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

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SteveK

Although the 2007/47/EC update of 93/42/EC (specifically Section 7.5 of Annex I) does not become mandatory until March 21st 2010 (though National implementation by 21st December 2008), has anyone started labelling devices (or the packaging of) containing phthalates – plus justifying the use within technical files/instructions for use? We supply products “…intended to administer and/or remove medicines…..” which have a PVC (and therefore phthalate) component, and are obviously reluctant to start the ball rolling:(. There is so much “stuff” out there manufactured from PVC that comes under the Directive (blood bags, face masks, tubing etc), so there must be a number of Covers affected. The only thread I have found on phthalates concerns REACH, which is a different, if related animal. Any comments?
 
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MIREGMGR

Re: Use of phthalates - MDD 2007/47/EC

We're not labeling in accord with that standard yet.

For several years, we've been voluntarily labeling certain disposable product ranges with a "no PVC" symbol and legend when applicable, primarily because of customer interest. That however is not being done in a way that is future-regulatory-compliant.

One thing that we are doing is working toward offering a non-PVC, or at least non-phthalate-plasticized, alternate product in all cases. We want those customers that are sufficiently concerned or constrained regarding PVC to still be able to buy from us.
 

chris1price

Trusted Information Resource
Re: Use of phthalates - MDD 2007/47/EC

Hi

Good question. At the moment, some of our products we obtain from suppliers still contain DEHP while others do not. These are labelled as "DEHP free". We are pressing the suppliers to look carefully at this, but there appears to be "head in the sand" attitude.

May 2010 is not far away and there ill be lots of last minute work to be done.

Chris
 

gpainter

Quite Involved in Discussions
Re: Use of phthalates - MDD 2007/47/EC

In the US The Consumer Product Safety Improvement Act Of 2008 (HR 4040) is requiring testing for phthalates for childrens products in the 12 and under range, in addition to stricter lead requirements. We have are product in tha lab being tested as I e-mail.
Lead content:
600 ppm 2/10/09
300 ppm 8/14/09
100 ppm 8/14/11 ?

Phthalates:
Children articles can not contain concentrations of more than .1% of DEHP, DBP or BBP
 
M

MIREGMGR

Re: Use of phthalates - MDD 2007/47/EC

We've been carefully studying the CPSC Consumer Product Safety Improvement Act of 2008, particularly as it pertains to phthalate plasticizers. Unless further court interpretation of applicability occurs before the implementation date (postponed recently until February 10, 2010), it will apply to products intended for a child 12 years of age or younger for use when playing, generally following the mandatory toy standard which exempts non-toy products.

It also will apply to products that a child 3 and younger would use for sleeping, feeding, sucking or teething.

At least under the CPSC's presently intended interpretation, it appears to exempt products used in medical care (with the exception of pediatric bed components) and in drug administration. However, there is a potential that the law could be ruled applicable to age-3-and-under pediatric medical care or drug administration where one aspect of that care is loss of consciousness or a quasi-sleep-like state, such as in anesthesia.

For more info, including a highly technical chemical-test procedure for evaluation of phthalate content in plastics, see the CPSC website.
 
S

SteveK

Re: Use of phthalates - MDD 2007/47/EC

Just to answer my own original question, there does now seem to be a draft standard for labelling medical devices containing phthalates in the ether (committee CEN/CLC TC 3/WG 1 N31). This looks like it will be published this year. The symbol for “Contains or Presence of Phthalates” will be as per attachment.

Until it is actually published, then I cannot see that there is a labelling requirement just yet (i.e. still not until March 2010).

Steve
 

Attachments

  • PHT.jpg
    PHT.jpg
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red_wood

Re: Use of phthalates - MDD 2007/47/EC

Hi SteveK,
Do you have the link to the draft standard (committee CEN/CLC TC 3/WG 1 N31) you mentioned? Thanks!
 
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SteveK

Re: Use of phthalates - MDD 2007/47/EC

Hi Red Wood,

As a company we are members of BAREMA (just google it). The link is on the members section - so unless you are a member I cannot supply the link.

Sorry!

Steve
 
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MIREGMGR

Re: Use of phthalates - MDD 2007/47/EC

Until it is actually published, then I cannot see that there is a labelling requirement just yet (i.e. still not until March 2010).

Any information available yet...does the March 2010 date pertain only to sales by manufacturers, or does it pertain to sales to end users?

In the latter case, of course, the requisite labeling changes would have to be implemented sufficiently before the March 2010 date that all of the product held by distributors and otherwise in the distribution channel would be compliant with the new regulation by that date.

Also, do we know yet what the "presence" level is likely to be? Canada for instance is using a 0.1% level for their advisory DEHP inquiries. As we know, phthalates are sufficiently invasive and environmentally omnipresent that they exist at PPB levels in many materials for which they are not a specified constituent, and in many customers' bodies.
 
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red_wood

Re: Use of phthalates - MDD 2007/47/EC

Please find below guidance published by Eucomed on the proposed symbols for devices containing phthalates to communicate to community and Medical staff.

Hope this is useful.
 

Attachments

  • Labeling of MD containing phthalates(Eucomed)_July09.pdf
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