Ref. Ares(2015)5631410 - 07/12/2015
Ref. Ares(2016)6036878 - 20/10/2016
Directorate-General for Trade
Directorate F - WTO, Legal Affairs and Trade in Goods
TRADE F.3 Tariff and Non–Tariff Negotiations, Rules of Origin
Phone call between Cosmetics Europe and European Commission
List of attendees:
Discussion on technical details on the TTIP negotiations in particular as regards EU and
US approaches on cosmetics safety assessment methods.
UV filter pilot project:
1. The project should entail a detailed comparison of the EU and US requirements as
well as data which is to be submitted for an ingredient approval in the EU and in
2. A concrete UV-filter already approved in the EU (including the data submitted)
should be selected (which UV filter has not yet been decided)
3. Experts from US FDA and EU SCCS should assess jointly the complete dossier
and the reasons that led to the EU approval.
4. Ideally the pilot would comprise also, as outcome, recommendations on possible
alignment of EU and US requirements.
interested to interact with EU experts to better understand why EU regulates
sunscreens as cosmetics instead of over the counter drugs and the historical background
of EU regulation and cosmetics classification.
Video Conference (VC) on safety assessment of ingredients
VC is scheduled for 24/03/2015 with FDA drug experts (not linked with the pilot
project). Not yet decided who will attend VC from the EU SCCS.
welcomed, but it is not possible as she is not a member of SCCS anymore.
Several questions in the past arising from the assessment of the long term exposure
considering the fact that the extent of exposure is significantly higher than it was before.
(remark: EU safety assessment guidelines assume a 18g daily use as a maximum amount
on full body which is an over estimation of probable real exposure)
Main objectives of the DVC:
to demonstrate to FDA that our assessment system is detailed and appropriate
to present the different aspects that are looked at by SCCS experts as defined on
to present data needed to substantiate the safety
To present EU pharmacovigilance/cosmetics vigilance
According to the US post market data is not sufficient. Adverse reaction reporting does
not give appropriate information on carcinogenic long term effects. We have new legal
obligation now. Report from DE (UV filters were not on top of the list).
EU updates often list of allowed ingredients and new bans in light of new scientific
evidence becoming available. For instance, several endocrine disruptors have been
actively replaced/removed from list of allowed ingredients in the EU due to SCCS
Remark: Ideally US should be asked to consider daily use products containing small
quantities of UV-filters (e.g. facial creams) as cosmetics instead of sunscreens.
Minimum amount to test should be determined (likely higher than what is used daily in
practice) – to make sure results are reproducible
New US Cosmetics Innovation Act:
• Draft guidelines developed by FDA will be assessed by Cosmetics Europe.
International Cooperation on Cosmetics Regulation (ICCR):
• Cosmetics Europe would like to see formal recognition of ICCR as a fora having
high technical value (and strong mandate given to DG GROW to implement those
guidelines in EU legislation). Issues discussed by ICCR should inform/input into
the EU debate. How to make sure that EU and SCCS would take on board ICCR
• As regards ICCR and animal testing, several alternative test methods (ATMs)
have been validated and adopted in the EU. However, for some areas
implementation in the EU would be more difficult (e.g. ICCR discussions on