employing a broad range of chemicals and clinical
data. In their opinion of 20115 the SCCS reiterated
this opinion. Following this evaluation, a new QRA
methodology has been developed (and named QRA
2), which reviews uncertainty factors and introduces dermal aggregate exposure data. In March
2017, the SCCS was requested an opinion on the
new methodology. The draft opinion is expected for
October 2017, which is the deadline set up in the
The CLP Regulation and Expected
Amendments to the Cosmetics Regulation
Although it does not directly address cosmetics,
the provisions of Regulation 1272/2008 (the CLP
Regulation) 15 do have an impact on these products.
According to Article 15 of the Cosmetics Regulation,
the use in cosmetic products of substances classified
under Annex VI to the CLP Regulation as CMR (
carcinogenic, mutagenic or reprotoxic) is prohibited.
Category 1A and 1B CMR substances (‘known’ or
‘assumed’ human CMRs) may still be used in cos-
metics only if they comply with the EU food safety
requirements16, there are no suitable alternative
substances available, an application is made for a
particular use of a product category with a known
exposure and they have been evaluated and found
to be safe by the SCCS for use in cosmetic products.
Category 2 CMR substances (‘suspected’ human
CMRs) may be used in cosmetic products if they
have been evaluated by the SCCS and considered to
be safe for use.
In July 2017, a draft Commission Regulation was
published which explicitly prohibits or restricts the
use in cosmetics of substances classified as CMR (in
any category) according to the CLP Regulation as at
1 January 2017, by including them in Annex II or III
of the Cosmetics Regulation. The deadline for com-
ments on this draft Regulation was 28 August 2017.
After this, the regulation is expected to be voted and
published in the OJ by the end of 2017. There will be
no adaptation period to the regulatory changes.
Some fragrance ingredients have been included in
this draft regulation:
Furfural (2-furaldehyde), which is used as a
fragrance ingredient in cosmetic products, is listed in
Annex VI of the CLP Regulation as a CMR substance
in Category 2. As the SCCS concluded in its opinion