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EU Prohibits the Use of 5 Parabens and Restricts the Use of Triclosan in Cosmetic Products

In order to ensure the safety of cosmetic products for human health, the European Commission has adopted REGULATION (EU) No 358/2014 that prohibits the use of 5 parabens and limits the maximum concentrations of Triclosan in cosmetic products. This was published in the Official Journal on 9 April 2014 and amends Annexes II and V of existing Regulation (EC) No 1223/2009.

Background

The Scientific Committee on Consumer Safety (SCCS) has called for toxicological data and a complete dossier of toxicity of long-chain parabens for evaluation. However, since there is limited information submitted for safety evaluation of isopropyl-, isobutyl-, phenyl-, benzyl-, and pentylparaben, human risk cannot be evaluated. In addition, SCCS confirmed the Scientific Committee on Consumer Products (SCCP) position to consider that the continued use of triclosan as a preservative at the current maximum concentration limit of 0,3 % in all cosmetic products would raise a potential risk to human health.

The European Commission has taken and adopted the opinions from SCCS, which are now incorporated into the EU Cosmetic Regulation EC 1223/2009 as an amendment, as follows:

Reference Number

Substance Identification

INCI Name/Chemical Name

CAS NO.

EC No.

A

B

C

D

1374

Isopropylparaben and its salts

4191-73-5

224-069-3

1375

Isobutylparaben and its salts

4247-02-3; 84930-15-4

224-208-8; 284-595-4

1376

Phenylparaben

17696-62-7

241-698-9

1377

Benzylparaben

94-18-8

-

1378

Pentylparaben

6521-29-5

229-408-9

Annex II (Prohibited List) is amended by including the following parabens in Entries 1374-1378.

Annex V (List of preservatives allowed) is amended and Entry 25 is replaced by the following table:

Ref No.

Chemical Name

Name of Common Ingredients Glossary

CAS No.

EC No.

Product type. Body parts

Max. concentration in ready for use preparation

Other

Wording of condition of use and warnings

a

b

c

d

e

f

g

h

i

25

5-Chloro-2- (2,4- dichlorophenoxy) phenol

Triclosan

3380-34-5

222-182-2

a)

  • Toothpastes
  • Hand soaps
  • Body soaps/Shower gels
  • Deodorants (non-spray)
  • Face powders and blemish concealers Nail products for cleaning the fingernails and toenails before the application of artificial nail systems

b)

  • Mouthwashes

(a) 0,3 %

 

(b) 0,2 %

 

 

Timeline

This regulation has entered into force in all Member States since the twentieth day following that of the publication in the Official Journal of the European Union. From 30 October 2014 onwards: New cosmetic products to be placed on the Union market have to comply with this regulation. From 30 July 2015 onwards: Any products not complying with this regulation must be removed from the market by this date.

It is crucial for all cosmetic, personal care and household products to be safe effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognised standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements. Please do not hesitate to contact us for further information or visit our website.

Email SGS Hong Kong Ltd. at mktg.hk@sgs.com for enquiries or visit http://www.sgsgroup.com.hk/.

Email SGS Hong Kong Ltd. at mktg.hk@sgs.com for enquiries or visit http://www.sgsgroup.com.hk/.
Content provided by SGS Hong Kong Limited
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