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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?