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As part of its plan to ensure the safety of hair dye products for human health, the European Commission has adopted Regulation (EU) No 1197/2013, limiting the maximum concentrations of 22 assessed hair dye substances. The new regulation was published in the Official Journal on November 26, 2013 and it amends Annex III of the existing Cosmetic Regulation (EC) No 1223/2009. See how the changes will affect the industry.

Backed By Scientific Data

Following the publication of a scientific study in 2001, entitled “Use of permanent hair dyes and bladder cancer risk”, the EU’s Scientific Committee on Cosmetic Products (SCCP) concluded that the health risks posed by certain substances used hair dye products were of real concern. As more than 60% of women in the EU and 5-10% of men color their hair on average 6 to 8 times per year, the move to ensure hair dyes contain only substances with established safety profiles had become a top priority.

The SCCP recommended that the Commission take further steps to control the use of hair dye substances. The SCCP, subsequently replaced by the current Scientific Committee on Consumer Safety (SCCS), set up an expert panel to assess the safety of individual substances for which updated files have been submitted by the hair care industry.

Common Strategy On Substances Regulation

The European Commission and European Member States agreed upon an overall strategy to regulate substances used in hair dye products. As part of the process, the SCCS expert panel performed risk assessments on all the substance files that were submitted by the industry.

After taking into account the final opinions given by the SCCS, the EU Commission adopted Regulation (EU) No 1197/2013, in order to achieve its goal of ensuring the safety of hair dye products for human health. Through the regulation, the Commission has decided to:

  1. Restrict The Use Of 21 Hair Dye Substances - by regulating them in Annex III to the Cosmetics Regulation. These substances are:
    • Disperse Violet 1 (entry n°265)
    • HC Red No 3 (entry n°266)
    • Basic Red 76 (entry n°267)
    • Basic Red 51 (entry n°268)
    • 2-Amino-5-Ethylphenol HCl (entry n°269)
    • Acid Red 92 (entry n°270)
    • Disperse Blue 377 (entry n°271)
    • p-Aminophenol (entry n°272)
    • Hydroxyethyl-4,5-Diamino Pyrazole
    • Sulfate (entry n°273)
    • 4-Formyl-1-Methylquinolinium-p-Toluene-sulfonate (entry n°274)
    • Basic Yellow 87 (entry n°275)
    • Basic Orange 31 (entry n°276)
    • 2,6-Diamino-3-((Pyridine-3-yl)azo)
    • Pyridine (entry n°277)
    • Basic Violet 2 (entry n°278)
    • 2,3- Diaminodihydropyrazolopyrazolone Dimethosulfonate (entry n°279)
    • Picramic Acid and Sodium Picramate (entry n°280)
    • Nitro-5-Glyceryl Methylaniline (entry n°281)
    • HC Blue 16 (entry n°282)
    • 5-Amino-6-Chloro-o-Cresol (entry n°283)
    • 2,2’-Methylenebis-4-aminophenol HCl (entry n°284)
    • 2,6-Diaminopyridine (entry n°285)

  2. Change The Maximum Authorised Concentrations In The Finished Product for - Toluene-2,5-Diamine and sulfate (entry n°9a) - by regulating it in Annex III of the Cosmetics Regulation

  3. Authorise 10 Hair Dye Substances And Hydrogen Peroxide - for use in products intended for colouring eyelashes - by setting up strict use conditions and obligatory warnings (such as „for professional use only“) in Annex III. The 10 substances are:
    • p-Phenylenediamine and sulfate (entry n°8b)
    • Hydrogen peroxide (entry n°12)
    • Resorcinol (entry n°22)
    • 6-Methoxy-2-Methylamino-3-Aminopyridine HCl (entry n°203)
    • m-Aminophenol HCL and sulfate (entry n°217)
    • 2-Methyl-5-Hydroxyethyl Aminophenol (entry n°229)
    • 4-Amino-2-Hydroxy-toluene (entry n°241)
    • 2,4-Diaminophenoxyethanol HCl and sulfate (entry n°242)
    • 4-Amino-m-Cresol (entry n°244)
    • 2-Amino-4- Hydroxyethylaminoanisole and Sulfate (entry n°245)

Implementation Timetable

The provisions with regards to the authorisation of 10 dyes and hydrogen peroxide in eyelash colouring products have entered into force on November 27, 2013, while the restrictions for the aforementioned hair dyes and obligatory labelling requirements for eyelash colouring products will apply from July 1, 2014.

This new Regulation (EU) No 1197/2013 is binding in its entirety and is directly applicable in all EU Member States.

Ensure Product Safety And Maintain Consumer Trust With SGS

It is crucial for all cosmetic and personal care products to be safe, effective and stable. SGS provides testing (physicochemical, microbiological, stability, toxicological and performance), inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area.

To ensure all ingredients used meet the chemical restrictions and limitations of applicable cosmetic regulations and other EU relevant legislations, SGS performs chemical tests on oxidative hair dye substances using HPLC-MS equipment.

In a highly competitive sector, where consumer safety is paramount, the industry must ensure that product efficacy claims are supported by scientific evidence. Partner with SGS to access market leading performance tests for hair colour products (colour fading - mechanical & light), as well as for volumising (Shadow Method), antidandruff, combability of wet and dry hair, hair colour curling/preserving hair loops, smoothing and rinsing.

Our consumer panel testing can provide a product assessment, as well as information about client behaviour, opinion and purchasing intentions. It also offers insight into market positioning and consumer preference, including verification of a product’s organoleptic criteria (touch, smell, appearance, etc.). Panels can comprise naïve or expert participants, with tests co-ordinated by a cosmetics expert and conducted either in-house or by a third party.

For more information please contact your local SGS representative or our global team: consumer.products@sgs.com and visit our website at: www.sgs.com/cosmetics.

Hubert Brundu
Global Technical Manager – Cosmetics
Personal Care and Household
SGS France
t: +33 4 42 61 64 91

Legislation References

Regulation 1197/2013/EU amending Annex III to cosmetic regulation (EC) No 1223/2009
Regulation (EC) No 1223/2009 on cosmetic products