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Public Health
  • News announcement
  • 26 June 2015
  • Directorate-General for Health and Food Safety
  • 136 min read

SCCS - Opinion on Decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic products - Commenting period extended until 20 August 2015 at the latest

SCCS - Opinion on Decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic products - Commenting period extended until 20 August 2015 at the latest

Preliminary Opinions open for comments

The preliminary Opinions in this section have been developed by the SCCS on the basis of specific sets of data (dossiers) submitted by specific Applicants (e.g. Industry, Member State authorities, etc.) in order to satisfy specific regulatory requirements.

These preliminary Opinions have been recently approved and are now open for clarification/comment for a minimum period of 4 weeks (if possible, for a period of eight weeks). The exact timeline is given for each Opinion.

This publication intends to enable Applicants, but also other interested parties, to provide clarification/comment, if any, about the evaluation, interpretation, and incorporation of the submitted set of data in the SCCS preliminary Opinion.

Please note that this is NOT a public consultation process whereby new evidence or comments on the scientific basis of the preliminary Opinion are submitted for consideration in order to finalise the Opinion, nor is it an opportunity for the Applicant concerned to submit a totally new set of data that would lead to a new submission and mandate.

Clarifications/comments should preferably be numbered, clearly referring to specific sections of the Preliminary Opinion (to be indicated) and sent to the following mailbox only: SANTE-C2-SCCS AT ec.europa.eu

The clarifications/comments received during the commenting period will be forwarded to the SCCS for consideration.

  • Kojic acid Abstract

    SCCS/1637/21 - 26-27 October 2021
    Deadline for comments: 14 January 2022

    Kojic acid

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1637/21
    Adopted on: 26-27 October 2021


    Conclusion of the opinion:

    (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Kojic acid, does the SCCS consider Kojic acid safe when used in cosmetic products up to a maximum concentration of 1 %?

    On the basis of the safety assessment, and considering the concerns related to potential endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that the concentration of 1% Kojic acid is not safe for the intended use in cosmetic products.

    (2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Kojic acid in cosmetic products?

    Without specific data on the different cosmetic products containing Kojic acid, the SCCS is unable to advice on the safe concentration of Kojic acid in individual cosmetic products. As an example, for the combined twice a day use of face cream and hand cream, the maximum concentration of Kojic acid should not exceed 0.04%.

    (3) Does the SCCS have any further scientific concerns with regard to the use of Kojic acid in cosmetic products?

    As Kojic acid is sometimes added to peeling agents, a weakened skin barrier may be of additional concern because of greater dermal absorption.

    Only the topical use of Kojic acid in cosmetics has been considered in this Opinion. Other uses (e.g. food) of natural or synthetic sources have not been considered.

    As far as the derivatives of Kojic acid are concerned, e.g. esters of Kojic acid such as Kojic acid dipalmitate and Kojic acid isopalmitate, and derivatives such as chloro-Kojic acid, these have not been included in this Opinion as no data has been submitted.


    Keywords:

    SCCS, revision, scientific opinion, Kojic acid, CAS No 501-30-4, EC No 207-922-4, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), scientific opinion on Kojic acid, preliminary version of 26-27 October 2021, SCCS/1637/21.


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Opinions being finalised

The commenting period for the Opinions in this section has expired. Comments received during this period have been submitted to SCCS and will be discussed in the forthcoming working groups and plenary meetings with the view to finalising the Opinions.

  • Prostaglandins and prostaglandin-analogues used in cosmetic products Abstract

    SCCS/1635/21 - 27 September 2021

    Prostaglandins and prostaglandin-analogues used in cosmetic products

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik (Rapporteur), T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1635/21
    Adopted on: 27 September 2021


    Conclusion of the opinion:

    (1) In light of the data provided, does the SCCS consider Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide or DDDE (CAS 1185851-52-8) safe when used up to the concentrations provided in the respective dossiers (0.006% and 0.007% for Isopropyl cloprostenate and 0.018% for Ethyl Tafluprostamide)

    Having considered the limited data provided, and the available information from published literature, the SCCS is not able to conclude on the safety of isopropyl cloprostenate and ethyl tafluprostamide, when used up to the intended use concentrations indicated in the respective dossiers (0.006% and 0.007% for isopropyl cloprostenate and 0.018% for ethyl tafluprostamide).

    (2) Does the SCCS have any further scientific concerns with regard to the use of Isopropyl cloprostenate (CAS 157283-66-4) and Ethyl Tafluprostamide / DDDE (CAS 1185851-52-8) in cosmetic products?

    The SCCS has noted serious concerns about the safety of isopropyl cloprostenate and ethyl tafluprostamide when used in cosmetic products - in particular those that are intended for use in the proximity of the eye. These concerns have been highlighted in more details in Annex 1.

    (3) In light of the available data, does the SCCS consider that the use in cosmetic products of prostaglandins analogues (listed in Table 1) raises safety concerns and might pose a risk to human health?

    Prostaglandins and synthetic analogues are widely known to be potent pharmacologically active substances. Due to these effects, other regulatory authorities have advised against, or have prohibited, their use in eyelash growth-promoting cosmetics. In view of the potential for causing effects at very low concentrations, and the intended use in the proximity of the eye, the SCCS has noted serious concerns over the safety of prostaglandin analogues when used in cosmetic products. These have been highlighted in Annex 1 to this Opinion.


    Keywords:

    SCCS, scientific opinion, prostaglandins, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Prostaglandins and prostaglandin-analogues used in cosmetic products, preliminary version of 27 September 2021, SCCS/1635/21.


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  • Butylated Hydroxytoluene (BHT) Abstract

    SCCS/1636/21 - 27 September 2021

    Butylated Hydroxytoluene (BHT)

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1636/21
    Adopted on: 27 September 2021


    Conclusion of the opinion:

    (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of BHT (Butylated hydroxytoluene), does the SCCS consider BHT safe:

    (a) when used in mouthwash up to the maximum concentration of 0.001% and in toothpaste up to the maximum concentration of 0.1% ?

    On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of BHT, the SCCS is of the opinion that BHT is safe as an ingredient up to a maximum concentration of 0.001% in mouthwash and 0.1% in toothpaste.

    (b) when used in other leave on and rinse-off products up to a maximum concentration of 0.8 % ?

    On the basis of a safety assessment, and considering the concerns related to potential endocrine disrupting properties of BHT, the SCCS is of the opinion that BHT is safe as an ingredient up to a maximum concentration of 0.8% in other leave-on and rinse-off products.

    BHT is also considered safe for a combined use of mouthwash at a concentration of 0.001%, toothpaste at a concentration of 0.1% and other leave-on and rinse-off products at the concentration of 0.8%.

    (2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of BHT (Butylated hydroxytoluene) in cosmetic products?

    /

    (3) Does the SCCS have any further scientific concerns with regard to the use of BHT (Butylated hydroxytoluene) in cosmetic products?

    The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of BHT for the environment.


    Keywords:

    SCCS, scientific opinion, Butylated hydroxytoluene (BHT), CAS No 128-37-0, EC No 204-881-4, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), scientific opinion on Butylated hydroxytoluene (BHT), preliminary version of 27 September 2021, SCCS/1636/21.


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Final Opinions

The Opinions in this section have been finalised and adopted by the SCCS. New evidence is required before considering revising an existing Opinion.

Nanomaterials

  • HAA299 (nano) Abstract

    SCCS/1634/21 - 26-27 October 2021

    HAA299 (nano)

    Link to opinion

    SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri (Rapporteur), Ch. Rousselle, M. Stepnik, S. Wijnhoven
    SCHEER members: W.H. de Jong
    SCCS external experts: N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1634/21
    Adopted on: 26-27 October 2021


    Conclusion of the opinion:

    (1) In light of the data provided, does the SCCS consider HAA299 (nano) safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10%?

    The available data indicate that HAA299 (nano) is a practically insoluble material, with very low dermal and oral absorption. Due to the very low systemic availability, the material is unlikely to exert systemic genotoxic or reproductive effects. The NOAEL of 1000 mg/kg/day indicates that the material is of overall low toxicological concern. Given the low dermal penetration, and low systemic toxicity, the calculation of margin of safety (MoS) is not appropriate in this case. The SCCS considers that HAA299 (nano) as covered within the provided characteristics (minimum purity equal to or above 97%, median particle size in terms of particle number equal to or above 50 nm) is safe when used as a UV-filter in dermally-applied cosmetic products up to a maximum concentration of 10%.

    Based on the inflammatory effects on the lung after the acute inhalation exposure, the SCCS has concerns regarding the repeated use of products containing HAA299 (nano) in applications that could lead to inhalation exposure. Therefore, the SCCS does not recommend the use of HAA299 (nano) in applications that could lead to exposure of the consumer’s lungs via inhalation.

    (2) In view of the previous SCCS opinion (SCCS/1533/14) does the SCCS consider HAA299 non-nano and nano form safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10%?

    The data considered in this Opinion has not provided any new or additional concern that merits a revision of the previous SCCS opinion (SCCS/1533/14). Therefore, the SCCS considers HAA299, either as non-nano or nano form, safe when used as a UV-filter in dermally-applied cosmetic products up to a maximum concentration of 10%. The SCCS considers that the combined maximum concentration of non-nano and nano forms of HAA299 should not exceed 10% in a cosmetic product.

    (3) In case the SCCS finds HAA299 (nano) not safe, does it still uphold the conclusions of the SCCS/1533/14 opinion with regard to the safe use of HAA299 non-nano form?

    /

    (4) Does the SCCS have any further scientific concerns (on human health) with regard to the use of HAA299 (nano) in cosmetic products?

    This opinion is based on the currently available scientific evidence, which shows an overall very low or lack of dermal absorption of HAA299 (nano) in human skin. If any new evidence emerges in the future to show that HAA299 (nano) used as UV-filter in cosmetic products can penetrate human skin (healthy, compromised, sunburnt or damaged skin) to reach viable cells in higher levels than demonstrated in this submission, then the SCCS may consider revising this assessment.


    Keywords:

    SCCS, scientific opinion, HAA299, nano, CAS 919803-06-8, EC No. 485-100-6, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on HAA299 (nano), preliminary opinion 22 July 2021, final opinion 26-27 October 2021, SCCS/1634/2021.


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  • Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano) Abstract

    SCCS/1630/21 - 24-25 June 2021

    Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano)

    Link to opinion

    SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven (Rapporteur)
    SCHEER members: W.H. de Jong
    SCCS external experts: N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1630/21
    Adopted on: 24-25 June 2021


    Conclusion of the opinion:

    (1) In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials A (Platinum and Colloidal Platinum ) and B (Acetyl tetrapeptide-17 (and) Colloidal Platinum) are safe when used in leave-on cosmetic products according to the maximum concentrations and specifications reported in the attached list, taking into account reasonably foreseeable exposure conditions?

    Having considered all the information provided by the Notifiers, and that obtained from other sources, the SCCS is of the opinion that it is not possible to carry out a safety assessment of any of the notified platinum nanomaterials due to limited or missing essential information. The limited amount of data provided by the Notifiers also does not correspond to the requirements and data standards as indicated in the SCCS Guidance (SCCS 1611/19), and the SCCS Memorandum (SCCS/1524/13).

    To enable safety assessment by the SCCS, the Notifiers need to provide the necessary information, a summary of which is provided in Annex I.

    (2) Does the SCCS have any further scientific concerns with regard to the use of materials A and B in nano form in cosmetic products?

    In the absence of sufficient data to allow safety assessment, the SCCS has considered the different aspects of platinum nanomaterials that could raise a concern over consumer safety. As detailed in Annex II, the SCCS has concluded that there is a basis for concern that the use of platinum, colloidal platinum, and acetyl tetrapeptide-17 colloidal platinum (nano) in cosmetic products can pose a risk to the consumer. The SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.


    Keywords:

    SCCS, scientific opinion, Platinum, Colloidal Platinum, Acetyl tetrapeptide-17 Colloidal Platinum, nano, CAS No 7440-06-4, EC No. 231-116-1, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano), final version of 24-25 June 2021, SCCS/1630/21.


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  • Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano) Abstract

    SCCS/1629/21 - 24-25 June 2021

    Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano)

    Link to opinion

    SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet (Rapporteur), E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven
    SCHEER members: W.H. de Jong
    SCCS external experts: N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1629/21
    Adopted on: 24-25 June 2021


    Conclusion of the opinion:

    1. In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials Gold and Colloidal Gold, Gold Thioethylamino Hyaluronic Acid and Acetyl heptapeptide-9 Colloidal gold are safe when used in leave-on skin cosmetic products according to the maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions?

    The SCCS has considered all the information provided by the Notifiers and is of the opinion that it is not possible to carry out safety assessment of the nanomaterials (Gold, Colloidal Gold and Surface Modified Gold) due to limited or missing essential information. Much of the information provided on toxicity relates to gold as such, and it is not possible to determine the relevance of the data for nano-forms of any of the materials under the current evaluation due to the absence of full study reports.

    Detailed data and information need to be provided on physicochemical characterisation and toxicological evaluation, along with experiment performance to allow safety assessment of the nanomaterials.

    In regard to surface modified gold, all notifications relating to Acetyl heptapeptide-9 Colloidal gold (nano) were withdrawn by the Notifiers and therefore only Gold Thioethylamino Hyaluronic Acid has been considered in this Opinion.

    2. Does the SCCS have any further scientific concerns with regard to the use of materials A, B and C in nano form in cosmetic products?

    The information obtained from scientific literature suggests possible systemic uptake of gold nanoparticles which may lead to accumulation in certain organs - notably the liver and spleen. In addition, the available data from literature indicate potential mutagenic/genotoxic effects of gold nanomaterials. These indications raise an alert that warrants further safety evaluation of gold nanomaterials when used as cosmetic ingredients. In the absence of sufficient data to allow safety assessment, the SCCS has considered these aspects and has concluded that there is a basis for concern that the use of Gold (nano), Colloidal Gold (nano) and Surface Modified Gold (nano) materials in cosmetic products can pose a risk to the consumer. The SCCS concerns for consumer safety in this regard are detailed in Annex II. The SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.


    Keywords:

    SCCS, scientific opinion, gold, colloidal gold, Gold Thioethylamino Hyaluronic Acid, Acetyl heptapeptide-9 Colloidal gold, nano, CAS No 7440-57-5, EC No. 231-165-9, CAS No. 1360157-34-1, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano), final version of 24-25 June 2021, SCCS/1629/2021.


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  • Hydroxyapatite (nano) Abstract

    SCCS/1624/20 - 30-31 March 2021

    Hydroxyapatite (nano)

    Link to opinion

    SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle (Rapporteur), M. Stepnik, S. Wijnhoven
    SCHEER member: W.H. de Jong
    SCCS external expert: N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1624/20
    Adopted on: 30-31 March 2021


    Conclusion of the opinion:

    (1) In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterial Hydroxyapatite safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the maximum concentrations and specifications reported in the attached list, taking into account reasonably foreseeable exposure conditions?

    Having considered the data provided, and other relevant information available in scientific literature, the SCCS cannot conclude on the safety of the hydroxyapatite composed of rod–shaped nanoparticles for use in oral-care cosmetic products at the maximum concentrations and specifications given in this Opinion. This is because the available data/information is not sufficient to exclude concerns over the genotoxic potential of HAP-nano.

    (2) Does the SCCS have any further scientific concerns with regard to the use of Hydroxyapatite in nano form in cosmetic products?

    Although the particle shape in the HAP-nano considered in this Opinion is reported as rod-shaped, the SCCS is aware that, depending on the manufacturing process, needle-shaped HAP nanoparticles may also be produced. The available information indicates that HAP-nano in needle-shaped form is of concern in relation to potential toxicity. Therefore, needle-shaped HAP-nano should not be used in cosmetic products.

    As detailed in Annex I, the SCCS has concluded that there is a basis for concern that the use of HAP-nano in cosmetic products can pose a risk to the consumer. The SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.


    Keywords:

    SCCS, scientific opinion, Hydroxyapatite (nano), CAS No 1306-06-5, EC No. 215-145-20, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Hydroxyapatite (nano), preliminary version of 27-28 October 2020, final version of 30-31 March 2021, SCCS/1624/2020.


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  • Copper (nano) and Colloidal Copper (nano) Abstract

    SCCS/1621/20 - 5 March 2021

    Copper (nano) and Colloidal Copper (nano)

    Link to opinion

    SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven
    SCHEER member: W.H. de Jong (Rapporteur)
    SCCS external expert: N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1621/20
    Adopted on: 5 March 2021


    Conclusion of the opinion:

    1. In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials Copper and Colloidal Copper safe when used in leave-on and rinse-off dermal and oral cosmetic products including: skin, nail and cuticle, hair and scalp and oral hygiene products, at a maximum concentration of 1 % (for both Copper and Colloidal Copper) and with specifications as reported in the attached list, taking into account reasonably foreseeable exposure conditions?

    The SCCS has considered all the information provided by the Notifiers and is of the opinion that it is not possible to carry out safety assessment of the nanomaterials Copper and Colloidal Copper due to the limited or missing essential information.
    Much of the information provided on toxicity relates to copper as such, and in the absence of full study reports, it is not possible to determine the relevance of the data for nano-forms of copper under the current evaluation.
    Adequate information on various aspects both for the nanomaterial characterisation and the toxicological evaluation including experiment performance and experimental data obtained need to be provided (as summarised in Annex I).

    2. Does the SCCS have any further scientific concerns with regard to the use of Copper and Colloidal Copper in nano form in cosmetic products?

    The information provided by the Notifiers, and obtained from scientific literature, suggests possible systemic uptake of Cu nanoparticle (and/or ionic Cu), which may lead to accumulation in certain organs - notably the liver and spleen. In addition, the available literature data indicate potential mutagenic/genotoxic and immunotoxic/nephrotoxic effects of copper nanomaterials. These indications raise an alert that warrants further safety evaluation of copper nanomaterials used as cosmetic ingredients. The SCCS concerns for consumer safety in this regard are detailed in Annex II.
    Annex I provides an overview of the information provided by the Notifiers compared to the data requirements as given in the SCCS checklists for Applicants submitting dossiers on Cosmetic Ingredients to be evaluated by the SCCS (SCCS/1588/17).


    Keywords:

    SCCS, scientific opinion, Copper (nano), Colloidal Copper (nano), CAS No 7440-50-8, EC No. 231-159-6, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Copper (nano) and Colloidal Copper (nano), preliminary version of 27-28 October 2020, final version of 5 March 2021, SCCS/1621/2020.


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  • Scientific Advice on the safety of nanomaterials in cosmetics Abstract

    SCCS/1618/20 - 8 January 2021
    Corrigendum of 8 March 2021 was done in the table of Annex I. Column 4 (Already assessed by the SCCS) was updated with the SCCS opinion numbers.

    Scientific Advice on the safety of nanomaterials in cosmetics

    Link to opinion

    WG on Nanomaterials in Cosmetic Products
    SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry (Rapporteur), P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven
    SCHEER member: W.H. de Jong
    SCCS external expert: N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1618/20
    Adopted on: 8 January 2021


    Conclusion of the opinion:

    1. The SCCS is requested to determine the nanomaterials, as published in the recent catalogue of nanomaterials of 2019, for which specific concerns can be identified and justified in order to establish a priority list of nanomaterials for risk assessment (Article 16(4) Reg.1223/2009). More specifically, the SCCS is requested to provide a description of the specific concerns that have been identified for the nanomaterials mentioned above. This process should be based on the currently available scientific literature and SCCS’ expert judgement.*

    Through a review of the available information and expert judgment, the SCCS has identified certain aspects of nanomaterials that constitute a basis for concern over safety to consumers’ health when used in cosmetic products. These include:
    - Physicochemical aspects relating to: very small dimensions of the constituent particles; solubility/persistence; chemical nature and toxicity of the nanomaterial; physical/morphological features of the constituent particles; surface chemistry and surface characteristics (surface modifications/coatings);
    - Exposure aspects relating to: the frequency and the amounts used, whether the number/type of consumer product(s) used is relatively high; and whether there is a potential for systemic exposure of the consumer to nanoparticles and potential accumulation in the body;
    - Other aspects relating to: novel properties, activity or function, and specific concern arising from the type of application.

    A detailed account of these aspects has been presented in this Advice. Also, the nanomaterials listed in the EC catalogue of nanomaterials of 2019 have been tabulated in an order of priority according to risk potential in Annex 1 of this Advice.

    2. For the nanomaterials with inconclusive SCCS opinions, such as [Colloidal Silver (nano) (SCCS/1596/18), Styrene/Acrylates copolymer (nano) + Sodium styrene/Acrylates copolymer (nano) (SCCS/1595/18) and Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form) (SCCS/1545/15)], the SCCS is requested to assess if a potential risk can be identified according to Article 16(6) Reg. 1223/2009. Such assessment, regardless of the data previously submitted by the respective applicants, should be based on the available scientific literature and SCCS’ expert judgement (i.e. systemic or local availability; harmful effects specifically related to nano-form; surface catalysed reactions in nano-form, absorption (or potential absorption) from dermal and inhalation routes, potential of nano-form to deliver ionic forms, etc.).*

    The SCCS has reviewed previous inconclusive opinions on three nanomaterials (SCCS/1596/18; SCCS/1595/18 and SCCS/1545/15), in conjunction with any further relevant information available in published literature to identify whether there is a scientific basis for concern over their safety to consumers’ health when used in cosmetic products. The SCCS has identified certain aspects relating to each of the nanomaterials that raise a safety concern. These have been detailed in three separate annexes (2, 3 and 4) to this Advice.

    * In the assessment of the above question and in order to avoid conflicting opinions with other bodies, SCCS is invited to consult SCHEER.


    Keywords:

    SCCS, scientific advice, safety, nanomaterials, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Scientific advice on the safety of nanomaterials in cosmetics, preliminary version of 6 October 2020, final version of 8 January 2021, SCCS/1618/2020.


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  • Solubility of Synthetic Amorphous Silica (SAS)Abstract

    SCCS/1606/19 - 20-21 June 2019
    Corrigendum of 6 December 2019

    Solubility of Synthetic Amorphous Silica (SAS)

    Link to opinion

    WG on Nanomaterial in Cosmetic Products
    SCCS members: U. Bernauer (Chairperson), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet (Rapporteur), E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven
    SCHEER members: W.H. de Jong
    SCCS external experts: N. von Götz, A. Simonnard
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1606/19
    Adopted on: 20-21 June 2019


    Conclusion of the opinion:

    1. Does the SCCS consider that Synthetic Amorphous Silica (SAS) are soluble (100 mg/L or higher) or degradable/non-persistent in biological systems, in light of the nanomaterial definition of the Cosmetic Regulation?

    Having considered the data provided in this dossier and that available in published literature, the SCCS concludes that:

    i) the solubility values for hydrophilic SAS materials have been reported to range from 22 mg/L to 225 mg/L for the solubility tests performed in aqueous media following the OECD TG 105 protocol or the Enhanced OECD TG 105 protocol. The latter protocol has been noted to increase the solubility by a factor of 10 for some hydrophilic SAS materials.

    ii) the solubility values of hydrophobic surface-treated SAS materials have been reported to range from 0.4 to 180 mg/L for solubility tests performed in aqueous media following the OECD TG 105 or following a modified Enhanced OECD TG 105 protocol (i.e. using 10% ethanol). The latter protocol has been noted to strongly increase the solubility of some hydrophobic SAS materials (by a factor up to 173).

    The hydrophilic and hydrophobic SAS materials can therefore be regarded as “insoluble” (i.e. below 100 mg/L) to “very slightly soluble” (i.e. 100 mg/L to 1000 mg/L) by the SCCS based upon the terminology used in USP38 and USP 38 NF33 (Table 1 corrected by the SCCS).

    In regard to the nanomaterial definition in the Cosmetic Regulation, none of the SAS materials (hydrophilic or hydrophobic) included in the dossier can be regarded as soluble. In fact, the Applicant had mistakenly interpreted the SAS materials as soluble on the basis of the solubility of some of the materials being 100 mg/L or higher. The threshold for regarding a material 'soluble' is 33.3 g/L under the USP38 and USP 38 NF33 categorisation (not 100 mg/L as claimed by the Applicant).

    No data were provided to help establish whether the SAS materials could be regarded degradable/non-persistent in biological systems.

    2. Can the SCCS indicate to which kind of Silica this solubility applies?

    The solubility values reported in the dossier are applicable when SAS materials are subject to the following conditions:

    - hydrophilic SAS: Silica and hydrated silica when solubilised in aqueous media,
    - hydrophobic surface treated SAS: when solubilised in aqueous media containing up to 10% ethanol,
    - at temperatures between 19.5 to 20.5°C,
    - with a pH level of between 3 and 8,
    - over a period between 3 days (hydrophilic SAS) up to 49 days (hydrophobic SAS).

    3. Does the SCCS have any further scientific concerns with regard to solubility of Synthetic Amorphous Silica (SAS)?

    - The solubility values considered by the SCCS in this Opinion may not be valid in situations where the SAS materials are formulated/used under conditions that are different from those used in the solubility tests - e.g. when used in a less/non aqueous formulation, or at a different temperature.

    - In the context of the definition of nanomaterial under the Cosmetics Regulation, which relates to insoluble materials in conjunction with other size/particle related parameters, the question of solubility of a nano-structured material needs to be seen in perspective for use in cosmetics. For nano-structured materials, with the exception of the materials that are completely soluble, it is important to establish whether a proportion of these materials would still exist in undissolved form comprising nanoparticles, at the given use level in a cosmetic formulation.

    - The SCC has noted that the protocols used for solubility tests have a strong influence on the solubility of SAS materials.


    Keywords:

    SCCS, scientific opinion, Synthetic Amorphous Silica (SAS), solubility, nanomaterials, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on solubility of Synthetic Amorphous Silica (SAS), 20-21 June 2019, SCCS/1606/2019. Corrigendum of 6 December 2019.


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  • Colloidal Silver (nano) Abstract

    SCCS/1596/18 - 24-25 October 2018

    Colloidal Silver (nano)

    Link to opinion

    WG on Nanomaterials in Cosmetics
    SCCS members: U. Bernauer (Chair), L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven (Rapporteur)
    SCHEER members: P.H.M. Hoet, W.H. de Jong
    SCCS external experts: N. von Götz, A. Simonnard
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1596/18
    Adopted on: 24-25 October 2018


    Conclusion of the opinion:

    1. In view of above, and taken into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterial Colloidal Silver when used in cosmetics including toothpastes and skin care products with a maximum concentration limit of 1%, taking into account the reasonably foreseeable exposure conditions.

    Only a limited amount of data was provided by the Applicants that corresponded to the SCCS Guidance on Safety Assessment of Nanomaterials in Cosmetics (SCCS 1484/12). The provided data were also not in line with the SCCS Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials (SCCS/1524/13). Although other information is available in open literature relating to the toxicity of nano silver, their relevance with respect to the materials in this submission has not been considered by the Applicants. Due to a number of major data gaps, the SCCS is not in the position to draw a conclusion on the safety of colloidal silver in nano form when used in oral and dermal cosmetic products.

    2. SCCS is requested to address any further scientific concerns with regard to the use of Colloidal Silver in nano form in cosmetic products.

    In addition to the safety assessment of colloidal silver in nano form, consideration should also be given to the likely presence of ionic silver in different types of final products.


    Keywords:

    SCCS, scientific opinion, colloidal silver (nano), CAS 7440-22-4, EC 231-131-3, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Colloidal Silver, 24-25 October 2018, SCCS/1596/2018.


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  • Styrene/Acrylates copolymer (nano) and Sodium styrene/Acrylates copolymer (nano) Abstract

    SCCS/1595/18 - 21-22 June 2018

    Styrene/Acrylates copolymer (nano) and Sodium styrene/Acrylates copolymer (nano)

    Link to opinion

    WG on Nanomaterials in Cosmetics
    SCCS members: U. Bernauer (Chair of the WG), L. Bodin, Q. Chaudhry (SCCS Chair), P.J. Coenraads (SCCS Vice-Chair), M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven
    SCHEER members: P.H.M. Hoet, W.H. de Jong (Rapporteur)
    SCCS external experts: N. von Götz, A. Simonnard
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1595/18
    Adopted on: 21-22 June 2018


    Conclusion of the opinion:

    1. In view of above, and taking into account the scientific data provided, the SCCS is requested to give its opinion on the safety of the nanomaterial Styrene/acrylates copolymer and Sodium styrene/Acrylates copolymer when used in leave-on cosmetics products with a maximum concentration limit of 0.06%, taking into account the reasonably foreseeable exposure conditions.

    The SCCS cannot conclude on the safety of any of the three styrene/acrylate copolymer nano-entities submitted by the Applicants. The data submitted are insufficient to evaluate possible toxicity. Regarding use it was reported that the nano-entities as present in Nanospheres 100 Theophyllisilane C (SA), were used for encapsulation of a slimming agent Theophyllisilane C. According to the information provided by the Applicants, the formulation might be used in health products like milks, emulsions, creams, lotions and solutions. However, no data on the use frequency was provided, so, the potential exposure could not be estimated based on a use scenario. In addition, the submitted information was based on a (nearly) finished product consisting of a nanomaterial shell (Nanosphere 100) and encapsulated active ingredients (Theophyllisilane C and Algisium C2 (SA) methylsilanol mannuronate). For the formulation Nanospheres 100 D.S.H. C.N (SA), no information on composition was submitted.

    Data should be provided separately for all of the three styrene/acrylate nanospheres, including any encapsulated substances.

    2. SCCS is requested to address any further scientific concerns with regard to the use of Styrene/ acrylates copolymer and Sodium styrene/Acrylates copolymer in nano form in cosmetic products.

    For applications as evaluated in this Opinion, it is imperative that the safety assessment not only considers safety of the individual components (e.g. the encapsulating material and the encapsulated contents), but also the safety of all the components when put together in the form of a nano-sized entity.


    Keywords:

    SCCS, scientific opinion, Styrene/Acrylates copolymer (nano) CAS No 9010-92-8, EC No 927-710-1, Sodium styrene/Acrylates copolymer (nano) CAS No 9010-92-8, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Styrene/Acrylates copolymer (nano) and Sodium styrene/Acrylates copolymer (nano), 21 February 2018, SCCS/1595/2018.


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  • Titanium Dioxide (nano form) as UV-Filter in sprays Abstract

    SCCS/1583/17 - 7 March 2017 - Final version of 19 January 2018

    Titanium Dioxide (nano form) as UV-Filter in sprays

    Link to opinion

    WG on Nanomaterials in cosmetic products
    SCCS members: U. Bernauer (Chairperson), L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads, M. Dusinska, E. Gaffet, C.L. Galli, E. Panteri, C. Rousselle, M. Stępnik, S. Wijnhoven
    SCHEER members: P.H.M. Hoet, W.H. de Jong
    External expert:N. von Götz (Rapporteur)
    Former SCCS members:J. Duus-Johansen, W. Lilienblum, T. Platzek, J. van Benthem
    Former SCENIHR members:A. Bernard, O. Bussolati, S. H. Doak, T. Jung
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1583/17
    Adopted on: 19 January 2018


    Conclusion of the opinion:

    1. In light of the data provided, does the SCCS consider Titanium Dioxide (nano) safe when used as UV-Filter in sunscreens and personal care spray products at a concentration up to 5.5%?

    From analysis of the submitted dossier, the SCCS has concluded that the information provided is insufficient to allow assessment of the safety of the use of nano-TiO2 in spray applications that could lead to exposure of the consumer’s lungs.

    The dossier provides exposure studies that have been conducted with water-based sprayable products with low alcohol content, which according to the market overview currently represent around 80% of the sprayable sunscreen products on the EU market. For the non-water-based formulations or formulations that contain alcohol >10% per weight, which currently may represent around 20% of the sprayable sunscreen products on the EU market, no exposure data were submitted, so that these could not be evaluated at all. The submission also does not provide adequate toxicological evaluation of nano-TiO2 relevant to the inhalation route, which would allow deriving a point of departure for the safety evaluation using worst-case assumptions. During the commenting period on the preliminary Opinion, the Applicant provided a new submission, the analysis of which (Section 3.3.13) showed that it has also not addressed the SCCS concerns over the safety of titanium dioxide (nano) when used as UV-filter in sunscreen and personal care sprayable products.

    2. Does the SCCS have any further scientific concerns regarding the use of Titanium Dioxide (nano) when used as UV-Filter in sunscreens and personal care spray products?

    The SCCS has been made aware by the new submission of the Applicant that there are already sprayable products on the market containing nano forms of TiO2. Such uses need to be carefully evaluated so that the chance of harmful effects through consumer's lung exposure by inhalation is avoided.


    Keywords:

    SCCS, scientific opinion, nano-TiO2, UV-filter, sprays, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Titanium Dioxide (nano form) as UV-filter in sprays, preliminary version of 7 March 2017, final version of 19 January 2018, SCCS/1583/17.


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  • Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetic Abstract

    SCCS/1580/16 - 7 November 2016 - Final version of 7 March 2017
    Corrigendum of 22 June 2018: the respective percentages of the coating materials were added in Chapter 4.

    Opinion on Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetic

    Link to opinion

    WG on Nanomaterials in Cosmetic products
    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Duus-Johansen, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, C. Rousselle, M. Stępnik, S. Wijnhoven
    SCHEER members: P. Hoet, W. de Jong
    External members: N. von Götz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1580/16
    Adopted on: 7 November 2016


    Conclusion of the opinion:

    (1) In light of the data provided, does the SCCS consider safe the use of Cetyl Phosphate, Manganese Dioxide and Triethoxycaprylylsilane as coatings for Titanium Dioxide (nano) used as UV-filter in dermally-applied cosmetic products?

    In view of the above discussion, which indicates a general lack of dermal absorption and low general toxicity of nano-forms of titanium dioxide, the SCCS considers that the use of the three TiO2 nanomaterials (A, B, C), coated with either cetyl phosphate, manganese dioxide or triethoxycaprylylsilane, can be considered safe for use in cosmetic products intended for application on healthy, intact or sunburnt skin. This, however, does not apply to applications that might lead to exposure of the consumer's lungs to the TiO2 nanoparticles through the inhalation route (such as powders or sprayable products).

    (2) Does the SCCS have any further scientific concerns regarding the use of the above-mentioned additional coatings for Titanium Dioxide (nano) used as UV-filter in dermally-applied cosmetic products?

    The ingredients used in some type of products (e.g. in lipsticks) may be incidentally ingested. The potential harmful effects of manganese dioxide should therefore be taken into account if the MnO2-coated nanomaterials are to be used for applications that could lead to oral ingestion.

    This Opinion is based on the currently available scientific evidence which shows an overall lack of dermal absorption of TiO2 nanoparticles. If any new evidence emerges in the future to show that the TiO2 nanoparticles used in a sunscreen formulation can penetrate skin (healthy, compromised, or damaged skin) to reach viable cells, then the SCCS may consider revising this assessment.

    As highlighted in the previous SCCS Opinion (SCCS/1516/13, 22 July 2013, Revision of 22 April 2014), there are certain knowledge gaps in regard to potential penetration of nanoparticles through cuts and bruises, or over repeated or long-term applications of a sunscreen formulation.

    It should also be noted that the risk assessment of nanomaterials is currently evolving. In particular, the toxicokinetics aspects have not yet been fully explored in the context of nanoparticles (e.g. the size dependency). Also, long-term stability of the coatings remains unclear. At the moment, both the testing of nanomaterials and the present assessment are based on the methodologies developed for substances in non-nano form and the currently available knowledge on properties, behaviour and effects of nanomaterials. This assessment is, therefore, not intended to provide a blue-print for future assessments of other nanomaterials, where depending on the developments in methodological risk assessment approaches and nano-specific testing requirements, additional/different data may be required and/or requested on a case-by-case basis.

    It is also important to note that the potential ecotoxicological impacts of nano TiO2 when released into the environment have not been considered in this Opinion.


    Keywords:

    SCCS, scientific opinion, Titanium Dioxide, coatings, nano form, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on additional coatings for Titanium Dioxide (nano form) as UV-filter in dermally applied cosmetic products, 7 November 2016, SCCS/1580/16.


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Fragrances

  • Methyl salicylate (methyl 2-hydroxybenzoate) Abstract

    SCCS/1633/21 - 26-27 October 2021

    Methyl salicylate (methyl 2-hydroxybenzoate)

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur), M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1633/21
    Adopted on: 26-27 October 2021


    Conclusion of the opinion:

    (1) In light of the data provided and taking under consideration the RAC Opinion on Methyl salicylate and the expected new classification as Toxic for Reproduction Category 2 of Methyl salicylate (to be introduced by an update of Annex VI Reg. 1272/2008), does the SCCS consider Methyl salicylate safe when used up to the maximum concentrations provided in the dossier submitted by the applicant?

    The SCCS considers Methyl salicylate safe when used in cosmetic products up to the maximum concentrations provided in the dossier submitted by the applicant as detailed in Table 1.

    (2) Does the SCCS have any further scientific concerns with regard to the use of Methyl salicylate in cosmetic products, also in relation to the RAC recommended classification of Methyl salicylate as ‘Skin sensitizer Category 1B’?

    Methyl salicylate should be considered as a weak skin sensitiser in humans and eye irritant.

    Moreover the SCCS would like also to express other concerns related to the use of methyl salicylate:

    - Methyl salicylate can be used in consumer products other than cosmetic products, such as household cleaning products, air care products, biocides (e.g. disinfectants, pest control products), polishes and waxes which may increase the systemic exposure dose with a possibility to exceed the safe level.

    - Methyl salicylate will be metabolised in the body to salicylic acid which is also classified as a reprotoxicant and used in cosmetic products (see opinion SCCS/1601/18). Therefore the combined exposure to cosmetic products containing various salicylates may increase the systemic exposure dose with a possibility to exceed the safe level.

    The SCCS also notices that wintergreen oil that is used in cosmetic products may contain up to 99% methyl salicylate. Therefore when calculating the content of methyl salicylate in a cosmetic product, any fraction coming from wintergreen oil should also be considered.


    Keywords:

    SCCS, scientific opinion, methyl salicylate, methyl 2-hydroxybenzoate, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on methyl salicylate (methyl 2-hydroxybenzoate), preliminary version of 24-25 June, final version of 26-27 October 2021, SCCS/1633/21.


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  • Scientific Advice on the SCCS Opinion on methyl-N-methylanthranilate (MNM)(SCCS/1455/11) Abstract

    SCCS/1616/20 - 16 October 2020
    Corrigendum of 1 June 2021 to align the abstract sentence with the conclusion of the SCCS

    Scientific Advice on the SCCS Opinion on methyl-N-methylanthranilate (MNM)(SCCS/1455/11)

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson and Rapporteur), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1616/20
    Adopted on: 16 October 2020


    Conclusion of the opinion:

    We would like to request scientific advice on whether the sentence from the SCCS Opinion (SCCS/1455/11) "…the SCCS considers that for the use in sunscreen/sun care products or products (including fragrances) intended for use on areas exposed to light (especially face and neck), a risk cannot be excluded" means that methyl-Nmethylanthranilate should not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light, but is considered safe to be used up to 0.1% for leave-on and 0.2% for rinse-off products".

    In the SCCS’s opinion, Methyl-N-methylanthranilate should not be used in sunscreen products and other products marketed specifically for exposure to natural/artificial UV light.

    It is considered safe to be used up to 0.1% for leave-on and 0.2% for rinse-off products.


    Keywords:

    : SCCS, scientific advice, fragrance ingredient, methyl-N-methylanthranilate (SCCS/1455/11), Regulation 1223/2009, CAS No. 85-91-6, EC No. 201-642-6, SCCS/1616/20


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Scientific advice on the SCCS Opinion on methyl-N-methylanthranilate – MNM (SCCS/1455/11), final version of 16 October 2020, SCCS/1616/20.


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  • The safety of Butylphenyl methylpropional (p- BMHCA) in cosmetic products - Submission II Abstract

    SCCS/1591/17 - 10 May 2019

    The safety of Butylphenyl methylpropional (p- BMHCA) in cosmetic products - Submission II

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stepnik (Rapporteur), T. Vanhaecke, S. Wijnhoven
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1591/17
    Adopted on: 10 May 2019


    Conclusion of the opinion:

    1. Does the SCCS consider Butylphenyl methylpropional (p-BMHCA) safe for use as a fragrance ingredient in cosmetic leave-on and rinse-off type products in a concentration limit(s) according the ones set up by IFRA as reported above?

    On individual product basis, Butylphenyl methylpropional (p-BMHCA) (CAS 80-54-6) with alpha-tocopherol at 200 ppm, can be considered safe when used as fragrance ingredient in different cosmetic leave-on and rinse-off type products. However, considering the first-tier deterministic aggregate exposure, arising from the use of different product types together, Butylphenyl methylpropional at the proposed concentrations cannot be considered as safe.

    This Opinion is not applicable to the use of p-BMHCA in any sprayable products that could lead to exposure of the consumer’s lung by inhalation.

    2. Does the SCCS have any further scientific concerns with regard to the use of Butylphenyl methylpropional (p-BMHCA) as a fragrance ingredient in cosmetic leave-on and/or rinse-off type products?

    Evaluation of this substance by other scientific bodies (e.g. under REACH) should also be taken into consideration by the Applicant for potential future assessment of the substance. Butylphenyl methylpropional is also used as a fragrance ingredient in some non-cosmetic products such as household cleaners and detergents. As no specific exposure data were made available to SCCS to assess exposure following these non-cosmetic uses, it was not possible to include them in the aggregated exposure scenarios. Therefore, the actual total exposure of the consumer may be higher than exposure from cosmetic products alone.


    Keywords:

    SCCS, scientific opinion, Butylphenyl methylpropional (p-BMHCA) in cosmetic products Submission II, Regulation 1223/2009, CAS 80-54-6, EC 201-289-8


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products - Submission II, preliminary version of 14 December 2017, final version of 10 May 2019, SCCS/1591/2017.


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  • Fragrance ingredient Acetylated Vetiver Oil (AVO) - submission III Abstract

    SCCS/1599/18 - 26 February 2019
    Corrigendum of 20-21 June 2019

    Fragrance ingredient Acetylated Vetiver Oil (AVO) - submission III

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli (Rapporteur), B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Simonnard, A. Koutsodimou
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1599/18
    Adopted on: 26 February 2019


    Conclusion of the opinion:

    1. On the basis of currently available information, does the SCCS consider Acetylated Vetiver Oil (AVO) safe for use as fragrance ingredient in cosmetic leave-on and rinse-off type products in a concentration limit(s) according to the once set up by IFRA as reported above?

    On the basis of the safety assessment carried out using a conservative approach, the SCCS considers the use of Acetylated Vetiver Oil (AVO) with 1% alpha-tocopherol as a fragrance ingredient in cosmetic leave-on and rinse-off type products safe at the concentrations proposed by IFRA.

    2. Does the SCCS have any further scientific concerns with regard to the use of Acetylated Vetiver Oil (AVO) as fragrance ingredient in cosmetic leave-on and rinse-off type products?

    Acetylated Vetiver Oil (AVO) contains some constituents that belong to the chemical group of aldehydes and ketones that are known to be reactive towards biological entities, such as DNA and proteins. However, the overall health risk of such components is likely to be negligible at the concentrations intended to be used in cosmetics products.

    The SCCS has noted that Acetylated Vetiver Oil (AVO) is a moderate skin sensitiser in test animals. Considering the results of the HRIPT study and the fact that AVO has been used for years in cosmetics without evidence of sensitising potential, it is unlikely that AVO would be causing contact allergy in humans.

    Inhalation toxicity of Acetylated Vetiver Oil (AVO) was not assessed in this Opinion because no data were provided. Assessment of the inhalation risk would be needed if AVO was intended to be used in sprayable products.


    Keywords:

    SCCS, scientific opinion, Acetylated Vetiver Oil (AVO), Regulation 1223/2009, Vetiverol acetate CAS 62563-80-8; Vetiveria zizanioides ext. acetylated, CAS 84082-84-8, EC 282-031-1, SCCS/1599/18


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on fragrance ingredient Acetylated Vetiver Oil (AVO) - Submission III, SCCS/1599/18, preliminary version of 21-22 June 2018, final version of 26 February 2019, CORRIGENDUM on 20-21 June 2019.


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Hair dyes

  • Opinion on Lawsonia inermis (Henna) (C169)Abstract

    SCCS/1511/13 - 19 September 2013
    Corrigendum of 12 November 2021 – Revision of the calculation of the Margin of Safety – no change in safe conclusion.

    Opinion on Lawsonia inermis (Henna) (C169)

    Link to opinion

    WG on Hair Dyes
    SCCS members:M. Dusinska, D. Gawkrodger, W. Lilienblum, M. Metzler, E. Nielsen, T. Platzek (chairman and rapporteur), S.C. Rastogi, C. Rousselle, J. van Benthem
    External experts:M. Pilar Vinardell, I. White, T. Sanner
    Contact:SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1511/13
    Doi: 10.2772/71314
    Adopted on: 19 September 2013


    Conclusion of the opinion:

    The SCCS is of the opinion that the information provided is sufficient to assess the safe use of Henna as a hair dye. The assessment is based on the Henna batches 1271 and 830.72 under functions and uses, e.g. 100 g Henna powder mixed with 300 ml boiling water Henna is considered safe for the consumer. Other kinds of extracts of Henna that may have different compositions are not covered by this assessment. The traditional and current expanding use of Henna Rot (Lawsonia inermis) as a body-paint has not been assessed. Additionally, a reassessment of the genotoxicity of Lawsone by the SCCS is desirable.


    Keywords:

    SCCS, scientific opinion, hair dye, C169, lawsonia inermis, henna, directive 76/768/ECC, CAS 84988-66-9, EC 284-854-1


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Lawsonia inermis (henna), 19 September 2013.


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  • Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5) - Submission II Abstract

    SCCS/1631/21 - 23 July 2021

    Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5) - Submission II

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli (Rapporteur), B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1631/21
    Adopted on: 23 July 2021


    Conclusion of the opinion:

    (1) In light of the data provided, does the SCCS consider Acid Yellow 3, safe when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5 %?

    Based on the data provided in the dossier, the SCCS considers that Acid Yellow 3 is safe when used in non-oxidative hair colouring products at on-head concentrations of up to 0.5%.

    (2) Does the SCCS have any further scientific concerns with regard to the use of Acid Yellow 3 in cosmetic products?

    A detailed analytical report on the test substance in representative batches and results of the stability tests should be provided to exclude the possibility of the presence of any impurities that may be of concern.


    Keywords:

    SCCS, scientific opinion, Acid Yellow 3, hair dye, Regulation 1223/2009, CAS Number 8004-92-0, EC No 305-897-5


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Acid Yellow 3 – C054 (CAS Number 8004-92-0, EC No 305-897-5), submission II, preliminary version of 7 May 2021, final version of 23 July 2021, SCCS/1631/21.


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  • Resorcinol Abstract

    SCCS/1619/20 - 30-31 March 2021

    Resorcinol

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson and Rapporteur), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik (Rapporteur), T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1619/20
    Adopted on: 30-31 March 2021


    Conclusion of the opinion:

    In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Resorcinol, does the SCCS consider Resorcinol safe when used as an oxidative hair dye in products intended for hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos?

    Keeping in view the evidence on endocrine disrupting properties of resorcinol, the SCCS assessment shows that resorcinol is safe when used as an oxidative hair dye in products intended for hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos.

    Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of Resorcinol as an oxidative hair dye in products intended for hair and eyelashes and for hair lotions and shampoos?

    /

    Does the SCCS have any further scientific concerns with regard to the use of Resorcinol in cosmetic products?

    Resorcinol is a moderate skin sensitiser based on data from animal studies. Clinical studies show that the frequency of contact sensitisation in humans is low.

    The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of resorcinol for the environment.


    Keywords:

    SCCS, scientific opinion, Resorcinol, hair dye, Regulation 1223/2009, CAS Number 108-46-3, EC No 203-585-2


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Resorcinol (CAS No 108-46-3, EC No 203-585-2), preliminary version of 16 October 2020, final version of 30-31 March 2021, SCCS/1619/20


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  • Hair dye Indigofera tinctoria (C170) CAS 84775-63-3 - Submission III Abstract

    SCCS/1615/20 - 3 April 2020

    Hair dye Indigofera tinctoria (C170) CAS 84775-63-3 - Submission III

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1615/20
    Adopted on: 3 April 2020


    Conclusion of the opinion:

    1. In light of the data provided, does the SCCS consider Indigofera tinctoria (C170) safe when used in non-oxidative conditions hair colouring products at on-head concentrations of up to 25%?

    In light of the data provided, the SCCS considers that Indigofera tinctoria is safe when used in non-oxidative condition hair colouring products at on-head concentrations of up to 25%.

    2. Does the SCCS have any further scientific concerns with regard to the use of Indigofera tinctoria (C170) in cosmetic products?

    A weak skin sensitisation potential cannot be excluded for Indigofera tinctoria.


    Keywords:

    SCCS, scientific opinion, Indigofera tinctoria, C170, hair dye, Regulation 1223/2009, CAS 84775-63-3, EC 283-892-6


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on hair dye Indigofera tinctoria (C170), Submission III, preliminary version of 10 January 2020, final version of 3 April 2020, SCCS/1615/20.


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  • Dihydroxyacetone - DHA (1,3-Dihydroxy-2-propanone) CAS No. 96-26-4 Abstract

    SCCS/1612/19 - 03-04 March 2020

    Dihydroxyacetone - DHA (1,3-Dihydroxy-2-propanone) CAS No. 96-26-4

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1612/19
    Adopted on: 03-04 March 2020


    Conclusion of the opinion:

    In light of the data provided, does the SCCS consider Dihydroxyacetone safe when used as hair colouring ingredient in leave-on applications up to a maximum concentration of 6.25 %?

    On the basis of data provided, the SCCS considers Dihydroxyacetone safe when used as hair colouring ingredient in leave-on applications (non-oxidative) up to a maximum concentration of 6.25%.

    Does the SCCS have any further scientific concerns with regard to the use of Dihydroxyacetone in cosmetic products?

    The use of Dihydroxyacetone as hair colouring ingredient in leave-on applications (nonoxidative) up to a maximum concentration of 6.25% together with the use of self-tanning lotion and face cream containing up to a maximum concentration of 10% Dihydroxyacetone is considered safe


    Keywords:

    SCCS, scientific opinion, preservative, Dihydroxyacetone (DHA), 1,3-Dihydroxy-2-propanone, CAS 96-26-4, EC 202-494-5, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Dihydroxyacetone (DHA) CAS N° 96-26-4, preliminary version of 30-31 October 2019, final version of 03-04 March 2020, SCCS/1612/19.


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  • Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183) - Submission IV Abstract

    SCCS/1610/19 - 13 December 2019

    Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183) - Submission IV

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli (Rapporteur), B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1610/19
    Adopted on: 13 December 2019


    Conclusion of the opinion:

    In light of the new data provided, does the SCCS consider Tetrabromophenol Blue (C183) safe when used as a hair dye in oxidative and non-oxidative hair colouring products with a final onhead concentration of up to 0.2%?

    Based on the overall weight of evidence derived from the data provided, and the large margin of safety, the SCCS considers Tetrabromophenol Blue (C183) safe when used as a hair dye in oxidative and non-oxidative hair colouring products at a final on-head concentration of up to 0.2%.


    Keywords:

    SCCS, scientific opinion, Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1- dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183), Regulation 1223/2009, CAS 4430-25-5


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183), preliminary version of 10 September 2019, final version of 13 December 2019, SCCS/1610/19.


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  • Hair dye Methylimidazoliumpropyl p-phenylenediamine HCl (A166)(CAS 220158-86-1) - Submission I Abstract

    SCCS/1609/19 - 30-31 October 2019

    Hair dye Methylimidazoliumpropyl p-phenylenediamine HCl (A166)(CAS 220158-86-1) - Submission I

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet (Rapporteur), C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1609/19
    Adopted on: 30-31 October 2019


    Conclusion of the opinion:

    In light of the data provided, does the SCCS consider Methylimidazoliumpropyl p-phenylenediamine HCl (A166), safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2 %?

    Based on the full set of information provided by Applicant (including additional information provided during the commenting period), the SCCS considers Methylimidazoliumpropyl p-phenylenediamine HCl (A166) safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2%.

    2. Does the SCCS have any further scientific concerns with regard to the use of Methylimidazoliumpropyl p-phenylenediamine HCl (A166) in cosmetic products?

    The SCCS has noted that Methylimidazoliumpropyl p-phenylenediamine HCl (A166) is a strong skin sensitiser.


    Keywords:

    SCCS, scientific opinion, hair dye, Methylimidazoliumpropyl p-phenylenediamine HCl (A166), Regulation 1223/2009, CAS 220158-86-1


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on hair dye Methylimidazoliumpropyl p-phenylenediamine HCl (A166), preliminary version adopted on 29 July 2019, final version adopted on 30-31 October 2019, SCCS/1609/19.


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  • Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165) Abstract

    SCCS/1608/19 - 30-31 October 2019

    Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165)

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1608/19
    Adopted on: 30-11 October 2019


    Conclusion of the opinion:

    In light of the data provided, does the SCCS consider Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165), safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2 %?

    In light of the data provided, the SCCS considers that hydroxypropyl p-phenylenediamine and its dihydrochloride salt are not safe when used in oxidative hair colouring products due to potential genotoxicity.

    2. Does the SCCS have any further scientific concerns with regard to the use of Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165) in cosmetic products?

    A mild to moderate eye irritation potential of the test item cannot be excluded. Hydroxypropyl p-phenylenediamine 2HCl is a moderate skin sensitiser based on animal data.


    Keywords:

    SCCS, scientific opinion, Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165), Regulation 1223/2009, CAS base 73793-79-0 and salt 1928659-47-5, SCCS/1608/19


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165), preliminary version of 20-21 June 2019, final version of 30-31 October 2019, SCCS/1608/19.


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  • Hair dye 1,2,4-trihydroxybenzene (1,2,4-THB) - A33 (CAS 533-73-3) - Submission VI Abstract

    SCCS/1598/18 - 21-22 June 2018 - Final version of 20-21 June 2019

    Hair dye 1,2,4-trihydroxybenzene (1,2,4-THB) - A33 (CAS 533-73-3) - Submission VI

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik (Rapporteur), T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1598/18
    Adopted on: 20-21 June 2019


    Conclusion of the opinion:

    1. In light of the data provided, does the SCCS consider 1,2,4-trihydroxybenzene (1,2,4-THB) (A33) safe for use as an auto-oxidative hair dye in permanent hair dye formulations, not requiring the action of peroxide, with a maximum on-head concentration of 2.5%?

    On the basis of all the data submitted by the Applicant, and the data available in open literature, the SCCS does not consider 1,2,4-trihydroxybenzene safe due to potential genotoxicity when used as an auto-oxidative hair dye component in permanent hair dye formulations.

    The data provided by the Applicant indicate that consumers would be exposed to unreacted 1,2,4-THB and (semi)quinones during the use of a 1,2,4-THB containing hair dye formulation. The systemic availability of 1,2,4-THB raises the risk of intracellular generation of hydrogen peroxide, as well as potential genotoxicity via DNA adduct formation by 1,2,4-THB and/or (semi)quinones. These aspects have not been addressed in the studies provided in the submission.

    2. In light of the data provided, does the SCCS consider 1,2,4-trihydroxybenzene (1,2,4-THB) (A33) safe for use as an auto-oxidative hair dye in hair colour shampoo formulations, not requiring the action of peroxide, with a maximum on-head concentration of 0.7%?

    See above.

    3. Does the SCCS have any further scientific concerns with regard to the use of 1,2,4-trihydroxybenzene (1,2,4-THB) (A33) in cosmetic products?

    /


    Keywords:

    SCCS, scientific opinion, 1,2,4-trihydroxybenzene (1,2,4-THB), A33, hair dye, CAS: 533-73-3, EC 208-575-1, SCCS/1598/18, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion 1,2,4-trihydroxybenzene (1,2,4-THB) - A33 – Submission VI, preliminary version of 21-22 June 2018, final version of 20-21 June 2019, SCCS/1598/18.


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  • Addendum to the scientific Opinion SCCS/1491/12 on the hair dye substance 2-Methoxy-methyl-p-phenylenediamine and its sulfate salt - COLIPA n° A160 - Submission II – use on eyelashes Abstract

    SCCS/1603/18 - 21 December 2018 - Final version of 12 March 2019

    Addendum to the scientific Opinion SCCS/1491/12 on the hair dye substance 2-Methoxy-methyl-p-phenylenediamine and its sulfate salt - COLIPA n° A160 - Submission II – use on eyelashes

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1603/18
    Adopted on: 12 March 2019


    Conclusion of the opinion:

    1. In light of the data provided, does the SCCS consider 2-methoxy-methyl-p-phenylenediamine and its sulfate salt (A160) safe when used in oxidative eyelash colour products at maximum in-use concentration of 1.8 %?

    Based on all data provided, the SCCS considers that 2-methoxy-methyl-p-phenylenediamine and its sulfate salt (A160) are safe to be used in oxidative eyelash colour products at the proposed maximum in-use concentration of 1.8%.


    Keywords:

    SCCS, addendum, scientific opinion, hair dye, 2-methoxy-methyl-p-phenylenediamine, A160, CAS 337906-36-2, Regulation 1223/2009, SCCS/1603/18


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Addendum to the Opinion SCCS/1491/12 on 2-methoxy-methyl-p-phenylenediamine) – A160 – Submission II, preliminary version of 21 December 2018, final version of 12 March 2019, SCCS/1603/18.


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  • Dimethylpiperazinium Aminopyrazolopyridine HCl (A164) Abstract

    SCCS/1584/17 - 7 March 2017 - Final version of 6 June 2017

    Dimethylpiperazinium Aminopyrazolopyridine HCl (A164)

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stępnik (Rapporteur), T. Vanhaecke, S. Wijnhoven
    Former SCCS member: J. Duus-Johansen
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1584/17
    Adopted on: 7 March 2017


    Conclusion of the opinion:

    1. In light of the data provided, does the SCCS consider Dimethylpiperazinium Aminopyrazolopyridine HCl (A164), safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2%?

    On the basis of data provided, the SCCS considers Dimethylpiperazinium Aminopyrazolopyridine HCl (A164) safe when used in oxidative hair colouring products up to a maximum on-head concentration of 2%.

    2. Does the SCCS have any further scientific concerns with regard to the use of Dimethylpiperazinium Aminopyrazolopyridine HCl (A164) in cosmetic products?

    Chemical characterisation and quantification of the oxidation product(s) detected in some batches have not been provided.


    Keywords:

    SCCS, scientific opinion, Dimethylpiperazinium Aminopyrazolopyridine HCl (A164), Regulation 1223/2009, CAS 1256553-33-9


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Dimethylpiperazinium Aminopyrazolopyridine HCl (A164), preliminary version of 7 March 2017, SCCS/1584/17.


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  • Basic Blue 99 (C059) Abstract

    SCCS/1585/17 - 7 March 2017 - Final version of 6 June 2017

    Basic Blue 99 (C059)

    Link to opinion

    WG on Cosmetic ingredients
    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, C.L. Galli, B. Granum, E. Panteri (Rapporteur), V. Rogiers, C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
    Former SCCS member: J. Duus-Johansen
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1585/17
    Adopted on: 7 March 2017


    Conclusion of the opinion:

    1. In light of the new data provided, does the SCCS consider Basic Blue 99 (C059) safe as direct hair dye substance in hair dye formulations with a concentration on-head up to a maximum of 1.0%?

    The SCCS cannot conclude on the safety of Basic Blue 99 (C059) because it is composed of several substances and isomeric forms, with a large variability between the composition of different batches. Also, the toxicological data provided in the previous submission do not relate to the material specifications provided for the current assessment. The safety assessment of Basic Blue 99 will require a clear well-defined set of specifications for the composition of the material intended to be used in cosmetic products as well as supporting toxicological data relating to a representative composition.

    2. Does the SCCS have any further scientific concerns with regard to the use of Basic Blue 99 (C059) in cosmetic products?

    /


    Keywords:

    SCCS, scientific opinion, hair dye, Basic Blue 99 (C059), Regulation 1223/2009, 30 CAS: 68123-13-7, EC: 268-544-3


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Basic 34 Blue 99 (C059), 7 March 2017, SCCS/1585/17.


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  • Tetrabromophenol Blue (C183)Abstract

    SCCS/1573/16 - 16 March 2016 - Final version of 7 March 2017

    Opinion on Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183)

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: Q. Chaudhry, P. Coenraads, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, C. Rousselle, J. van Benthem
    External experts: A. Bernard, L. Bodin, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova, E. Panteri, T. Vanhaecke, A. Varvaresou
    Contact: SANCO-C2-SCCSatec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1573/16
    Adopted on: 16 March 2016


    Conclusion of the opinion:

    1. In light of the new data provided, does the SCCS consider Tetrabromophenol Blue (C183) safe when used as a direct dye in oxidative and non-oxidative hair colouring products with a final on-head concentration up to 0.2%?

    The margin of safety calculated in this Opinion relates to the previously supplied batch quality of the material. However, because of the large discrepancies noted between the specifications provided for the representative market quality batch intended for commercial use and that used in toxicological testing, SCCS cannot conclude on the safety of Tetrabromophenol Blue (C183).

    The test material is not composed of a single substance, but of different homologues. Analysis of different batches has shown a large variation in the homologue mixture composition of the test material intended for commercial use. The safety assessment of Tetrabromophenol Blue (C183) will require a clear well-defined set of specifications for the composition of the substance intended for use in cosmetic products. This will also require toxicological data on a representative batch, and/or a scientifically valid justification for showing toxicological similarities amongst the homologues.

    2. Does the SCCS have any further scientific concerns with regard to the use of Tetrabromophenol Blue (C183) in other cosmetic products?

    /


    Keywords:

    SCCS, scientific opinion, Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183), Regulation 1223/2009, CAS 4430-25-5


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183), 16 March 2016, SCCS/1573/16.


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  • HC Orange No. 6 (B125)Abstract

    SCCS/1579/16 - 7 November 2016

    Opinion on HC Orange No. 6 (B125)

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Duus-Johansen, J. Ezendam, E. Gaffet, C.L. Galli, B. Brunstad Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
    Contact: SANCO-C2-SCCSatec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1579/16
    Adopted on: 7 November 2016


    Conclusion of the opinion:

    (1) In light of the data provided, does the SCCS consider HC Orange No. 6 (B125) safe when used in non-oxidative hair colouring products at a maximum concentration of 0.5%?

    The SCCS considers HC Orange No. 6 (B125) safe when used in non-oxidative hair colouring products at a maximum concentration of 0.5%.

    (2). Does the SCCS have any further scientific concerns with regard to the use of HC Orange No. 6 (B125) in cosmetic products?

    The SCCS has concerns regarding a potential presence of methanesulfonates impurities, in particular ethyl methanesulfonate. Information on these impurities has not been provided.


    Keywords:

    SCCS, scientific Opinion, HC Orange No. 6 (B125), Regulation 1223/2009, CAS 1449653-83-1


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on HC Orange No. 6 (B125), 7 November 2016, SCCS/1579/16.


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  • N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine (B34)Abstract

    SCCS/1572/16 - 16 September 2016

    Opinion on N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine (B34) - Submission IV

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: Q. Chaudhry, P. Coenraads, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, C. Rousselle, J. van Benthem
    External experts: A. Bernard, L. Bodin, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova, E. Panteri, T. Vanhaecke, A. Varvaresou
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1572/16
    Adopted on: 16 September 2016


    Conclusion of the opinion:

    (1) In light of the new data provided, does the SCCS consider N,N'-Bis-(2-hydroxyethyl)-2- nitro-p-phenylamine (B34) safe when used as an oxidative hair dye with a concentration onhead of maximum 1.0 % and as a non-oxidative hair dye with a concentration up to 1.5 %?

    On the basis of new submitted data, the SCCS considers N,N’-bis(2-hydroxyethylamino)-2- nitro-pphenylenediamine safe for use as an oxidative hair dye with an on-head concentration of maximum 1.0% and as a non-oxidative hair dye with a concentration up to 1.5%.

    (2) Does the SCCS have any further scientific concerns with regard to the use of N,N’-Bis-(2- hydroxyethyl)-2-nitro-p-phenylamine (B34) in other cosmetic products?

    N,N’-bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine is a secondary amine and prone to nitrosation. The nitrosamine content in the dye should be < 50 ppb. It should not be used in the presence of nitrosating agents.

    A selective analytical method, such as HPLC with PDA detection, should be used to demonstrate stability for up to 60 min. under oxidative conditions.


    Keywords:

    SCCS, scientific opinion, N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine (B34), Regulation 1223/2009, CAS No. 84041-77-0, EC No. 281-856-4


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on N,N'- Bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine (B34), 16 March 2016, final version of 16 September 2016, SCCS/1572/16.


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Preservatives

  • Propylparaben Abstract
    SCCS/1623/20 - 30-31 March 2021

    Propylparaben

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard (Rapporteur until 27 July 2020), W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1623/20
    Adopted on: 30-31 March 2021


    Conclusion of the opinion:

    1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Propylparaben, does the SCCS consider Propylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %?

    On the basis of the safety assessment of Propylparaben, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %.

    2. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of Propylparaben as a preservative in cosmetic products?

    /

    3. Does the SCCS have any further scientific concerns with regard to the use of Propylparaben in cosmetic products?

    The available data on Propylparaben provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment.

    The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of propylparaben for the environment.


    Keywords:

    SCCS, scientific opinion, Propylparaben, preservative, Regulation 1223/2009, CAS No 94-13-3, EC No 202-307-7


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Propylparaben (CAS No 94-13-3, EC No 202-307-7), preliminary version of 27-28 October 2020, final version of 30-31 March 2021, SCCS/1623/20.


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  • Zinc Pyrithione (ZPT) - Submission III Abstract

    SCCS/1614/19 - 03-04 March 2020

    Zinc Pyrithione (ZPT) - Submission III

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1614/19
    Adopted on: 03-04 March 2020


    Conclusion of the opinion:

    1. In view of the conditions laid out in Article 15(d) of the Regulation (EC) No 1223/2009 and taking into account the scientific data provided, does the SCCS consider Zinc Pyrithione safe when used as an anti-dandruff in rinse-off hair products up to a maximum concentration of 1%?

    In line with the conditions laid out in Article 15(d) (i.e. ‘overall exposure from other sources’) of the Regulation (EC) No 1223/2009 and taking into account the scientific data provided, the SCCS considers Zinc Pyrithione (ZPT) as safe when used as an anti-dandruff in rinse-off hair products up to a maximum concentration of 1%.

    2. Does the SCCS have any further scientific concerns with regard to the use of Zinc Pyrithione in cosmetic products?

    /


    Keywords:

    SCCS, scientific opinion, preservative, Zinc Pyrithione, ZPT, P81, submission III, Regulation 1223/2009, CAS 13463-41-7, EC 236-671-3


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Zinc Pyrithione (ZPT) (P81) CAS N° 13463-41-7 submission III, Regulation 1223/2009, CAS 13463-41-7, preliminary version of 13 December 2019, final version of 03-04 March 2020, SCCS/1614/19.


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  • Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 – CAS No 569646-79-3 Submission II (eye irritation) Abstract

    SCCS/1604/18 - 5 March 2019

    Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 – CAS No 569646-79-3 Submission II (eye irritation)

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. Wijnhoven
    SCCS external experts: A. Simonnard, A. Koutsodimou, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1604/18
    Adopted on: 5 March 2019


    Conclusion of the opinion:

    1. In light of the new studies provided, does the SCCS consider the use of Hydroxyethoxyphenyl Butanone (HEPB) safe with regard to eye irritation, when used as preservative in rinse-off, oral care and leave-on cosmetic products with a maximum concentration of 0.7%?

    Based on the new information provided by the Applicant, the SCCS considers the use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products with a maximum concentration of 0.7 % safe with regard to eye irritation.


    Keywords:

    SCCS, scientific opinion, Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’(HEPB) - Cosmetics Europe No P98, CAS 569646-79-3, Regulation 1223/2009, SCCS/1604/18


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 – Submission II eye irritation, preliminary version of 21 December 2018, final version of 5 March 2019, SCCS/1604/18.


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  • Addendum to the scientific Opinions on Climbazole (P64) ref. SCCS/1506/13 and SCCS/1590/17 Abstract

    SCCS/1600/18 - 21-22 June 2018

    Addendum to the scientific Opinions on Climbazole (P64) ref. SCCS/1506/13 and SCCS/1590/17

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1600/18
    Adopted on: 21-22 June 2018


    Conclusion of the opinion:

    1. In light of the SCCS addendum (SCCS/1590/17), does the SCCS consider safe the use of Climbazole (CAS 38083-17-9) when used in cosmetic products in the following specified concentrations under an aggregate exposure scenario for cosmetics:

    - As a cosmetic preservative in face cream up to a concentration of 0.2%;
    - As a cosmetic preservative in hair lotion up to a concentration of 0.2%;
    - As a cosmetic preservative in foot care up to a concentration of 0.2%;
    - As a cosmetic preservative in rinse-off shampoo up to a concentration of 0.5%;
    - As an anti-dandruff agent in rinse-off shampoo up to a concentration of 2.0%.

    o The SCCS considers the specified concentrations when used as preservative, for the individual cosmetic products as well as for their combinations under aggregate exposure scenario as safe

    o When Climbazole is used as an anti-dandruff agent up to 2%, the 4-cosmetic products combination (with hair lotion, face cream and foot care) is also considered as safe

    o The SCCS therefore considers that the use of climbazole up to a concenration of 2% in shampoos is safe for the consumer, either as anti-dandruff agent or as a preservative agent in combination with other uses and at concentrations as listed above.

    2. If not, what is according to the SCCS, the maximum concentration considered safe for use of Climbazole (CAS 38083-17-9) as a cosmetic preservative respectively in face cream, hair lotion, foot care and rinse-off shampoo as well as anti-dandruff agent in rinse-off shampoo under an aggregate exposure scenario for cosmetics?

    /


    Keywords:

    SCCS, addendum, scientific opinion, Climbazole, preservative, P64, CAS 38083-17-9, EC 253-775-4, SCCS/1600/18, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Addendum to the scientific Opinions on climbazole (P64) ref. SCCS/1506/13 and SCCS/1590/17, final version adopted on 21-22 June 2018, SCCS/1600/18.


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  • Addendum to the scientific opinion on Zinc pyrithione (P81) ref. SCCS/1512/13 Abstract

    SCCS/1593/18 - 21-22 February 2018

    Addendum to the scientific opinion on Zinc pyrithione (P81) ref. SCCS/1512/13

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry (SCCS Chair), P. Coenraads (SCCS Vice-Chair and Chairperson of the WG), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (SCCS Vice-Chair), C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS members: A. Simonnard, A. Koutsodimou
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1593/18
    Adopted on: 21-22 February 2018


    Conclusion of the opinion:

    1. In light of the new evidence available, does the SCCS still consider that zinc pyrithione, when used in a concentration up to 2.0% as an anti-dandruff agent in rinse-off hair care products, is safe for the consumer as concluded in SCCS/1512/13?

    The newly provided studies on fertility and developmental toxicity did not lead to changes of point of departure for risk assessment compared to SCCS/1512/13. Further additional studies mentioned in the Swedish CLH proposal confirm neurotoxicity as a sensitive endpoint of ZPT toxicity. In view of the additional studies SCCS confirms the LOAEL of 0.5 mg/kg bw/d that was derived in SCCS/1512/13 as a conservative value for risk assessment of ZPT.

    Therefore ZPT is considered safe when used at a concentration up to 2.0% as an anti-dandruff agent in rinse-off hair care products.

    2. Does the SCCS have any further scientific concerns regarding the use of zinc pyrithione in cosmetic products?

    The conclusion from SCCS/1512/13 was specifically targeted to risk assessment for the particular use of ZPT in a concentration up to 2.0% as an anti-dandruff agent in rinse-off hair care products. Aggregate exposure from non-cosmetic sources has not been considered.

    In view of apparent further (non-cosmetic) uses and in view of the fact that classification as Repr 1B is currently proposed, the SCCS recommends risk assessment taking into consideration all possible sources of exposure in line with Art 15 of Cosmetics Regulation (EU 1223/2009).

    Not all relevant toxicological studies performed with ZPT have been made available to the SCCS (see section 3.1. Introduction of SCCS/1512/13).


    Keywords:

    SCCS, scientific opinion, addendum, preservative, P81, Zinc pyrithione, Regulation 1223/2009, CAS 13463-41-7


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), addendum to the Opinion on preservative Zinc pyrithione (P81) ref. SCCS/1512/13, 21-22 February 2018, SCCS/1593/18.


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  • Addendum to the Opinion on the use as preservative o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ref. SCCS/1555/15 Abstract

    SCCS/1597/18 - 21-22 February 2018

    Addendum to the Opinion on the use as preservative o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ref. SCCS/1555/15

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1597/18
    Adopted on: 21-22 February 2018


    Conclusion of the opinion:

    1. Does SCCS consider Sodium o-phenylphenate, Potassium o-phenylphenate and MEA o-Phenylphenate safe at the current use as preservatives with a maximum concentration of 0.2 % (as phenol)?

    Due to the lack of relevant information, the SCCS is unable to answer the question on the safe use level of sodium-OPP, potassium-OPP and MEA-OPP. In SCCS view, a direct comparison between the safety of o-phenylphenate (OPP) and its 3 compounds cannot be made due to the following concerns:

    • From the limited available information, it is clear that both sodium and potassium salts of OPP have much higher water solubility than OPP (no information available on MEAOPP). This can potentially alter their absorption and biokinetics, compared to OPP.

    • From the available information, the SCCS has noted that, compared to the strongly skin irritating nature of OPP, both sodium OPP and potassium-OPP are corrosive to the skin, and sodium OPP is also corrosive to the eye. This indicates that both sodium and potassium salts of OPP may have greater skin penetration and potentially more potent toxic effects than OPP due to higher systemic exposure. No relevant information on skin irritation is available for MEA-OPP but the presence of monoethyleneamine (MEA) moiety can also be expected to alter the skin absorption and biokinetics of MEA-OPP compared to OPP, and as a consequence also systemic exposure. For OPP, the SCCS has derived dermal absorption value of 45% from toxicokinetic information. However, such information is not available for sodium-OPP, potassium-OPP or MEA-OPP, and data would be needed to allow drawing any comparisons from the safe use levels of OPP.

    • The available in vivo studies in rat have also indicated that the adverse effects of OPP and its sodium salt are different. For the sodium salt, there is clear indication that the substance is more potent with respect to urinary bladder carcinoma and data point to mechanistic differences between OPP and SOPP. Amongst other factors, SOPP leads to higher sodium concentrations in urine and also to higher urinary pH. There is insufficient dose-response data available to draw a conclusion on the possibility of setting a threshold for sodium-OPP induced toxicity. The currently available data are also not sufficient to exclude such a possibility for the other two compounds (potassium-OPP and MEA-OPP). Long-term repeat dose studies have pointed out to a threshold between 35 and 40 mg/kg bw/d for OPP, but due to the lack of dose-response data, a threshold for sodium-OPP, potassium-OPP or MEA-OPP cannot be derived.

    2. Does the SCCS consider that the same conclusion for OPP, as reported in SCCS/1555/15, may also be applied to Sodium o-phenylphenate, Potassium ophenylphenate and MEA o-Phenylphenate concerning the proposed maximum use concentration (i.e. 0.15% in leave-on and 0.2% in rinse-off cosmetic products as preservatives)?

    For the reasons given above, the SCCS considers that the same conclusions on the safe use levels of OPP cannot be applied as such to sodium-OPP, potassium-OPP or MEA-OPP for use in rinse-off and leave-on cosmetic products.

    Based on the available information, the SCCS is of the opinion that a potential risk to human health from the use of sodium-OPP and potassium-OPP as preservatives in cosmetic products cannot be excluded.

    Although the safety of MEA-OPP was not evaluated in the Opinion SCCS/1555/15, the SCCS has a similar view that a potential risk from its use as preservative in cosmetic products cannot be excluded in the absence of relevant data.


    Keywords:

    SCCS, scientific opinion, preservative, Sodium o-phenylphenate, Potassium ophenylphenate, MEA o-Phenylphenate, Regulation 1223/2009, CAS n. 132-27-4, 13707-65- 8, 84145-04-0


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Addendum to the scientific opinion on the use as preservative of o-Phenylphenol, Sodium ophenylphenate and Potassium o-phenylphenate- Here: the use as preservative of Sodium o-phenylphenate, Potassium o-phenylphenate, MEA o-Phenylphenate 21- 22/02/2018, SCCS/1597/18.


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  • Addendum to the Opinion on Climbazole (P64) ref. SCCS/1506/13 Abstract

    SCCS/1590/17 - 24-25 October 2017

    Addendum to the Opinion on Climbazole (P64) ref. SCCS/1506/13

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1590/17
    Adopted on: 24-25 October 2017


    Conclusion of the opinion:

    1. In light of the new margin of safety data provided, does the SCCS consider safe the use of Climbazole (CAS 38083-17-9) as a cosmetic preservative in hair lotion and foot care with a maximum concentration of 0.31 % and in face cream with a maximum concentration of 0.5% and as anti-dandruff agent in shampoo with a maximum concentration of 2.0% under an aggregate exposure scenario for cosmetics?

    The use of Climbazole (CAS 38083-17-9) as a cosmetic preservative in hair lotion and foot care with a maximum concentration of 0.31 % and in face cream with a maximum concentration of 0.5% and as anti-dandruff agent in shampoo with a maximum concentration of 2.0% are, when individually used, safe for human health. Combinations of 3- or 4- products, however, cannot be considered as safe. Most combinations of 2 products can be considered as safe, the combinations of ‘hair lotion and face cream’ and ‘face cream and foot care’ give, using the conservative “adding on calculation”, a MoS below 100 (83 and 90, respectively).

    2. If not, what is, according to the SCCS, the maximum concentration considered safe for use of Climbazole (CAS 38083-17-9) as a cosmetic preservative in hair lotion, foot care and face cream as well as anti-dandruff agent in rinse-off shampoos under an aggregate exposure scenario for cosmetics?

    The maximum concentrations of Climbazole considered as safe for human health under an aggregate exposure scenario are as follows:
    2% as anti-dandruff agent in rinse-off shampoos and 0.2 % as cosmetic preservative in leave -on formulations (face cream, hair lotion, foot care) with the exception of cosmetics applied on a full body area (body lotion).

    Based on the considerations by ECHA, the SCCS will closely follow up the outcome of further studies to be conducted in the context of the REACH legislation and, if necessary, will reassess the safety of Climbazole.


    Keywords:

    SCCS, addendum, scientific opinion, Climbazole, preservative, P64, Regulation 1223/2009, CAS 38083-17-9, EC 253-775-4


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Addendum to the opinion on climbazole (P64) ref. SCCS/1506/13, 24-25 October 2017, SCCS/1590/17.


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  • Ethylzingerone – ‘Hydroxyethoxyphenyl Butanone’ (HEPB) (Cosmetics Europe No P98) Abstract

    SCCS/1582/16 - 23 December 2016 - Final version of 7 April 2017

    Opinion on Ethylzingerone – ‘Hydroxyethoxyphenyl Butanone’ (HEPB) (Cosmetics Europe No P98)

    Link to opinion

    WG on Cosmetic ingredients
    SCCS members: U. Bernauer (Rapporteur), L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Duus-Johansen, J. Ezendam, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
    Former SCCS members: J. van Benthem, G.H. Degen
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1582/16
    Adopted on: 7 April 2017


    Conclusion of the opinion:

    1. In light of the data provided, does the SCCS consider safe the use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products with a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics?

    Based on the information provided by the applicant, the use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products with a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics is not considered safe.
    It is of note that a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics could be considered safe if more reliable and supporting data on in vitro dermal penetration was provided.

    2. Alternatively, what is, according to the SCCS, the maximum target concentration considered safe for use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products under an aggregate exposure scenario for cosmetics?

    Based on the information provided by the applicant, a maximum concentration of 0.7 % of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products can be considered safe.

    3. Does the SCCS have any further scientific concerns regarding the use of Hydroxyethoxyphenyl Butanone (HEPB) in cosmetic products?

    The SCCS is aware that Hydroxyethoxyphenyl Butanone (HEPB) is also used as skin conditioning agent. According to the Cosmetics Regulation 1223/2009 a substance authorised as preservative at specific conditions of use (e.g. maximum concentration) can only be used for other purposes at the same conditions of use set up for the preservative function. In the specific case of Ethylzingerone, this substance cannot be used as conditioning agent at concentrations higher than that one authorised for the preservative function.


    Keywords:

    SCCS, scientific opinion, Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98, Regulation 1223/2009, CAS 569646-79-3


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98, SCCS/1582/16, 7 April 2017.


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  • Polyaminopropyl Biguanide (PHMB) - Submission III Abstract

    SCCS/1581/16 - 23 December 2016 - Final version of 7 April 2017

    Opinion on Polyaminopropyl Biguanide (PHMB) - Submission III

    Link to opinion

    WG on Cosmetic ingredients
    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Duus-Johansen, J. Ezendam, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (Rapporteur), C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1581/16
    Adopted on: 7 April 2017


    Conclusion of the opinion:

    1. In light of the new data provided, does the SCCS consider Polyaminopropyl Biguanide (PHMB) safe when used as preservative in all cosmetic products up to a maximum concentration of 0.1%?

    In the previous opinion, the SCCS stated that the Polyaminopropyl Biguanide (PHMB) is not safe up to maximal concentration of 0.3%. The safe use could be based on a lower use concentration and/or restrictions with regard to cosmetic products' categories. In order to ensure the safe use of PHMB at a lower concentration than 0.3%, the applicant presented new dermal absorption studies on additional representative cosmetic formulations.
    Based on the data provided, the SCCS is of the opinion that the use of Polyaminopropyl Biguanide (PHMB) as a preservative in all cosmetic products up to 0.1% is safe.

    2. Alternatively, taking into account the EU market data available, does the SCCS consider Polyaminopropyl Biguanide (PHMB) safe when used as preservative up to a maximum concentration of 0.1% in all cosmetic products with the exclusion of those products categories (body lotion, hand cream and oral care) in which this ingredient is seldom used?

    Not applicable.

    3. According to the data available, does the SCCS consider Polyaminopropyl Biguanide (PHMB) safe for use in sprayable formulations up to a maximum concentration of 0.1%?

    As no new safety data on inhalation is available on PHMB, its use in sprayable formulations is not advised.

    4. Does the SCCS have any further scientific concerns with regard to the use of Polyaminopropyl Biguanide (PHMB) in cosmetic products?

    /


    Keywords:

    SCCS, scientific opinion, Polyaminopropyl Biguanide (PHMB), Regulation 1223/2009, CAS 32289-58-0 / 27083-27-8 / 28757-47-3 / 133029-32-0, EC: 608-723-9 and 608-042-7


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Polyaminopropyl Biguanide (PHMB) - Submission III, SCCS/1581/16, 7 April 2017.


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  • preservative EcoG+Abstract

    SCCS/1577/16 - 16 March 2016 - Final version of 6 October 2016

    Opinion on preservative EcoG+

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, Q. Chaudhry, P. Coenraads, G. H. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, C. Rousselle, J. van Benthem
    External experts: A. Bernard, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova, E. Panteri, T. Vanhaecke
    Contact: SANCO-C2-SCCSatec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1577/16
    Adopted on: 6 October 2016


    Conclusion of the opinion:

    (1) Does SCCS consider release of silver ions from "EcoG+" as component in packaging material safe for use as preservative with a concentration of maximum 2.0 % in the cosmetic packaging material, taking into account the scientific data provided?

    Safety assessment is based on the release of silver ion from the packaging material.

    SCCS considers the release of silver ions from "EcoG+" as a component in packaging material safe for use as preservative with a concentration of maximum 2.0 % in the cosmetic packaging material.

    (2). And/or does the SCCS recommend any further restrictions with regard to the use of "EcoG+" as preservative in cosmetics packaging?

    /


    Keywords:

    SCCS, scientific opinion, preservative, EcoG+, directive 76/768/ECC, CAS 7440- 22-4, EC 231-131-3


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on preservative EcoG+, 16 March 2016, final version of 6 October 2016.


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  • PhenoxyethanolAbstract

    SCCS/1575/16 - 16 March 2016 - Final version of 6 October 2016

    Opinion on Phenoxyethanol

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members:U. Bernauer, Q. Chaudhry, P.J. Coenraads, G.H. Degen (Chairperson), M. Dusinska, W. Lilienblum (rapporteur), E. Nielsen, T. Platzek, C. Rousselle, J. van Benthem
    External experts: A. Bernard, J. Duus-Johansen, J. Ezendam, A.M. Giménez-Arnau, E. Mirkova, E. Panteri, T. Vanhaecke
    Contact: SANCO-C2-SCCSatec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1575/16
    Adopted on: 6 October 2016


    Conclusion of the opinion:

    (1)Does SCCS consider Phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0 %, taking into account the information provided?

    The SCCS considers 2-phenoxyethanol safe for use as a 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.

    The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol. Therefore, the MoS of about 50 for children also covers this specific age group who might be higher exposed to 2-phenoxyethanol than adults.

    (3) Does the SCCS have any further scientific concerns with regard to the use of Phenoxyethanol in cosmetic products?

    This Opinion does not take into account exposure from sources other than cosmetics.


    Keywords:

    SCCS, scientific opinion, Phenoxyethanol, Regulation 1223/2009, CAS No. 122-99-6, EC No. 204-589-7


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Phenoxyethanol, 16 March 2016, final version of 6 October 2016, SCCS/1575/16


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UV Filters

  • Homosalate Abstract

    SCCS/1622/20 - 24-25 June 2021

    Homosalate

    Link to opinion

    SCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1622/20
    Adopted on: 24-25 June 2021


    Conclusion of the opinion:

    1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of homosalate, does the SCCS consider homosalate safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10 %?

    On the basis of safety assessment of homosalate, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that homosalate is not safe when used as a UV-filter in cosmetic products at concentrations of up to 10%.

    2. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of homosalate as a UV-filter in cosmetic products?

    In the SCCS’s opinion, the use of homosalate as a UV filter in cosmetic products is safe for the consumer up to a maximum concentration of 0.5% homosalate in the final product.

    3. Does the SCCS have any further scientific concerns with regard to the use of homosalate in cosmetic products?

    It needs to be noted that the SCCS has regarded the currently available evidence for endocrine disrupting properties of homosalate as inconclusive, and at best equivocal. This applies to all of the available data derived from in silico modelling, in vitro tests and in vivo studies, when considered individually or taken together. The SCCS considers that, whilst there are indications from some studies to suggest that homosalate may have endocrine effects, the evidence is not conclusive enough at present to enable deriving a specific endocrine-related toxicological point of departure for use in safety assessment.

    Exposure to homosalate from other products than those in this Opinion has not been considered.

    Combined exposure to salicylic acid either formed by metabolic transformation from homosalate, other salicylates (e.g. methylsalicylate) or directly from salicylic acid itself has not been considered in this opinion.

    The use of Homosalate at the lower concentrations may have a bearing on efficacy as UV-filter, however this is outside the SCCS remit to assess the efficacy of cosmetic ingredients.


    Keywords:

    SCCS, scientific opinion, homosalate, UV-filter, Regulation 1223/2009, CAS No 118-56-9, EC No 204-260-8


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on homosalate (CAS No 118-56-9, EC No 204-260-8), preliminary version of 27-28 October 2020, final version of 24-25 June 2021, SCCS/1622/20.


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  • Octocrylene Abstract

    SCCS/1627/21 - 30-31 March 2021

    Octocrylene

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (Rapporteur), P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external expert: A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur)
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1627/21
    Adopted on: 30-31 March 2021


    Conclusion of the opinion:

    1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Octocrylene, does the SCCS consider Octocrylene safe when used as a UV-filter in cosmetic products up to a maximum concentration of 10% (as acid)?

    On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of Octocrylene, the SCCS is of the opinion that Octocrylene is safe as a UV-filter at concentrations up to 10% in cosmetic products when used individually.

    Octocrylene is also considered safe for a combined use of sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick at a concentration up to 10%. However, the use of Octocrylene at 10% or above in sunscreen propellant spray is not considered safe for the combined use.

    2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Octocrylene as a UV-filter in cosmetic products?

    The use of Octocrylene in sunscreen propellant spray is considered safe when its concentration does not exceed 9% when used together with face cream, hand cream, and lipstick containing 10% Octocrylene.

    3. Does the SCCS have any further scientific concerns with regard to the use of Octocrylene in cosmetic products?

    The SCCS considers that, whilst there are indications from some in vivo studies to suggest that Octocrylene may have endocrine effects, the evidence is not conclusive enough at present to enable deriving a specific endocrine-related toxicological point of departure for use in safety assessment. Contact sensitisation to Octocrylene has been reported, however, taking into consideration the widespread use of Octocrylene in cosmetic products, the number of reported cases of allergic contact dermatitis appears to be negligible.

    It should be noted that occurrence of photoallergy to Octocrylene is strongly related to a previous photoallergy to topical ketoprofen. Exposure to Octocrylene from other products than those in this Opinion has not been considered.

    The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Octocrylene for the environment.


    Keywords:

    SCCS, scientific opinion, Octocrylene, UV-filter, Regulation 1223/2009, CAS No 6197-30-4, EC No 228-250-8


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Octocrylene (CAS No 6197-30-4, EC No 228-250-8), preliminary version of 15 January 2021, final version of 30-31 March 2021, SCCS/1627/21.


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  • Benzophenone-3 Abstract

    SCCS/1625/20 - 30-31 March 2021

    Benzophenone-3

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (Rapporteur), P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle (Rapporteur), M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external expert: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1625/20
    Adopted on: 30-31 March 2021


    Conclusion of the opinion:

    (1) In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Benzophenone-3, does the SCCS consider Benzophenone-3 safe when used as a UV-filter in cosmetic products up to a maximum concentration of 6% and up to 0.5% in cosmetic products to protect product formulation?

    On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of benzophenone-3 (BP-3), the SCCS has concluded that:
    a. The use of BP-3 as a UV-filter up to a maximum concentration of 6% in sunscreen products, either in the form of body cream, sunscreen propellant spray or pump spray, is not safe for the consumer.
    b. The use of BP-3 as a UV-filter up to a maximum concentration of 6% in face cream, hand cream, and lipsticks is safe for the consumer.
    c. The use of BP-3 up to 0.5% in cosmetic products to protect the cosmetic formulation is safe for the consumer.

    (2) Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Benzophenone-3 as a UV-filter in cosmetic products?

    In the SCCS’s opinion, the use of BP-3 as a UV filter in the following sunscreen products is safe for the consumer up to a maximum concentration of:
    a. 2.2% in body creams, in propellant sprays and in pump sprays, provided that there is no additional use of BP-3 at 0.5% in the same formulation for protecting the cosmetic formulation.
    b. Where BP-3 is also used at 0.5% in the same formulation, the levels of BP-3 used as UV filter should not exceed 1.7% in body creams, in propellant sprays and in pump sprays.

    (3) Does the SCCS have any further scientific concerns with regard to the use of Benzophenone-3 in cosmetic products?

    It needs to be noted that the SCCS has regarded the currently available evidence for endocrine disrupting properties of BP-3 as inconclusive, and at best equivocal. This applies to all of the available data derived from in silico modelling, in vitro tests and in vivo studies, either considered individually or taken together. The SCCS considers that, whilst there are indications from some studies to suggest that BP-3 may have endocrine effects, the overall evidence is not conclusive enough at present for the SCCS to ascertain whether or not BP-3 is an ED substance, and this warrants further investigations.

    The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of BP-3 for the environment.


    Keywords:

    SCCS, scientific opinion, Benzophenone-3, UV filter, Regulation 1223/2009, CAS Number 131-57-7, EC No 205-031-5


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5), preliminary version of 15 December 2020, final version of 30-31 March 2021, SCCS/1625/20.


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  • Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) - Submission II Abstract

    SCCS/1605/19 - 13 December 2019

    Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) - Submission II

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska (Rapporteur), J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Simonnard, A. Koutsodimou, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1605/19
    Adopted on: 13 December 2019


    Conclusion of the opinion:

    (1) In light of the data provided, does the SCCS consider Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87), safe when used as UV-filter in cosmetic products up to a maximum concentration of 3%?

    Based on the data submitted, the SCCS concluded that the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87), as a UV-filter in cosmetic products up to a maximum concentration of 3%, is safe. Inhalation toxicity was not assessed in this Opinion because no data were provided. Hence, this Opinion is not applicable to any sprayable products that could lead to exposure of the consumer’s lung by inhalation.

    (2) If not, what is according to the SCCS, the maximum concentration considered safe for Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) when used as UV-filter in cosmetic products?

    /

    (3) Does the SCCS have any further scientific concerns with regard to the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) in cosmetic products?

    S87 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb.


    Keywords:

    SCCS, scientific opinion, Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87), UV-filter, Regulation 1223/2009, CAS 1419401-88-9, EC 700-860-3


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) - Submission II, preliminary version of 26 February 2019, final version of 13 December 2019, SCCS/1605/19.


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  • The safety of cosmetic ingredients Phenylene Bis-Diphenyltriazine (CAS No 55514-22-2)- S86 - Submission II Abstract

    SCCS/1594/18 - 30 July 2018

    The safety of cosmetic ingredients Phenylene Bis-Diphenyltriazine (CAS No 55514-22-2)- S86 - Submission II

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (SCCS Chair), P. Coenraads (SCCS Vice-Chair and Chairperson of the WG), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers (SCCS Vice-Chair), C. Rousselle (Rapporteur), M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Simonnard, A. Koutsodimou
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1594/18
    Adopted on: 30 July 2018


    Conclusion of the opinion:

    1. In light of the new data provided, does the SCCS consider Phenylene Bis-Diphenyltriazine, S86 safe for use as a UV-filter in sunscreen products in a concentration up to 5.0%?

    Based on the data provided in the dossier, the SCCS considers Phenylene Bis- Diphenyltriazine, S86, safe for use as a UV-filter in sunscreen products at a concentration up to 5%.

    Because of the insoluble nature of S86 and as no data were provided on safety via inhalation exposure, the SCCS considers its use safe only in dermally applied products and not in products that would lead to inhalation exposure.

    2. Does the SCCS have any further scientific concerns with regard to the use of Phenylene Bis-Diphenyltriazine, S86 as a UV-filter in sunscreen and/or other cosmetic products?

    Phenylene Bis-Diphenyltriazine (S86) may contain impurities (NMP and hydrazine), which are classified as CMR 1B and identified in the EU as SVHC. Therefore, the level of NMP and hydrazine should be kept at trace levels.

    Potential effects of Phenylene Bis-Diphenyltriazine (S86) on the environment have not been assessed by SCCS.


    Keywords:

    SCCS, scientific opinion, cosmetic ingredient Phenylene Bis-Diphenyltriazine (CAS No 55514-22-2) - S86 - Submission II, CAS 55514-22-2, EC 700-823-1, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of cosmetic ingredients Phenylene Bis-Diphenyltriazine (CAS No 55514-22-2) - S86 - Submission II, preliminary version of 21-22 February 2018, final version of 30 July 2018, SCCS/1594/18.


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  • Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) - Submission I Abstract

    SCCS/1587/17 - 7 March 2017 - Final version of 14 July 2017

    Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) - Submission I

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, C.L. Galli, B. Granum, E. Panteri (Rapporteur), V. Rogiers, C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
    Former SCCS member: J. Duus-Johansen
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1587/17
    Adopted on: 14 July 2017


    Conclusion of the opinion:

    In light of the data provided, does the SCCS consider Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87), safe when used as UV-filter in cosmetic products up to a maximum concentration of 5%?

    Based on the data provided, the SCCS is of the opinion that genotoxic potential of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) cannot be excluded. Therefore, the SCCS cannot conclude on the safety of S87. More evidence is needed to exclude the genotoxicity concern regarding S87.

    Does the SCCS have any further scientific concerns with regard to the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) in cosmetic products?

    On the basis of the studies provided, skin and eye irritation potential of the test item cannot be excluded. Dermal penetration data using 5% of the test material should also be provided.


    Keywords:

    SCCS, scientific opinion, Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87), UV-filter, Regulation 1223/2009, CAS 1419401-88-9, EC 700-860-3


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) - Submission I, preliminary version of 7 March 2017, final version of 14 July 2017, SCCS/1587/17.


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Others

  • Scientific Advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances Abstract

    SCCS/1632/21 - 7 May 2021

    Scientific Advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external expert: A. Koutsodimou, W. Uter (Rapporteur), N. Von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1632/21
    Adopted on: 7 May 2021


    Conclusion of the opinion:

    1. In light of the data provided and taking under consideration the available scientific literature, does the SCCS consider the 0.05% threshold for labelling formaldehyde releasing substances adequate to protect consumers?

    The SCCS considers that the present threshold does not sufficiently protect consumers sensitised to formaldehyde from exposure to free formaldehyde from formaldehyde releasers.

    2. Does the SCCS consider necessary to change the 0.05% threshold and at which level?

    Reducing the present threshold by a factor of 50, that is, to 0.001% (10 ppm), will protect the vast majority of consumers sensitised to formaldehyde. This threshold applies to the total free formaldehyde irrespective of whether a product contains one or more formaldehyde releaser(s).


    Keywords:

    SCCS, scientific advice, formaldehyde, Regulation 1223/2009, CAS No. 50-00-0, EC No. 200-001-8, SCCS/1632/21


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Scientific advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances, final version of 7 May 2021, SCCS/1632/21.


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  • Addendum to the scientific opinion SCCS/1613/19 on the safety of aluminium in cosmetic products (lipstick) - Submission II Abstract

    SCCS/1626/20 - 30-31 March 2021

    Addendum to the scientific opinion SCCS/1613/19 on the safety of aluminium in cosmetic products (lipstick) - Submission II

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external expert: A. Koutsodimou, W. Uter, N. Von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1626/20
    Adopted on: 30-31 March 2021


    Conclusion of the opinion:

    1. In light of the new data provided, does the SCCS consider Aluminium safe when used in lipsticks up to a maximum concentration of 14%? In the event that the estimated exposure to Aluminium from lipsticks of cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits.

    In the light of the new data provided, the SCCS considers that the use of aluminium compounds is safe at the following equivalent aluminium concentrations up to:
    · 6.25% in non-spray deodorants or non-spray antiperspirants
    · 10.60% in spray deodorants or spray antiperspirants
    · 2.65% in toothpaste and
    · 14% in lipstick

    2. Does the SCCS have any further scientific concerns regarding the use of Aluminium substances in cosmetic products taking into account the newly submitted information on aggregate exposure from cosmetics?

    The SCCS considers that the systemic exposure to aluminium via daily applications of cosmetic products does not add significantly to the systemic body burden of aluminium from other sources. Exposure to aluminium may also occur from sources other than cosmetic products, and a major source of aluminium in the population is the diet. This assessment has not taken into account the daily dietary intake of aluminium.


    Keywords:

    SCCS, scientific opinion, aluminium, addendum, lipstick, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Addendum to the scientific opinion SCCS/1613/19 on the safety of aluminium in cosmetic products - Submission II, preliminary version of 15 December 2020, final version of 30-31 March 2021, SCCS/1626/20.


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  • The safety of presence of Bisphenol A in clothing articles Abstract

    SCCS/1620/20 - 30-31 March 2021

    The safety of presence of Bisphenol A in clothing articles

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke (Rapporteur), S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1620/20
    Adopted on: 30-31 March 2021


    Conclusion of the opinion:

    1. To review the available data on the presence and activity of Bisphenol A in clothing articles, taking into consideration the adopted opinions on tolerable intake limits and the legislative framework in other products (food contact materials, toys and printed paper)

    Regarding potential health effects of BPA, this Opinion is based on the information present in the most recent health risk assessments conducted by EFSA (2015) and ECHA (2015). SCCS is, however, aware of the fact that EFSA is currently re-evaluating the huge amount of data on BPA toxicity that came available since December 2012, i.e. the cut-off point for their latest assessment published in 2015. Hence, all outcomes and conclusions reported in this document with respect to human health might be subject of change in the near future. If this is the case, the Opinion should be updated accordingly.

    Exposure to BPA may occur from various sources, both dietary and non-dietary. In this Opinion, the assessment is based only on one source of BPA (i.e. textiles) and does not take into account the contribution of other sources, nor does it apply to BPA analogues.

    Only one study provides experimental migration rates of BPA from clothing into artificial sweat (Wang et al. 2019). Based on these reported migration rates, migration fractions were calculated under conservative assumptions, with a 2-hour chronic daily contact of the whole trunk to clothes fully soaked in sweat for men and women. As for children, exposure to sweaty clothes was considered with additional oral exposure due to sucking on clothes. From these calculations, it can be estimated that for adults the internal total BPA exposure due to clothing is between 1.56 - 9.90 ng/kg bw/d. For toddlers, exposure to total BPA via clothing is higher i.e. between 2.37 – 14.8 ng/kg bw/d. Compared to the dietary exposure previously assessed by EFSA (2015), the exposure to BPA through clothing is at least 25 times lower. Due to the many upper bound scenario decisions made in the exposure assessment, this difference may be much larger in reality. Moreover, taking into account that Wang et al. (2019) is the only study as yet available for BPA migration rates from clothes and that very large migration fractions have been determined, it has to be confirmed that migration of BPA from clothes is really that high. In future studies, reproducibility of the migration experiment should be investigated, and time-dependent and fabric-specific migration rates derived.

    2. To determine whether the exposure levels to BPA due to the use of clothing articles raises health concerns for consumers and, if possible, to provide indications on limit values for BPA content/release from clothing articles.

    For the following scenario considered for adults and toddlers, the MoS is 1406 and 931, respectively. Hence, there is no risk for adverse effects of the estimated exposure levels of BPA resulting from the use of clothes, independent of the age group of the consumer. BPA has been detected in clothing articles and taken into account its hazard profile, this might be of concern as clothing articles are in direct and prolonged contact with the skin. Moreover, in case of young children, oral exposure due to sucking on clothes can contribute to total BPA exposure.

    All clothing exposure scenarios analysed in this Opinion result in an exposure level of BPA that is below the t-TDI of 4 μg/kg bw/d based on increased kidney weight in a 2-year generation study in mice as critical endpoint with a BMDL10 of 8.96 mg/kg bw/d. However, regarding the dermal exposure via clothing, it is necessary to take into account the huge difference in dermal bioavailability of parent BPA when compared to the oral route. Therefore, the SCCS considered it appropriate to follow a MoS approach and to make the comparison using an internal HED (HEDi, 6.09 μg/kg bw/d when assuming 1 % free BPA after uptake by the oral route) rather than the external HED value. From a conservative point of view, SCCS further decided not to consider skin metabolism.

    Furthermore, using a surface weight of 0.013 g/cm2 textile and a migration fraction of 0.085 (1/d) derived from the experimental BPA migration rates from sweaty clothes by Wang et al. (2019), a maximum amount of BPA of around 0.8 mg/kg textile could be established via back calculations to protect against systemic effects that BPA may exert in humans when present in clothing.

    However, a major source of uncertainty in the determination of the limit value for BPA in clothing articles is that only one study is available that reports BPA-specific migration rates. The migration fractions derived from these migration rates are particularly large compared to previously determined, non-specific, migration fractions (BfR 2012; Kraetke and Platzek 2004). It is therefore essential to confirm the findings by Wang et al. (2019) before advising on limit values of BPA in clothing. Even though it may be possible to establish limit values based on the data available, the reliability remains unknown until additional research becomes available.

    3. To identify whether vulnerable consumers such as infants and young children (who might put such articles in their mouth) or pregnant women are in particular risk. On the basis of the risk assessment, could it be indicated what level of exposure to BPA from textiles can be accepted in such groups.

    Based on the conservative BPA exposure estimates identified in this Opinion for adults and toddlers, there is no risk for systemic health effects due to the use of clothing articles. This also applies for young children as, compared to toddlers, less mouthing of textiles would result even in decreased oral exposure, and therefore overall BPA exposure.

    In the present Opinion, the SCCS relies on the same PoD for risk assessment, as used by EFSA to set the t-TDI. This PoD results from a two-generation study in mice, and therefore covers more vulnerable windows of susceptibility in the population such as pregnancy and perinatality. Therefore, SCCS considers that vulnerable consumers have been properly addressed in this assessment.


    Keywords:

    SCCS, scientific opinion, Bisphenol A, clothing, 2,2-bis(4-hydroxyphenyl)propane, CAS Number 80-05-7, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of the presence of Bisphenol A in clothing articles - 2,2-bis(4-hydroxyphenyl)propane (CAS Number 80-05-7), preliminary version of 16 October 2020, final version of 30-31 March 2021, SCCS/1620/20.


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  • Titanium dioxide (TiO2) used in cosmetic products that lead to exposure by inhalation Abstract

    SCCS/1617/20 - 6 October 2020

    Titanium dioxide (TiO2) used in cosmetic products that lead to exposure by inhalation

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven (Rapporteur)
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1617/20
    Adopted on: 6 October 2020


    Conclusion of the opinion:

    1. In light of the data provided and of the possible classification as Carcinogen Cat. 2 (inhalation) in Annex VI to Regulation (EC) n.1272/2008, does the SCCS consider Titanium dioxide safe when used as a UV-filter (entry 27 Annex VI) in cosmetic products up to a maximum concentration of 25 %, as a colorant (entry 143 Annex IV) and as an ingredient in all other cosmetic products?

    On the basis of safety assessment, the SCCS is of the opinion that the use of pigmentary titanium dioxide (TiO2) up to a maximum concentration of 25% in a typical hair styling aerosol spray product is not safe for either general consumers or hairdressers.

    The safety assessment has shown that the use of pigmentary TiO2 in loose powder up to a maximum concentration of 25% in a typical face make-up application is safe for the general consumer.

    It needs to be noted that these conclusions are based on safety assessment of TiO2 in the context of possible classification as category-2 carcinogen (via inhalation). This means that the conclusions drawn in this Opinion are applicable to the use of pigmentary TiO2 in a cosmetic product that may give rise to consumer exposure by the inhalation route (i.e. aerosol, spray and powder form products). As such, the Opinion is not applicable to any pearlescent pigment because of the composite nature of such materials, of which TiO2 is only a minor constituent.

    2. Alternatively, if up to 25% use is not considered safe, what is according to the SCCS, the maximum concentration considered safe for use of Titanium dioxide as an ingredient in cosmetic products?

    In the SCCS’s opinion, the use of pigmentary TiO2 in a typical hair styling aerosol spray product is safe up to a maximum concentration of 1.4 % for general consumers, and 1.1 % for hairdressers.

    3. Does the SCCS have any further scientific concerns with regard to the use of Titanium dioxide in cosmetic products?

    It needs to be emphasised that the SCCS conclusions have been drawn from a very selected group of cosmetic products based on only one type of TiO2 material (pigmentary, anatase, surface-treated). In the absence of more information, it may not be clear whether these conclusions would be applicable to the use of pigmentary TiO2 materials in other similar types of cosmetic applications that may be on the market. In this regard, the SCCS is of the opinion that other applications of pigmentary TiO2 materials can also be considered safe if the MoS calculation is performed as detailed in the current Opinion, and if the resultant MoS for the combined use of different products is above 25 for general consumers and for hairdressers.


    Keywords:

    SCCS, scientific opinion, Titanium dioxide (TiO2), Regulation 1223/2009, CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/215-280-1, 1317-80-2/215-282-2


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Titanium dioxide (TiO2), preliminary version of 7 August 2020, final version of 6 October 2020, SCCS/1617/20.


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  • The safety of Aluminium in cosmetic products - Submission II Abstract

    SCCS/1613/19 - 03-04 March 2020

    The safety of Aluminium in cosmetic products - Submission II

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin (Rapporteur), Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1613/19
    Adopted on: 03-04 March 2020


    Conclusion of the opinion:

    1. In light of the new data provided, does the SCCS consider that Aluminium compounds are safe in
    • Antiperspirants,
    • Other cosmetic products such as lipsticks and toothpastes?

    In the light of the new data provided, the SCCS considers that the use of aluminium compounds is safe at the following equivalent aluminium concentrations up to:
    · 6.25% in non-spray deodorants or non-spray antiperspirants
    · 10.60% in spray deodorants or spray antiperspirants
    · 2.65% in toothpaste and
    · 0.77 % in lipstick

    2. Does the SCCS have any further scientific concerns regarding the use of Aluminium compounds in cosmetic products taking into account exposure from other sources?

    The SCCS considers that the systemic exposure to aluminium via daily applications of cosmetic products does not add significantly to the systemic body burden of aluminium from other sources. Exposure to aluminium may also occur from sources other than cosmetic products, and a major source of aluminium in the population is the diet. This assessment has not taken into account the daily dietary intake of aluminium.

    3. In the event that the estimated exposure to Aluminium from specific types of cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for the presence of Aluminium in those cosmetic products or other risk reducing measures.

    /


    Keywords:

    SCCS, scientific opinion, Aluminium, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products, preliminary version of 30-31 October 2019, final version of 03-04 March 2020, SCCS/1613/19.


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  • Salicylic acid (CAS 69-72-7) - Submission I Abstract

    SCCS/1601/18 - 21 December 2018
    Corrigendum of 20-21 June 2019

    Salicylic acid (CAS 69-72-7) - Submission I

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri (Rapporteur), V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Simonnard, A. Koutsodimou, W. Uter
    Acknowledgements: N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1601/18
    Adopted on: 21 December 2018


    Conclusion of the opinion:

    1. In light of the new data provided, does the SCCS still consider Salicylic acid (CAS 69-72-7) safe when used as a preservative in all cosmetic products up to a maximum concentration of 0.5% (acid) considering its current restriction as reported above?

    The SCCS considers salicylic acid (CAS 69-72-7) safe when used as preservative at a concentration of 0.5 % in cosmetic products considering its current restrictions in place.
    This Opinion is not applicable to any oral product (such as toothpaste and mouthwash) with the exception of lipsticks. Sprayable products that could lead to exposure of the consumer’s lung by inhalation are also excluded. The provided information shows that salicylic acid is an eye irritant with the potential to cause serious damage to the eye.

    2. In addition, does the SCCS still consider Salicylic acid (CAS 69-72-7) safe when used for purposes other than inhibiting the development of micro-organisms at a concentration up to 3.0 % for the cosmetic rinse-off hair products and up to 2.0 % for other products considering its current restrictions as reported above?

    Based on the data provided and available literature, the SCCS considers salicylic acid (CAS 69-72-7) safe when used for purposes other than preservative at a concentration up to 3.0 % for the cosmetic rinse-off hair products and up to 2.0 % for other products, considering its current restrictions in place. However, in body lotion, eye shadow, mascara, eyeliner, lipstick and roll on deodorant applications, salicylic acid is considered safe up to 0.5 %. The SCCS position is that these levels are inclusive of any use of salicylic acid, i.e. should not exceed the stated levels with additional use as a preservative.
    This Opinion is not applicable to any oral product (such as toothpaste and mouthwash) with the exception of lipsticks. Sprayable products that could lead to exposure of the consumer’s lung by inhalation are also excluded.

    3. Does the SCCS have any further scientific concerns with regard to the use of Salicylic acid (CAS 69-72-7) in cosmetic products?

    Salicylic acid is also used as a preservative in food and as a biocide in some consumer products (see section 3.2.3) or in various pharmaceutical formulations such as anti-acne products. As no specific exposure data were made available to SCCS to assess exposure following these non-cosmetic uses, it was not possible to include them in the aggregated exposure scenarios. Therefore, the actual total exposure of the consumer may be higher than exposure from cosmetic products alone. The conclusions of this Opinion refer only to Salicylic Acid and should not be applied to other salicylates or salicylic acid salts.


    Keywords:

    SCCS, scientific opinion, salicylic acid, Regulation 1223/2009, CAS 69-72-7, EC 200-712-3, SCCS/1601/18


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on salicylic acid (CAS 69-72-7) - Submission I, SCCS/1601/18, preliminary version of 10 September 2018, final version of 21 December 2018, CORRIGENDUM on 20-21 June 2019.


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  • The safety of cosmetic ingredients HEMA and Di-HEMA Trimethylhexyl Dicarbamate - Submission I Abstract

    SCCS/1592/17 - 21-22 June 2018

    The safety of cosmetic ingredients HEMA and Di-HEMA Trimethylhexyl Dicarbamate - Submission I

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, L. Celleno (Rapporteur), Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1592/17
    Adopted on: 21-22 June 2018


    Conclusion of the opinion:

    1. In light of the data provided, does the SCCS consider monomers of HEMA and Di-HEMA Trimethylhexyl Dicarbamate, safe at concentrations of up to 35% and 99% respectively when used in topically applied UV-cured artificial nail modelling systems?

    The available evidence suggests that normal nail plate acts as a good barrier to penetration of chemical substances in general, and that both methacrylate monomers (HEMA and di-HEMA-TMHDC) polymerise rapidly under UV curing when applied as part of an artificial nail modelling system. This leaves very little chance for the monomers to be absorbed in any appreciable amount through the nail plate. In view of this, the SCCS is of the opinion that HEMA and di-HEMA-TMHDC, when applied appropriately to the nail plate at concentrations of up to 35% and 99% respectively as part of an artificial nail modelling system, are not likely to pose a risk of sensitisation, provided that their use is restricted to the nail plate only and contact with the adjacent skin is avoided.

    2. Does the SCCS have any further scientific concerns with regard to the use of HEMA and Di-HEMA Trimethylhexyl Dicarbamate monomers in cosmetic products?

    - More analytical data are needed to exclude the possibility of the presence of other sensitisers that may be present as impurities or degradation products alongside the two methacrylate monomers.

    - Both HEMA and di-HEMA-TMHDC are weak to moderate sensitisers and pose a risk of sensitisation from misuse of the products or from inappropriately carried out application or from unintentional contamination of the skin adjacent to the nails under normal and reasonably foreseeable conditions of use.

    - Filing or sanding nails to remove/replace previous applications may generate particle dust that may lead to respiratory exposure of the professionals if appropriate protective measures are not in place.

    - The potential for sensitisation to the methacrylate monomers is likely to be higher amongst the professionals who carry out routine applications of artificial nail modelling systems without appropriate protective measures.

    - In view of the growing popularity of artificial nail fashions and the potential use by consumers at home, and considering the observations of several professional dermatological organisations that the prevalence of contact dermatitis from artificial nail products (among which HEMA is an important constituent) is rising, a further increase of the prevalence of sensitisation is possible.


    Keywords:

    SCCS, scientific opinion, cosmetic ingredients, 2-hydroxyethyl methacrylate HEMA (CAS 868-77-9 and EC 212-782-2), Di-HEMA Trimethylhexyl Dicarbamate (CAS 41137-60-4 / 72869-86-4 and EC 276-957-5), SCCS/1592/17, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of cosmetic ingredients HEMA (CAS 868-77-9) and Di-HEMA Trimethylhexyl Dicarbamate (CAS 41137-60-4 / 72869-86-4) - Submission I (Sensitisation only), SCCS/1592/17, preliminary version adopted on 22 December 2017, final version adopted on 21-22 June 2018.


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  • Water-soluble zinc salts used in oral hygiene products - Submission I Abstract

    SCCS/1586/17 - 21-22 June 2018

    Water-soluble zinc salts used in oral hygiene products - Submission I

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam, C.L. Galli, B. Granum (Rapporteur), E. Panteri, V. Rogiers, C. Rousselle, M. Stępnik, T. Vanhaecke, S. Wijnhoven
    Former SCCS member: J. Duus-Johansen
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1586/17
    Adopted on: 21-22 June 2018


    Conclusion of the opinion:

    1. According to the data available, does the SCCS consider water soluble Zinc salts safe for all age groups at the current allowed concentration of up to 1% as Zinc when used in toothpastes and at the use level of up to 0.1% as Zinc when used in mouthwashes?

    The SCCS has estimated that exposure to water-soluble zinc salts via toothpaste and mouthwash at the concentrations of 1 and 0.1%, respectively, may lead to a daily intake level of 3.54 mg for adults and children aged 6-17 years. This exposure constitutes between 14 and 35% of the Upper Limit (UL) for these age groups. Therefore, the SCCS considers that the use of zinc in toothpaste and mouthwash per se is safe for adults and children aged 6-17 years.

    The SCCS has estimated that exposure to water-soluble zinc salts via toothpaste at the concentrations of 1% may lead to a daily intake level of 1.0-2.00 mg for children aged 0.5-5 years. This exposure constitutes between 10 and 29% of the UL for this age group. Therefore, the SCCS considers that the use of zinc in toothpaste per se is safe for children aged 0.5-5 years.

    2. Does the SCCS have any concerns related to the use of water-soluble Zinc salts in oral products for the particular age group 1 to 17-year old?

    Exposure to zinc may also occur from sources other than oral hygiene products. An important source of zinc in the population is the diet. This assessment has not taken into account the daily dietary intake of zinc.

    The dietary zinc intake (estimated by EFSA in 2014) ranges from 6.8 to 14.5 mg/day in adolescents aged 10 to < 18 years, from 5.5 to 9.3 mg/day in children aged 3 to < 10 years and from 4.6 to 6.2 mg/day in children aged 1 to <3 years. Therefore, exposure to zinc via the diet may already exceed or be close to exceeding the upper limits of 18, 13, 10 and 7 mg/day for the age groups 11-14, 7-10, 3-7 and 1-3 years, respectively. Any additional source of exposure, including cosmetics, may lead to exceeding the upper limits for children.

    The SCCS cannot advise which portion of the upper limit should be allocated to exposure from cosmetic products. When assessing exposure to chemicals, allocation factors that reflect a reasonable level of exposure while still being protective may be applied. For exposure via toys or drinking water, for example, allocation factors of 10% or 20% of the reference value may be considered as safe. In the case of zinc, the use of 1% in toothpaste and 0.1% in mouthwash constitutes between 10 and 35% of the upper limit depending on the age group. The SCCS is aware that upper limits may be exceeded in some cases because the default values used in this Opinion are based on conservative estimates.


    Keywords:

    SCCS, scientific opinion, water-soluble zinc salts, oral hygiene products, zinc acetate CAS: 557-34-6 EC: 209-170-2, zinc chloride CAS: 7646-85-7 EC: 231-592-0, zinc gluconate CAS: 4468-02-4 EC:/, zinc citrate CAS: 546-46-3 EC:/, zinc sulphate/zinc sulphate monohydrate/zinc sulphate heptahydrate CAS: 7733-02-0/7446-19-7/7446-20-0 EC:/, SCCS/1586/17, Regulation 1223/2009


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on watersoluble zinc salts used in oral hygiene products - Submission I, preliminary version adopted on 7 March 2017, final version adopted on 21-22 June 2018, SCCS/1586/17.


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  • Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)Abstract

    SCCS/1576/16 - 20 April 2016 - Final version of 6 October 2016
    Corrigendum 23 December 2016

    Opinion on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)

    Link to opinion

    WG on Cosmetic Ingredients
    SCCS members: U. Bernauer, Q. Chaudhry, P. Coenraads, G. H. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, C. Rousselle, J. van Benthem
    External experts: A. Bernard, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova, E. Panteri, T. Vanhaecke
    Contact: SANCO-C2-SCCSatec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1576/16
    Adopted on: 6 October 2016


    Conclusion of the opinion:

    (1) On the basis of data provided does the Scientific Committee on Consumer Safety (SCCS) consider Vitamin A (retinol, retinyl palmitate, and retinyl acetate,) safe when used as cosmetic ingredient:

    (a) in body lotions up to the maximum concentration of 0.05 % of retinol equivalent?

    The SCCS has estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate) via body lotion at the maximum concentration of 0.05% may lead to a daily systemic dose of 1003 IU for an adult. This exposure would constitute up to 20% of the Upper Limit (UL) of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in body lotions per se is safe.

    (b) in hand/face cream, leave-on (other than body lotions) and rinse-off products up to the concentration of 0.3 % of retinol equivalent?

    The SCCS has estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate):

    - via hand cream at the maximum concentration of 0.3% may lead to daily systemic dose of 1661 IU for an adult. This exposure could constitute up to 33% of the UL of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in hand cream products per se is safe.

    - via face cream at the maximum concentration of 0.3% may lead to daily systemic dose of 1185 IU for an adult. This exposure could constitute up to 24% of the UL of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in face cream products per se is safe.

    - via rinse-off products at the maximum concentration of 0.3% may lead to a daily systemic dose of 408 IU for an adult. This exposure could constitute up to 8.8% of the UL of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in rinse-off products per se is safe.

    The SCCS has also estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate) from all cosmetic products (including lip products) may lead to a daily systemic dose of 4855 IU for an adult. This exposure could constitute up to 97% of the UL of 5000 IU/day of Vitamin A. Excluding lip products, the daily systemic dose is estimated at 4256 IU for an adult, which constitutes up to 85% of the UL of 5000 IU/day of Vitamin A.

    It is of note that these estimates are based on a worst-case scenario assuming that all the cosmetic products used (hand and face cream, body lotion, rinse-off products, products for the lips) contain Vitamin A at the maximum concentrations.

    If no, what concentration limits in the above mentioned categories of cosmetic products does the SCCS consider Vitamin A to be safe?

    /

    (2) The SCCS is asked, when making the assessment, to take into account the specific age and sex groups who might be particularly susceptible to the effects of Vitamin A, such as the use of lip products for fertile age and postmenopausal women.

    The SCCS has considered that the teratogenic potential of Vitamin A, and effects on liver and local effects in the skin are the most critical toxicological endpoints. For assessing the systemic toxicity of Vitamin A after cosmetic exposure, the SCCS has relied on the Tolerable Upper Intake Level (UL) for preformed Vitamin A (section 3.4.4).

    - To take into account more susceptible population groups such as women suffering osteoporosis or children above 6 years old who may also be exposed to Vitamin A via cosmetic products, the SCCS has used the value of 1500 μg RE/day (5000 IU) for the safety assessment of Vitamin A in cosmetic products. This value is appropriate for women of childbearing age and also for middle age and elderly women who may suffer decreasing bone density as well as men and children above 6 years. Based on information provided by the cosmetic industry, Vitamin A and esters are not used for children in the EU. However, based on a theoretical scenario, exposure to Vitamin A via these products has been assessed in this opinion for children above 1 year.

    - The SCCS has used the value of 800 μg RE/day (2700 IU) for the safety assessment of Vitamin A in cosmetic products for children aged 1-3 years. Application of Vitamin Acontaining baby skin care products such as body lotions and creams were also considered by SCCS relevant for 1- and 3-years old children. The SCCS has estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate) via all cosmetic products may lead to a daily systemic dose of 1064 IU for a child of 15 kg. This exposure could constitute up to 39% of the UL of 2700 IU/day of Vitamin A.

    It is of note that these estimates are based on a worst-case scenario assuming that all the cosmetic products used (hand and face cream, body lotion, rinse-off products) contain Vitamin A at the maximum concentrations. Based on these estimates, the SCCS considers that the use of Vitamin A in the respective cosmetic products at the maximum notified concentration per se is safe for children above 1 year old.

    (3) Does the SCCS have any further scientific concerns with regard to the use of Vitamin A (retinol, retinyl palmitate, and retinyl acetate,) in cosmetic products?

    - Based on information provided by the applicants, Vitamin A and esters are not used in sunscreen products in the EU. Therefore exposure to Vitamin A via these products has not been assessed in this Opinion.

    Based on information provided by the cosmetic industry, Vitamin A and esters are not used for children in the EU. However, application of Vitamin A-containing baby skin care products, such as body lotions and creams, were considered by the SCCS safe for 1- and 3-year old children. Exposure to Vitamin A via these products for children below 1 year has not been assessed in this Opinion.

    - Retinyl linoleate and retinal may also be used in cosmetic products. However, since no specific data were provided by the applicant, these two Vitamin A derivatives have not been assessed in this Opinion.

    - Exposure to Vitamin A may also occur from sources other than cosmetic products. The most important source of Vitamin A in the population is diet, followed by food supplements and cosmetics. This assessment has not taken into account people taking dietary supplement containing Vitamin A.

    - On the basis of data from 12 dietary surveys in nine EU countries, Vitamin A intake was assessed and average intake ranged between 409 and 651 μg RE/day in children aged 1 to < 3 years; between 607 and 889 μg RE/day in children aged 3 to < 10 years; between 597 and 1 078 μg RE/day in children aged 10 to < 18 years; and between 816 and 1498 μg RE/day in adults. Therefore exposure to Vitamin A via food may already be very close to the UL and any additional source of exposure, including cosmetic products, may exceed this UL. It is however not up to the SCCS to advise which portion of the UL should be dedicated to the different sources of exposure. For example, when assessing exposure to chemicals via toys or drinking water, usually 10% or 20% of the reference value is considered. In the case of Vitamin A, these portions would be equivalent to 150 or 300 μg RE/day, which means that at the maximum-notified concentrations, the use of hand and face cream products, rinse-off products, body lotion and cosmetic products for lips may lead to exceeding this value.

    - No information for the determination of impurities was provided for retinol, retinyl acetate and retinol palmitate. Since the use of retinoic acid in cosmetic products is banned in the EU (Annex 2, entry 375), the applicant should provide information on this particular impurity.

    - No data are available on the stability of Vitamin A in different product formulations. The use of retinol in cosmetic products will need to be stabilised through final formulations.


    Keywords:

    SCCS, scientific opinion, Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate), Regulation 1223/2009, CAS n. 11103-57-4 / 68-26-8 / 127-47-9 / 79-81-2, EC 234-328-2 / 200-683-7 / 204-844-2 / 201-228-5


    Opinion to be cited as:

    Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate), SCCS/1576/16, 20 April 2016, final version of 6 October 2016.


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  • Decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic productsAbstract

    SCCS/1549/15 - 25 March 2015 - Final version of 29 July 2016

    Decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic products

    Link to opinion

    SCCS members: U. Bernauer, P. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, S. C. Rastogi, Ch. Rousselle, Ja. van Benthem
    External experts: A. Bernard, A. Giménez-Arnau, T. Vanhaecke
    Contact:SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1549/15
    Adopted on: 25 March 2015 - Final version of 29 July 2016


    Conclusion of the opinion:

    (1) On the basis of the data provided does the Scientific Committee on Consumer Safety (SCCS) consider Cyclopentasiloxane (D5) safe as cosmetic ingredient?

    The SCCS considers that the use of Cyclopentasiloxane (D5) in cosmetic products is safe at the reported concentrations, except for use in hair styling aerosols and sun care spray products. Indeed, for these products, at the maximal concentrations declared by the applicant and based on the hypothesis retained by SCCS, exposure to D5 may lead to air concentrations above the value where SCCS considered that D5 may be aerosolized and locally toxic. Exposure to D5 coming from hair styling spray products also triggers high level of aggregated exposure which may also lead to concentrations in the air above the value considered safe by the SCCS.

    This opinion does not cover the use of Cyclopentasiloxane (D5) in oral care products.

    (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?

    Cyclopentasiloxane (D5) may contain traces of Cyclotetrasiloxane (D4) which is classified in the EU as toxic to reproduction. Therefore, the level of impurity of Cyclotetrasiloxane (D4) as an impurity of Cyclopentasiloxane (D5) should be kept as low as possible.

    SCCS is aware that restrictions on D4 and D5 in personal care products have been proposed under Reach regulation due to environmental issue.

    This opinion did not address the potential impact of D5 on the environment.


    Keywords:

    SCCS, scientific opinion, decamethylcyclopentasiloxane (cyclopentasiloxane, D5), Regulation 1223/2009, CAS n. 541-02-6, EC number 208-764-9


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on decamethylcyclopentasiloxane (cyclopentasiloxane, D5) in cosmetic products, SCCS/1549/15, 25 March 2015, final version of 29 July 2016.


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Methodologies

  • Allergy Alert Test (AAT) as a proof-of-concept study Abstract

    SCCS/1607/19 - 10 May 2019 - Final version of 10 September 2019

    Allergy Alert Test (AAT) as a proof-of-concept study

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter (Rapporteur)
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1607/19
    Adopted on: 10 September 2019


    Conclusion of the opinion:

    1. In light of the study provided and the SCCP/1104/07 opinion, does the SCCS consider the new harmonized Allergy Alert Test (AAT), with the conditions listed above, a suitable test to provide a signal indicative of an allergic reaction to hair dyes when used by laypersons?

    The SCCS acknowledges the standardisation of the allergy test offered by the proposed AAT as a prerequisite for possible future use of such a test by consumers. Within the precision limits of the study, it has been demonstrated that the rating of the test results by a well-informed layperson corresponds well with that of a dermatology expert. However, as the study participants may have constituted a selective, more educated, or motivated subset of the general user population, the effectiveness of the test in terms of general applicability to all consumers still needs to be demonstrated.

    The diagnostic performance indicates a very good specificity, but a potentially moderate sensitivity, leaving room for the possibility of false-negative AAT reactions in sensitised consumers who may then experience allergic contact dermatitis to a subsequently applied product.

    In addition, the results provided by the study can only partly enable assessment of the benefit and risk of the AAT for the consumers, and the SCCS cannot, at this stage, endorse the use of the AAT as an “alert” for contact allergy to hair dyes in consumers.

    2. Does the SCCS have any further scientific concerns regarding the AAT?

    The SCCS reiterates the concern expressed in the previous Opinion (SCCP/1104/07) that the AAT carries the same basic risk of sensitisation as the use of a hair dye product by a consumer. If the AAT is used on a regular basis before hair dyeing, it will inevitably increase the number of exposures, and this may increase the risk of sensitisation.

    The SCCS would also like to reiterate from the previous Opinion SCCP/1104/07 to point out that the use of hair dye products on the skin and for in vivo diagnostic purposes is not covered by the Cosmetics Regulation. In this regard, the development and scientific evaluation of other screening methods for hair dye sensitisation (e.g. through a suitable, validated questionnaire) should be considered.


    Keywords:

    SCCS, scientific opinion, Allergy Alert Test, AAT, proof-of-concept study, Regulation 1223/2009, SCCS/1607/19


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Allergy Alert Test (AAT) as a proof-of-concept study, preliminary version of 10 May 2019, final version of 10 September 2019, SCCS/1607/19.


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  • Skin Sensitisation Quantitative Risk Assessment for Fragrance Ingredients (QRA2) - Submission I Abstract

    SCCS/1589/17 - 24-25 October 2017 - Final version of 30 July 2018

    Skin Sensitisation Quantitative Risk Assessment for Fragrance Ingredients (QRA2) - Submission I

    Link to opinion

    WG on Methodologies
    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    External experts: A. Simonnard, N. von Goetz, W. Uter
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1589/17
    Adopted on: 30 July 2018


    Conclusion of the opinion:

    In light of the methodology provided, does the SCCS consider QRA2 adequate to establish a concentration at which induction of sensitisation by a fragrance ingredient unlikely to occur?

    The "QRA2 final report" together with the supplementary information received shows that a lot of progress has been achieved since the initial publication of the QRA. However, it is not yet possible to use the QRA2 to establish a concentration at which induction of sensitisation of fragrance is unlikely to occur. Several aspects of the methodology are not clear and the scientific rationale behind the methodology needs to be better described. These aspects have been highlighted in this Opinion.

    Does the SCCS have any further scientific comments with regard to the use of QRA2 methodology to determine, in particular regarding applicability, development and improvements?

    A number of additional considerations and refinements have been incorporated to the proposed methodology. However, explanation of certain methodological approaches and assumptions, as well as a description of uncertainties is lacking, the provision of which would enhance understanding of the methodology. These aspects have been highlighted in the SCCS comments under each section with the aim to provide pointers for improvement. If shaped up properly, this could be a useful methodology not only for risk assessment of fragrance allergens, but potentially also for other cosmetic ingredients.


    Keywords:

    SCCS, scientific opinion, Skin Sensitisation Quantitative Risk Assessment for Fragrance Ingredients (QRA2), Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Opinion on Skin Sensitisation Quantitative Risk Assessment for Fragrance Ingredients (QRA2), preliminary version of 24-25 October 2017, final version of 30 July 2018, SCCS/1589/17.


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Statements/Guidances

  • SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation - 11th revisionAbstract

    SCCS/1628/21 - 30-31 March 2021

    SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation - 11th revision

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (SCCS Chair), P. Coenraads (SCCS Vice-Chair), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers (SCCS Vice-Chair and rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1628/21
    Adopted on: 30-31 March 2021


    Background:

    The “Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation by the SCCS” is a document compiled by the members of the Scientific Committee on Consumer Safety (SCCS, replacing the former SCCP, SCCNFP and SCC). The document contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of this guidance is on cosmetic ingredients, although some guidance is also indirectly given for the safety assessment of finished products. It is designed to provide guidance to public authorities and to the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation. An important development in recent years was the full implementation of the cosmetic legislation, Regulation (EC) No 1223/2009, meaning that the animal testing and marketing bans fully apply from 2013 onwards: no in vivo testing of finished products after 11 March 2004; no in vivo testing for local toxicity after 11 March 2009 and no in vivo testing for repeated dose toxicity (including sensitisation) toxicokinetics and developmental toxicity from 11 March 2013 onwards for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made with regard to the development and validation of alternative methods, with emphasis on replacement methodology.

    The "Notes of Guidance" are regularly revised and updated in order to incorporate the progress of scientific knowledge in general, and the experience gained, in particular in the field of testing and safety evaluation of cosmetic ingredients.


    Keywords:

    SCCS, SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, SCCS/1628/21


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 11th revision, 30-31 March 2021, SCCS/1628/21.


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  • Guidance on the safety assessment of nanomaterials in cosmeticsAbstract

    SCCS/1611/19 - 30-31 October 2019

    Guidance on the safety assessment of nanomaterials in cosmetics

    Link to opinion

    SCCS members: U. Bernauer (Rapporteur and Chairperson of the Working Group), L. Bodin, Q. Chaudhry (SCCS Chair), P. Coenraads (SCCS Vice-Chair), M. Dusinska, E. Gaffet, E. Panteri, V. Rogiers (SCCS Vice-Chair), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCHEER members: W.H. de Jong
    SCCS external experts: A. Simonnard, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1611/19
    Adopted on: 30-31 October 2019


    Background:

    The Guidance is aimed at facilitating the Applicants in preparing safety dossiers, and assisting risk assessors and risk managers in the implementation of the provisions of article 16 of Cosmetics Regulation (EC) No 1223/2009. The Regulation imposes strict conditions and timelines for notification and assessment of cosmetic products containing NMs on the Responsible Persons, as well as on the SCCS. All the essential elements that would be required in an NM safety dossier are covered in this Guidance, i.e. physicochemical characterisation, exposure assessment, toxicological evaluation and risk assessment. As such, this Guidance is complementary to the SCCS general Notes of Guidance for specifically addressing safety aspects of NMs, and therefore must be considered in conjunction with the SCCS Notes of Guidance (SCCS/1602/18 or its most recent revision).

    The Guidance will be revised and updated by the SCCS when considered appropriate to take account of any new scientific advancements and the new knowledge and experience in this field.


    Keywords:

    SCCS, scientific opinion, nanomaterials, Guidance


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Guidance on the Safety Assessment of Nanomaterials in Cosmetics, 30-31 October 2019, SCCS/1611/19.


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  • SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation - 10th revisionAbstract

    SCCS/1602/18 - 24-25 October 2018

    SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation - 10th revision

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry (SCCS Chair), P. Coenraads (SCCS Vice-Chair), M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers (SCCS Vice-Chair and rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    SCCS external experts: A. Koutsodimou, A. Simonnard, W. Uter, N. von Goetz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1602/18
    Adopted on: 24-25 October 2018


    Background:

    The “Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation by the SCCS” is a document compiled by the members of the Scientific Committee on Consumer Safety (SCCS, replacing the former SCCP, SCCNFP and SCC). The document contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of this guidance is on cosmetic ingredients, although some guidance is also indirectly given for the safety assessment of finished products. It is designed to provide guidance to public authorities and to the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation. An important development in recent years was the full implementation of the cosmetic legislation, Regulation (EC) No 1223/2009, meaning that the animal testing and marketing bans fully apply from 2013 onwards: no in vivo testing of finished products after March 2004; no in vivo testing for local toxicity after March 2009 and no in vivo testing for repeated dose toxicity (including sensitisation) toxicokinetics and developmental toxicity from March 2013 onwards for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made with regard to the development and validation of alternative methods, with emphasis on replacement methodology.


    Keywords:

    SCCS, SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 10th revision, SCCS/1602/18


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 10th revision, 24-25 October 2018, SCCS/1602/18.


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  • Checklists for Applicants submitting dossiers on Cosmetic Ingredients to be evaluated by the SCCSAbstract

    SCCS/1588/17 - 7 March 2017 - revised on 16 May 2018

    Checklists for Applicants submitting dossiers on Cosmetic Ingredients to be evaluated by the SCCS

    Link to opinion

    SCCS members: U. Bernauer, Q. Chaudhry (Chairman), P. Coenraads (Vice-Chair), M. Dusinska, V. Rogiers (Vice-Chair), T. Vanhaecke
    External expert: N. von Götz
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1588/17
    Adopted on: 7 March 2017


    Background:

    For timely assessment of the dossiers submitted in support of safety of cosmetics ingredients, it is of utmost importance that they are as complete as possible and contain data that are adequate, relevant, and of suitable quality for use in risk assessment. In this context, this document provides checklists for the parameters that are essential for the SCCS evaluation of cosmetic ingredients, including nanomaterials in cosmetics. The main purpose of these checklists is to enable both the Applicant and the SCCS to quickly assess if the dossiers are complete and to prevent submissions that are incomplete or contain inadequate/irrelevant data. This should streamline the safety evaluation process and save time and resources for both the Applicants and the SCCS.


    Keywords:

    SCCS, Checklists, Applicants, cosmetic ingredients


    Opinion to be cited as:

    Checklists for Applicants Submitting Dossiers on Cosmetic Ingredients, 7 March 2017, SCCS/1588/17.


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  • Memorandum on the use of In Silico Methods for Assessment of Chemical HazardsAbstract

    SCCS/1578/16 - 6 October 2016

    Memorandum on the use of In Silico Methods for Assessment of Chemical Hazards

    Link to opinion

    SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Duus-Johansen, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
    Contact: SANTE-C2-SCCSatec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
    On request from: European Commission
    SCCS Number: SCCS/1578/16
    Adopted on: 6 October 2016


    Background:

    The European Commission’s Independent Scientific Committee on Consumer Safety (SCCS) provides scientific opinions on health and safety risks of non-food consumer products (e.g. cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products) and services (e.g. tattooing, artificial sun tanning).
    Testing cosmetic ingredients and products on animals, and marketing of new cosmetic ingredients/products tested on animals, is now banned in Europe under the EU Cosmetics Regulation (Regulation (EC) No 1223/2009). This has brought the focus on alternative non-animal methods to derive safety data for cosmetic ingredients. The alternative methods include in silico (computational) models and systems that are based on (quantitative) structure-activity relationship, and/or read-across between structurally/functionally similar substances. This Memorandum is intended to provide a general perspective on the current status of in silico methods in risk assessment of cosmetic ingredients in Europe.


    Keywords:

    SCCS, Memorandum, use of In silico Methods, Assessment of Chemical Hazard, Regulation 1223/2009


    Opinion to be cited as:

    SCCS (Scientific Committee on Consumer Safety), Memorandum on the use of In silico Methods for Assessment of Chemical Hazard, 6 October 2016, SCCS/1578/16.


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- Opinions SCCS (April 2013 - March 2016)

Details

Publication date
26 June 2015
Author
Directorate-General for Health and Food Safety