REACH decision on articles could place demands on pharma industry
The European Union's REACH regulations may have implications for the pharmaceutical industry, even though medicines themselves are largely exempt.
The European Union's REACH regulations may have implications for the pharmaceutical industry, even though medicines themselves are largely exempt.
Administrative demands and environmental assessments may be made on the sector because of a current debate over what constitutes an "article" under REACH: whether it is an entire product, such as a packet of pills, or the individual elements making that product - the pills, the packet and its label.
If a European Commission committee decides it is the latter, then the packaging could be deemed "intentionally released" when thrown away, in which case the chemicals used in its manufacture may have to be registered, depending on volumes used.
Even if it is not, certain potentially hazardous chemicals used in label dyes or adhesives may be registered if they make up more than 0.1% of the weight of an item: a possibility if the label was considered alone, but not if the pills, packet and label were weighed together.