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REACH introduced the first time an authorisation requirement for common chemicals into the chemicals legislation of the EU.
The technical regulation restricts international trade by imposing an authorisation requirement for SVHC listed in Annex XIV REACH and that are used in imported articles.
As a consequence, such articles may be imported into the EEA subject to the requirements of Art. 7 REACH, but there is no authorisation requirement for REACH Annex XIV SVHC contained.
There's no authorisation requirement for campaign materials, which means no one has to put their name to what they say.
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"The PRA is therefore reforming its authorisation requirements for banks in ways that reduce barriers to entry.
Owing to these scaled down market authorisation requirements for biosimilars, it is expected that pharmaceutical companies can produce biosimilars at a lower cost while ensuring their quality, safety and efficacy.
From a procedural point of view an assessment is necessary whether the risk assessment provided for in the extended authorisation requirement is appropriate to determine risks in terms of Art.
56(1) REACH a manufacturer, importer or downstream user shall not place an Annex XIV substance on the market for use or use it himself, unless this use is exempt from the authorisation requirement or the actor, or his supplier, respectively, attained an authorisation for the corresponding use.
The extended authorisation requirement constitutes a ban and at the same time puts economic operators in a position to apply for authorisation (preventive ban with permit reservation).
After expiration of the transitional period for each Annex XIV-SVHC, articles, such as most products of daily use, produced in the European Economic Area (EEA) may not contain such substances unless an authorisation was granted for the specific use or this use falls within the scope of an exemption from the authorisation requirement.
This is also the case with respect to the extended authorisation requirement.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com