Ref. Ares(2015)5006757 - 11/11/2015
Ref. Ares(2016)6036878 - 20/10/2016
To:
(GROW);
(GROW);
(TRADE)
Cc:
(TRADE);
(TRADE)
Subject:
TTIP and Cosmetics phone call with Cosmetics Europe on 02/07/2015
DG TRADE and GROW officials discussed TTIP and Cosmetics with Cosmetics
Europe on 02/07/2015
• COM noted that main difficulty remains the fact that several products (e.g.
sunscreens) are classified in the US as Over the Counter Drugs (OTCs)
whereas in the EU they are classified as cosmetics. This leads to very
different assessment and approval procedures. US is unlikely to change the
definition of cosmetics. It is also not clear if it is possible to distinguish
between primary and secondary functions of UV filters. There were some
initiatives from the US consumers that pleaded for a faster approval of UV
filters in the US. The EU position paper of March 2015 is still valid. There is
no legal text available.
• Cosmetics Europe noted that the US Sunscreen Innovation Act does not
define what scientific data will be required to prove safety of UV filters. This
will be done later by means of FDA guidance
• A pilot project on a concrete UV-filter already approved in the EU (including
the data submitted) but not yet in the US could be developed (It could be
however challenging to identify a UV filter + address teh human resources
needed)
• Cosmetics Europe enquired why allergens would be put forward as a TTIP
discussion area. COM clarified regulatory cooperation in new/non regulated
areas is useful. There is however no particular regulatory objective.
• As regards harmonization of labelling requirements, the financial benefit
seems to be limited
Participants:
,
(DG TRADE);
,
(DG GROW)
Gerard Renner (Cosmetics Europe)
European Commission
Directorate General for Trade