of 2012 that furfural is safe for use in cosmetics at
concentrations of up to 0.001%, 17 the ingredient
will not be banned, but restricted. The draft regulation lists furfural in Annex III of the Cosmetics
Regulation in order to restrict its use in line with
the SCCS opinion. It should be noted that furfural is
restricted by the IFRA Code of Practice to concentrations ranging between 0.001 and 0.05% depending
on the product type. Nevertheless, changes to the
Cosmetics Regulation are legally binding.
Musk xylene, which is currently listed in entry 96
of Annex III of the Cosmetics Regulation, is classified
as a Category 2 carcinogen in Annex VI of the CLP
Regulation. Although the last published scientific
opinion, dated 2004, considered musk xylene is safe
at the currently permitted concentration levels, 18 as
there has been no additional assessment by the SCCS
regarding the safety of this ingredient in cosmetic
products, musk xylene will be included in entry
1389 of Annex II of the Cosmetics Regulation and
deleted from Annex III, and thus banned from use in
cosmetic products. In line with this, musk xylene is
prohibited in fragrances according to the IFRA Code
of Practice, and its concentration limited below 0.1%
in musk ketone preparations.
The safety of cosmetic products containing
fragrances marketed in the EU is accomplished
through the application of both voluntary and
legally binding measures (the IFRA Code of Practice
and the EU Cosmetics Regulation, respectively).
Restrictions on the usage of fragrance ingredients
stated in both texts do not always coincide, with the
(legally binding) Cosmetics Regulation often being
more restrictive than the IFRA Code of Practice.
Therefore, following the IFRA recommendations,
although intended to ensure product safety, does not
fully guarantee regulatory compliance of a fragrance
in the EU, as fragrance houses wishing to sell their
products in the EU must also ensure full compliance
with the provisions of the Cosmetics Regulation.
2. Regulation (EC) No 1223/2009 of the European Parliament and
of the Council of 30 November 2009 on cosmetic products.
3. SCCS/1588/17. Checklists for Applicants submitting dossiers
on Cosmetic Ingredients to be evaluated by the SCCS, 7 March
4. Commission Regulation (EU) 2017/1410 of 2 August 2017
amending Annexes II and III to Regulation (EC) No 1223/2009
of the European Parliament and of the Council on cosmetic
5. SCCS/1459/11 Opinion on fragrance allergens in cosmetic
products, 13-14 December 2011.
6. SCCP/0869/05 Opinion on Tagetes erecta, T. minuta and T.
patula extracts and oils (phototoxicity only), 30 June 2005.
7. SCCS/1551/15 Opinion on the fragrance ingredients Tagetes
minuta and T. patula extracts and essential oils (phototoxicity
only), 25 March 2015.
9. IFRA Analytical Working Group. Analytical method to
quantify 57 suspected allergens (and isomers) in ready to
inject fragrance materials by gas chromatography and mass
spectrometry. November 15, 2016.
10. SCCP/0984/06 Opinion on vetiveryl acetate (sensitization only),
28 March 2006.
11. SCCS/1541/14 Opinion on the vetiveryl acetate, 16 December
12. SCCS/1540/14 Opinion on the Buthylphenyl methylpropional,
12 August 2015, revision of 16 March 2016.
13. QRA Expert Group. Dermal Sensitization Quantitative Risk
Assessment (QRA) for Fragrance Ingredients. Final Revised
Report, 22 June 2006.
14. SCCP/1153/08 Opinion on dermal sensitization quantitative
risk assessment (Citral, farnesol and phenylacetaldehyde), 24
15. Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on classification,
labelling and packaging of substances and mixtures, amending
and repealing Directives 67/548/EEC and 1999/45/EC, and
amending Regulation (EC) No 1907/2006.
16. Regulation (EC) No 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the
European Food Safety Authority and laying down procedures
in matters of food safety.
17. SCCS/1461/12 Opinion on furfural, 27 March 2012.
18. SCCNFP/0817/04 Opinion of the Scientific Committee on
Cosmetic Products and Non-food Products intended for
consumers concerning musk xylene and musk ketone, 25
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