Phenoxyethanol, o-Phenylphenol, Polyaminopropyl Biguanide, Cyclopentasiloxane, Formaldehyde, Eyelashes dyes, Acid Orange 7… The SCCS has just received seven requests for scientific Opinions. Details.
Phenoxyethanol (CAS: 122-99-6) as preservative is regulated in Annex V/29 of the Cosmetics Regulation 1223/2009.
According to the Cosmetics Regulation, Phenoxyethanol is authorized as a preservative in cosmetic formulations at a maximum concentration of 1.0%.
In September 2012, the Commission received a risk assessment submitted by the French Agency ANSM (Agence nationale de sécurité des médicaments et des produits de santé) which rose concerns about the use of Phenoxyethanol as preservative in cosmetic products.
The ANSM report (Evaluation du risque lié à l'utilisation du phénoxyéthanol dans les produits cosmétiques) concludes that the maximum authorized concentration (currently of 1%) of Phenoxyethanol for use as a preservative should be lowered to 0.4% in cosmetic products for children less than three years.
In addition, Phenoxyethanol should not be used in cosmetic products intended for their nappy area.
The Commission received information from other member States raising similar concerns on the use of Phenoxyethanol, in particular on children.
In December 2013, in response to a call for data on Phenoxyethanol by the Commission, Cosmetics Europe submitted a safety dossier in order to defend the current use of Phenoxyethanol as preservative in cosmetic formulations at a maximum concentration of 1.0%.
Questions to SCCS
1. Does SCCS consider Phenoxyethanol safe for use as preservative with a maximum concentration of 1.0%, taking into account the information provided?
2. The SCCS is asked, when making the assessment, to take into account the specific age groups who might be particularly susceptible to the effects of Phenoxyethanol used as preservatives in cosmetic products.
3. Does the SCCS have any further scientific concerns with regard to the use of Phenoxyethanol in cosmetic products?
• The full text of Request for a scientific opinion for the use of Phenoxyethanol CAS n. 122-99-6 as preservative
• The article Phenoxyethanol, o-Phenylphenol: Europe is looking for scientific data
• The article Phenoxyethanol: the French ANSM questions its safety for young children
o-Phenylphenol, Sodium o-phenylphenate, Potassium o-phenylphenate, MEA o-Phenylphenate
b-Phenyl-2-ol and its salts, covering o-Phenylphenol, Sodium o-phenylphenate, Potassium o-phenylphenate, MEA o-Phenylphenate (CAS: 90-43-7, 132-27-4, 13707-65-8, 84145-04-0) as preservatives are regulated in Annex V, entry 7 of the Cosmetics Regulation 1223/2009 at a maximum concentration of 0.2% (as phenol).
In February 2013, the Commission received a risk assessment submitted by the French Agency ANSM (Agence nationale de sécurité des médicaments et des produits de santé) which rose concerns about the use of o-Phenylphenol as preservative in cosmetic products.
In the ANSM report, o-Phenylphenol was identified as a potential endocrine disruptor. The report concluded that the maximum authorized concentration (currently of 0.2%) of o-Phenylphenol for use as a preservative should be revised due to a low margin of safety.
In January 2014, in response to a call for data on o-Phenylphenol by the Commission, Industry submitted a safety dossier to defend the current use of o-Phenylphenol, Sodium o-phenylphenate, Potassium o-phenylphenate as preservatives in cosmetic formulations at a maximum concentration of 0.2% (as phenol).
Questions to SCCS
1. Does SCCS consider o-Phenylphenol, Sodium o-phenylphenate, Potassium o-phenylphenate safe for use as preservatives with a maximum concentration of 0.2% (as phenol), taking into account the information provided?
2. Does SCCS consider that the same conclusion on the safety of o-Phenylphenol, Sodium o-phenylphenate, Potassium o-phenylphenate may be applicable to MEA o-Phenylphenate?
3. Does the SCCS have any further scientific concerns with regard to the use of o-Phenylphenol, in particular on its potential endocrine disruptor properties as raised in the ANSM report?
Polyaminopropyl Biguanide (PHMB)
Poly(hexamethylene) biguanide hydrochloride (PHMB) (CAS: 32289-58-0 or 27083-278 – INCI: Polyaminopropyl Biguanide), is authorized as preservative in cosmetic products at a maximum permitted concentration of 0.3%, according to Annex V of the Regulation 1223/2009.
Polyaminopropyl Biguanide (PHMB) is classified as CMR2 according to the Commission Regulation 944/2013 of 2 October 2013 amending for the purposes of its adaptation to technical and scientific progress the Regulation 1272/2008. In particular, in recital 7 of Commission Regulation 944/2013 it is reported that for PHMB the specific hazard 'acute toxicity (inhalation)' is under evaluation by the Committee for Risk Assessment (RAC). The classification will apply from 1st January 2015. As a consequence, PHMB would be prohibited from 1st January 2015 as cosmetic ingredient according to art. 15(1) of Regulation 1223/2009 on cosmetic products.
However, article 15 (1) of Regulation 1223/2009 states that 'a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation'.
In January 2014, the Commission received a submission from Cosmetics Europe4 on PHMB, intended to demonstrate the safety of the ingredient when used as a preservative in cosmetics products up to a maximum concentration of 0.3%.
Questions to SCCS
1. In view of the above, and taking into account the scientific data provided, SCCS is requested to give its opinion on the safety of Polyaminopropyl Biguanide (PHMB) when used as a preservative in cosmetics products up to a maximum concentration of 0.3%.
2. SCCS is requested to address any further scientific concerns on the ingredient Polyaminopropyl Biguanide (PHMB) in particular regarding its use in spray formulation.
Deadline : July 2014.
• The full text of Request for a scientific opinion: Polyaminopropyl Biguanide (PHMB)
Cyclopentasiloxane (D5) (CAS: 541-02-6, EC: 208-764-9) is widely used in cosmetic products due to its unique functions as antistatic, emollient, humectant, solvent, viscosity controlling and hair conditioning agent.
In June 2010, the Scientific Committee for Consumer Safety (SCCS) assessed the consumers risks associated with the use of D5 in combination with its isomer D4 (Cyclomethicone, Octamethylcyclotetrasiloxane, CAS: 556-67-2), a substance that has been classified as a CMR 2 substance (Carc. 2) under Regulation 1272/2008. Being an old CMR (i.e. its classification applied before 1 December 2010), the regime of automatic ban as from the date of application of its classification, except where a derogation is granted, does not apply to this substance.
In its opinion (SCCS/1241/10), the SCCS concluded that:
"[…] cyclomethicone (D4, D5) does not pose a risk for human health when used in cosmetic products. Other uses were not considered in this risk assessment. This conclusion is based on the currently available in-use concentrations as cited in this opinion.
The Commission Services should consider whether an environmental risk assessment associated with the use of cyclomethicone (D4/D5) in cosmetic products is required."
Upon request of the European Commission, in January 2014 Cosmetic Europe submitted a safety assessment specifically dedicated to D5 in cosmetic products. This submission is intended to demonstrate the safety of this ingredient when used in cosmetic leave-on, rinse-off and spray type products.
Questions to SCCS
1. On the basis of the data provided does the Scientific Committee on Consumer Safety (SCCS) consider Cyclopentasiloxane (D5) safe as cosmetic ingredient?
2. Does the SCCS have any further scientific concerns in particular regarding the wide use of this ingredient in several cosmetic products and in different concentrations?
• The full text of Request for a scientific opinion: Cyclopentasiloxane (D5)
Formaldehyde in nail hardeners
The substance formaldehyde (CAS: 50-00-0) is anticipated to be classified as a carcinogen category 1B under the CLP Regulation 1272/2008, following a qualified majority in favor of the Committee opinion adopted on 17 December 2013. This classification shall apply by 1st April 2015.
Regulation 1223/2009 foresees that the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) substances, of category 1A or 1B, under Part 3 of Annex VI to the Regulation 1272/2008, is prohibited.
However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation 1272/2008, all of the conditions (hereafter reported) of Article 15.2 of the Cosmetics Regulation are fulfilled:
(a) they comply with the food safety requirements as defined in Regulation 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 matter of food safety;
(b) there are no suitable alternative substances available, as documented in an analysis of alternatives;
(c) the application is made for a particular use of the product category with a known exposure; and
(d) they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population subgroups.
The regulatory measures authorizing such exemption for use shall be adopted within 15 months of the classification as CMR 1A or 1B of the substance(s) concerned in Part 3 of Annex VI to Regulation 1272/2008.
Nail hardeners are very specialized cosmetics used to harden or strengthen natural nails, especially soft, brittle or fragile nails. Formaldehyde is used in nail hardeners for its specific cross-linking functionality with keratin. The use of formaldehyde in nail hardeners is currently restricted as specified in Annex III of the Cosmetics Regulation.
Additionally the use of formaldehyde (CAS 50-00-0) as preservative for cosmetics is also allowed under restricted conditions [Entry 5 of Annex V].
In July and November 2013, Cosmetics Europe representing an industry consortium, submitted a full application to support the use of formaldehyde in nail hardeners under the current conditions specified in Entry 13 of the Annex III of Regulation (EC) No 1223/2009 - i.e. a maximum concentration in the finished products of 5% (as formaldehyde); labelled as 'contains formaldehyde ' when the finished cosmetic product contains formaldehyde in a concentration above 0,05% and with the warning 'protect cuticles with grease or oil'.
The industry consortium considers that its application for exemption contains the data supporting the fulfilment of conditions a), b) and c) of Article 15.2. The application contains an evaluation of the toxicological profile of formaldehyde, a global human exposure assessment to formaldehyde and an assessment of the safety of free formaldehyde released by the usage of nail hardeners under the current conditions for use (see above).
The Commission published on 23 May 2013, a call for data on formaldehyde use in cosmetics and/or formaldehyde released by others substances used in cosmetics, seeking also information of the suitable alternatives. The Commission only received information from Cosmetics Europe that are included in the application submitted.
The Commission considered that the substantiation of the three first conditions of Article 15.2 are fulfilled, allowing that the SCCS proceeds now with its scientific assessment.
Questions to SCCS
In view of above, and taken into account the data provided in the application, and from other sources, SCCS is requested:
1) To assess if condition d) of Article 15.2 is fulfilled, in order to confirm or not the safe use of formaldehyde in nail hardeners under the current restricted conditions for use as specified in Annex III of Regulation 1223/2009.
2) To review as necessary the restriction's conditions set in Annex III - e.g. adding a maximum concentration of free formaldehyde of 2.2% as indicated in the application.
SCCS should convey its overall assessment in an opinion to be adopted as a matter of urgency.
Deadline : 1st June 2014.
• The full text of Request for a scientific opinion of the safety of the use of formaldehyde in nail hardeners
Oxidative hair dye substances and hydrogen peroxide in products to colour eyelashes (Addendum)
The definition of the term "hair product" was introduced in the preamble to Annexes II to VI of the Cosmetics Regulation 1223/20091. A "hair product" is defined as a cosmetic product which is intended to be applied on the hair of head or face, except eyelashes.
The application of the newly defined term "hair product" in conjunction with provisions relating to specific substances in the new Annex III to the EU Cosmetics Regulation will restrict the use of relevant substances. Moreover, it is no longer legally possible to market oxidative colouring agents for application to eyelashes in the EU from July 2013.
The safety data on each hair dye substance submitted for risk assessment by the SCCS in the framework of the assessment strategy contain mandatory data on eye irritation. Therefore, the safety of these substances with regard to the application in the eye area was or will be assessed in the overall evaluation of each individual hair dye substance.
The Scientific Committee on Consumer Safety (SCCS)
adopted the scientific opinion by written procedure
on 12 October 2012 (SCCS/1475/12) related to the use of oxidative hair dye substances and hydrogen peroxide for use in products to colour eyelashes with the following conclusion:
Information of eye irritation of oxidative dyes at or near anticipated use concentrations intended for eyelashes is available for only some of the dyes. For those tested at such concentrations there was either no or slight irritant potential and their use is considered safe in permanent eyelash dye formulations intended for the consumer. Dyes tested at higher concentration which were found to be not or slightly irritant can be considered safe.
It is unknown what the irritant potential is of those dyes which have not been tested at use concentrations but which are irritant at the concentrations tested. For these substances appropriate information is required before they can be assessed.
For those hair dyes substances for which there is information on eye irritation at anticipated dilutions and were found to have no or slight effects, there is no concern about eye irritation in the consumer.
For those hair dyes substances for which there is no information on eye irritant potential at anticipated dilutions, it is not possible to draw a conclusion without additional information on eye irritant potential at anticipated use concentrations.
For those dyes which are skin sensitizers, there is a risk of allergic contact dermatitis developing in previously sensitised individuals.
No detailed information is available on the ocular irritant properties of permanent eyelash dyes formulations intended for the consumer and these formulations need to be assessed on a case by case basis by the supplier.
In December 2013 the Commission received the attached submission by Cosmetics Europe. According to the applicant the document contains the requested information for six out of the ten dyes and the selection reflects the commercial interest of companies who funded the studies.
Questions to SCCS
1. Does SCCS consider the submitted safety data, in particular the data provided on eye irritation, sufficient to conclude that oxidative hair dyes which were found safe for use in hair dye products can be safely used in products to colour eyelashes?
2. And/or does the SCCS have any further scientific concerns with regard to the use of the oxidative hair dyes (the ones related to the submitted data) intended to colour eyelashes (e.g. max conc. in the finish cosmetic product, warning)?
• The full text of Request for an Addendum to the scientific opinion on the safety of oxidative hair dye substances and hydrogen peroxide in products to colour eyelashes
Acid Orange 7
Submission I and II for the hair dye Acid Orange 7 with the chemical name Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzene sulfonate (CAS: 633-96-5, EC: 211-199-0) were transmitted in September 2003 and July 2005 respectively by Cosmetics Europe.
Acid Orange 7 is identical with CI 15510 also used as a colouring agent “allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover”.
According to Submission II Acid Orange 7 is a non-reactive dye, used as direct hair colouring agent up to an on-head concentration of 0.5% in non-oxidative as well as in oxidative hair dye formulations. Following Submission II, in March 2011 the Scientific Committee for Consumer Safety (SCCS) concluded that:
"Based on the low margin of safety, the SCCS is of the opinion that the use of Acid Orange 7 as a hair dye ingredient up to a final on-head concentration of 0.5% under oxidative and non-oxidative conditions poses a risk to the health of the consumer.
No dermal absorption study was performed under oxidative conditions. No data on the stability in an oxidative environment has been provided.
The safety of the use of Acid Orange 7 (CI 15510) as a cosmetic colorant should be assessed."
Based on these conclusions, in February and July 2013 Cosmetics Europe has transmitted new data (Submission III) to clarify some analytical aspects and a new study on dermal absorption to provide clarification on the evaluation of Systemic Exposure Dose to Acid Orange 7 at 0.5% and 0.8% under non-oxidative and oxidative conditions respectively. In addition, Procter & Gamble has transmitted an in vitro study to assess the dermal absorption of Acid Orange 7 under similar use conditions.
Questions to SCCS
1. In light of the new data provided, does the SCCS consider Acid Orange 7 (C015) safe at on-head concentrations up to 0.5% under non-oxidative conditions?
2. Does the SCCS consider Acid Orange 7 (C015) safe at on-head concentrations up to 0.8% under oxidative conditions? If not, does the SCCS suggest maximum concentrations under oxidative and non-oxidative conditions for which Acid Orange 7 (C015) could be considered safe for consumers?
3. Does the SCCS have any further scientific concerns with regard to the use of Acid Orange 7 (C015) in cosmetic products particularly as it is used as colorant agent with the name of CI 15510?
• The full text of Request for a scientific opinion: Submission III on Acid Orange 7 (C015)