SCCS - Opinions 2016 - 2021
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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 period of eight weeks (the exact timeline is given for each Opinion) by the Applicant who submitted the dossier.
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.
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SCCS/1601/18 - 10 September 2018
Open for comments until 14 November 2018Salicylic 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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1601/18
Adopted on: 10 September 2018Conclusion 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 oral products such as toothpaste and mouthwash. Sprayable products that could lead to exposure of the consumer’s lung by inhalation are also excluded.
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, this Opinion is not applicable to oral products such as toothpaste and mouthwash. 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?
The total content of salicylic acid, including when used as preservative at a concentration up to 0.5%, should not exceed 3.0 % for the cosmetic rinse-off hair products and 2.0 % for other products. Salicylic acid is also used as a preservative in food and as a biocide in some consumer products (see section 3.2.3). 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, salicylic acid, Regulation 1223/2009, CAS 69-72-7, EC 200-712-3
Opinion to be cited as:
SCCS (Scientific Committee on Consumer Safety), Opinion on salicylic acid (CAS 69-72-7) - Submission I, preliminary version of 10 September 2018, SCCS/1601/18.
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.
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SCCS/1598/18 - 21-22 June 2018
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. Simonnard, A. Koutsodimou
Contact: SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1598/18
Adopted on: 21-22 June 2018Conclusion 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 data available in open literature, the SCCS considers that 1,2,4-trihydroxybenzene is not safe due to potential genotoxicity when used as an auto-oxidative hair dye in permanent hair dye formulations.
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%?
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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?
No data have been provided to indicate the fate of 1,2,4-trihydroxybenzene in the finally applied mixtures and hence the extent of consumer exposure to 1,2,4-THB and transformation products is not known.
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, 21-22 June 2018, SCCS/1598/18.
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SCCS/1599/18 - 21-22 June 2018
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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1599/18
Adopted on: 21-22 June 2018Conclusion 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) added 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 based on animal studies.
In this Opinion SCCS did not assess aerosolised or sprayable application that could lead to exposure of the consumer’s lung by inhalation.
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, 21-22 June 2018, SCCS/1599/18.
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SCCS/1596/18 - 21-22 February 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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1596/18
Adopted on: 21-22 February 2018Conclusion 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 of 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 nanosilver 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 safety assessment of nano silver, consideration should also be given to the likely presence of ionic silver in different type 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 (nano), 21 February 2018, SCCS/1596/2018.
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SCCS/1591/17 - 14 December 2017
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, L. Celleno, 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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1591/17
Adopted on: 14 December 2017Conclusion 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?
Based on analysis of data provided in submission I and additionally in submission II, the SCCS is of the opinion that genotoxicity potential of BMHCA cannot be excluded. Therefore, the SCCS cannot conclude on the safety of BMHCA.
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 (under REACH) will also need to be taken into consideration for any future assessment of the substance.
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, 14 December 2017, SCCS/1591/2017.
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.
Cosmetic ingredients
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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1594/18
Adopted on: 30 July 2018Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1600/18
Adopted on: 21-22 June 2018Conclusion 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?
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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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1592/17
Adopted on: 21-22 June 2018Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1586/17
Adopted on: 21-22 June 2018Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1593/18
Adopted on: 21-22 February 2018Conclusion 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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1597/18
Adopted on: 21-22 February 2018Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1590/17
Adopted on: 24-25 October 2017Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1587/17
Adopted on: 14 July 2017Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1581/16
Adopted on: 7 April 2017Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1582/16
Adopted on: 7 April 2017Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1577/16
Adopted on: 6 October 2016Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1575/16
Adopted on: 6 October 2016Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1576/16
Adopted on: 6 October 2016Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1549/15
Adopted on: 25 March 2015 - Final version of 29 July 2016Conclusion 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.
Hair dyes
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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1584/17
Adopted on: 7 March 2017Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1585/17
Adopted on: 7 March 2017Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1573/16
Adopted on: 16 March 2016Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1579/16
Adopted on: 7 November 2016Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1572/16
Adopted on: 16 September 2016Conclusion 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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Skin Sensitisation Quantitative Risk Assessment for Fragrance Ingredients (QRA2) - Submission I Abstract
SCCS/1589/17 - 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, L. Celleno, Q. Chaudhry, P. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, T. Vanhaecke, S. Wijnhoven
External experts: N. von Götz, A. Simonnard
Contact: SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1589/17
Adopted on: 30 July 2018Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1595/18
Adopted on: 21-22 June 2018Conclusion 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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1583/17
Adopted on: 19 January 2018Conclusion 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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1580/16
Adopted on: 7 November 2016Conclusion 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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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 Nanomaterials in Cosmetics
- Checklists for Cosmetic ingredients (not for nanomaterials)
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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1588/17
Adopted on: 7 March 2017Background:
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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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-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1578/16
Adopted on: 6 October 2016Background:
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.
- Opinions SCCS (April 2013 - March 2016)
