EU Cosmetic Regulation 1004/2014/EU to Restrict the Use of Certain Parabens in Cosmetic Products (30/12/2014)
The European Commission adopted a regulation that restricts the use of butyl and propyl parabens in leave-on cosmetic products designed for application on the nappy area of children below the age of three years.
In order to ensure the safety of cosmetic products for human health, the European Commission has adopted Regulation (EU) No 1004/2014 that restricts the use of butyl and propyl parabens in leave-on cosmetic products designed for application on the nappy area of children below the age of three years. This was published in the Official Journal on 18 September 2014 and amends Annexes V of existing Regulation (EC) No 1223/2009.
Parabens in Leave-On and Children’s Cosmetics
The Scientific Committee on Consumer Safety (SCCS) confirmed that concerning butylparaben and propylparaben present in leave-on cosmetic products designed for application on the nappy area of children below the age of six months, a risk could not be excluded in light of both the immature metabolism of such children and the possibility of damaged skin in the nappy area. Based on a worst case assumption of exposure, safety concerns might be raised.
The European Commission has overtaken (for practical reasons linked to the fact that products for infants are usually marketed for children under three years) and adopted the opinions from SCCS, and now it is incorporated into the EU Cosmetic Regulation EC 1223/2009 as an amendment.
Amended Annex V (List of preservatives allowed), replaced Entry 12, and Entry 12a are summarized in Tables 1 and 2 within the latest SafeGuards bulletin (newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-18214-10042014-eu-restricts-butyl-propyl-parabens-cosmetic-products-a4-en-14.pdf).
Regulation Timeline for Parabens in Cosmetics
This regulation entered into force on 16 October 2014.
From 16 April 2015 only cosmetic products which comply with this regulation shall be placed on the Union market.
From 16 October 2015 only cosmetic products which comply with this regulation shall be made available on the Union market.
- Opinion on Parabens (ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf), SCCS/1348/10 Revision 22 March 2011, adopted on 14 December 2010
- Commission Regulation (EU) No 1004/2014 (eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2014_282_R_0002&from=EN) of 18th September 2014 amending Annexes II to V to Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products
About SGS Cosmetic Safety Solutions
It is crucial for all cosmetic, personal care and household products to be safe, effective and stable. SGS provides testing (www.sgs.com/en/Consumer-Goods-Retail/Cosmetics-Personal-Care-and-Household/Cosmetics-and-Personal-Care/Testing.aspx), inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. The SGS state-of-the-art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. The company also has extensive capabilities in performance testing, claim support studies and consumer panels. Testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. The company’s cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.
Please contact an SGS expert for further information.
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