
Mike
Phthalates aside, I don't understand what you're saying.

Someone allergic to nuts can't be hurt by a nut-free food that is labeled "may have traces of nuts". You could argue that that person is harmed by not being able to consume such a food, but I think that that harm is acceptable from a public safety perspective.

There could have been an issue if the device was the only of its kind and was life-supporting, life-sustaining or the like, because then it could have been unduly prevented from people who have no alternative.
 
Last edited:

Michael Malis

Quite Involved in Discussions
#68
...Someone allergic to nuts can't be hurt by a nut-free food that is labeled "may have traces of nuts". You could argue that that person is harmed by not being able to consume such a food, but I think that that harm is acceptable from a public safety perspective...
.
When someone allergic to nuts start to choke in front of you, you will understand.
But this aside, the issue is about the truth of the information. You may or may not know, but small % of population is definitely allergic to Phthalates and therefore, it is not allowed "to leave the warning off"

As I stated in 2010, "labeling is required regardless of % of PHT in use"
 
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Ronen E

Problem Solver
Staff member
Moderator
#69
When someone allergic to nuts start to choke in front of you, you will understand.
But this aside, the issue is about the truth of the information. You may or may not know, but small % of population is definitely allergic to Phthalates and therefore, it is not allowed "to leave the warning off"

As I stated in 2010, "labeling is required regardless of % of PHT in use"
Sorry, I still don't understand your argument.

I never argued for or supported not labelling products that contain allergens, regardless of concentration. That's quite obvious. The current discussion is about giving a redundant/excessive warning on a product that DOESN'T contain the allergen AT ALL. If there are absolutely no nuts (not even traces) in a food, no one - not even a person severely allergic to nuts - can have an allergic reaction to them (how certain we are that there are absolutely no nuts inside, and how/whether can that be verified/guaranteed is a separate question, not the focus of the current discussion). The same goes for phthalates. So the worst such an excessive warning can cause is unduly prompting NOT using the device where phthalates allergy is known to exist or is suspected or even just possible (depends on how cautious the user is). If the device is life-supporting / life-sustaining or "just" very important for the patient, and no other phthalate-free alternative exists / is affordable / is practically available, this can become a serious issue; but as you can see a lot of "if"s need to come true in order for that to happen. Anyway, the associated harm is completely different from someone choking on nuts due to allergy.

In my opinion the regulation/guidance that I know is not clear enough in that case to give a definite answer to the OP. I'm quite sure that the authorities (FDA etc.) will rule that a phthalates warning should not be on the device if it's known not to contain any, if they will be asked a direct question. From a practical / reasonable point of view I think though that the right way to go is to apply risk management (again, not to the allergic reaction harm but to the lack of medical treatment). It might be a low risk, common device where the outcome would be quite obvious.
 
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Michael Malis

Quite Involved in Discussions
#70
I understand your point, but FDA (or any other agency) does not require labeling for manufacturing company to state "what is not present" in the product. Therefore, for 2 examples above, 2 separate labels are appropriate. One is "clean" and another with the presence of phthalate
 
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