The Dossiers Currently on the Table of the SCCS

A word of caution

The reformulation of cosmetic products is something serious that requires time and money. For this reason, you need to be informed about possible regulatory developments as early as possible…

Just keep in mind that the SCCS is usually very conservative in its assumptions and very stringent in its recommendations. Therefore, their Scientific Opinions usually represent a worst case scenario. It is correct to say that the recommendations made by the SCCS are always taken into consideration by the EU Commission to craft the legislation. However, the SCCS’s Scientific Opinions are rarely transposed as such in the Cosmetics Regulation as the EU Commission has to consider other elements of importance such as the economic impact for the industry and the proportionality of the proposed risk management measure. So, here is the word of caution: do consider these opinions but do not take it as pieces of legislation as this would be wildly speculative. Beyond the reporting of these SCCS Opinions, we will also inform you about the mandates that the EU Commission gave to the SCCS. When the SCCS receives a mandate, this means that the EU Commission poses a question to the SCCS and the SCCS then has to answer this exact question (they are not allowed to change or go beyond the terms of the question). Because the SCCS takes sometimes several years to release an Opinion (when no specific deadline is set by the EU Commission), making assumptions on SCCS Mandates is even more speculative than considering

Part IV

March 14th , 2017

You will find reported below the new mandates and Scientific Opinions published on the SCCS website. It is important to remind that: – The scientific conclusions established by the SCCS in their Opinions cannot be regarded as legal requirements and SCCS Opinions are not pieces of legislation. – However, the Safety Assessors shall1 consider the toxicological data available during the evaluation of a cosmetic product and, in particular, the existing SCCS Opinions. In other words, BIORIUS has to take these scientific conclusions into account and apply most of them in itssafety assessments. Of course, BIORIUS is aware of the complicationsthat thisrepresents and will always show flexibility and understanding to reduce as much as possible the burden caused by new SCCS Opinions.

SCCS Mandates:

NameCASFunctionRegulatedQuestionDates
Aluminium (and all its compounds) (Submission II)Various (CAS of all Aluminium salts)Antiperspirant DeodorantPartly (some salts regulated in Entry 50 of Annex III)Are Aluminium compounds safe in antiperspirants and other cosmetic products such as lipsticks and toothpastes? Propose a limitation if necessary.Submitted: 03/2017 Deadline: 10/2017
HEMA Di-HEMA Trimethylhexyl Dicarbamate868-77-9 41137-60-4 / 72869-86-4Film formingNoIs HEMA safe at up to 35% and Di-HEMA Trimethylhexyl Dicarbamate safe at up to 99% when used in UV-cured artificial nail modelling systems?Submitted: 03/2017 Deadline: 10/2017
QRA 2 */Risk assessment model for fragrance ingredients/Does the SCCS consider QRA 2 adequate to establish a concentration at which induction of sensitization by a fragrance ingredient unlikely to occur?Submitted: 03/2017 Deadline: 10/2017

*This mandate relates to the regulation of 11 fragrance ingredients via a risk assessment model developed by IFRA and partly implemented in the IFRA Standards. More information about this regulatory development.

SCCS Opinions:

NameCASFunctionRegulatedOpinionDates
Dimethylpiperazinium Aminopyrazolopyridine HCl (A164)1256553-33-9Hair dyeNoOn the basis of data provided, the SCCS considers A164 safe when used in oxidative hair coloring products up to a maximum on-head concentration of 2%.Draft: 03/2017 Deadline for comments: 05/2017
Titanium Dioxide (nano form) as UV-Filter in sprays13463-67-7 1317-70-0 1317-4 80-2UV filterYes (VI, 27a) Max. 25 % but prohibited in spraysOn the basis of the provided data, the SCCS has concluded that the information is insufficient to allow assessment of the safety of the use of nano-TiO2 in sprayable application. The use of TiO2 as UV filter in sprays has to remain prohibited.Draft: 03/2017 Deadline for comments: 05/2017
Basic Blue 99 (C059)68123-13-7Hair dyeNoThe 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.Draft: 03/2017 Deadline for comments: 05/2017
Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87)1419401-88-9UV filterNoThe SCCS cannot conclude on the safety of S87. More evidence is needed to exclude the genotoxicity concern regarding S87.Draft: 03/2017 Deadline for comments: 05/2017
Water-soluble zinc salts used in oral hygiene products557-34-6 7646-85-7 4468-02-4 546-46-3 7733-02-0AntimicrobialEntry 24 of Annex III (Max. 1% in all cosmetic products)The SCCS estimates that water-soluble zinc salts via toothpaste is safe for adults and children aged 0.5-17 years. The SCCS estimates that water-soluble zinc salts via mouthwash at the concentrations of 0.1 is safe for adults and children aged 7-17 years.Draft: 03/2017 Deadline for comments: 05/2017

Any questions?

Part III

October 19th, 2016

You will find below the new mandates and Scientific Opinions published on the SCCS website.

SCCS Mandates:

NameCASFunctionRegulatedQuestionDates
Polyaminopropyl Biguanide (PHMB) (Submission II)32289-58-0 27083-27-8 28757-47-3 133029-32-0PreservativeYes (0.3 %) (Article XV ban pending)Is 0.1 % safe in all product categories? If not, specify the product categories where 0.1% is safe.Submitted: 10/2016 Deadline: 12/2016
Acetylated Vetiver Oil (Submission III)84082-84-8Fragrance ingredientNoAre the maximum use levels proposed by IFRA safe? (18 different levels ranging from 0% to 0.68% depending on the product category)Submitted: 10/2016 Deadline: 03/2017
Water-soluble zinc salts in oral care products  Yes (III, 24) Max. 1.0 % as zincAre 1% in toothpastes and 0.1% in mouthwashes as zinc safe? If no, is 0.1% in toothpastes and mouthwashes safe?Submitted: 10/2016 Deadline: 03/2017
Dimethylpiperazinium Aminopyrazolopyridine HCl (A164)1256553-33-9Hair dyeNoIs 2% safe when used in oxidative hair coloring products?Submitted: 10/2016 Deadline: 03/2017

SCCS Opinions:

NameCASFunctionRegulatedOpinionDates
Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)68-26-8 11103-57-4 116-31-4Skin conditioningNo0.05 % of retinol equivalent is safe in body lotions. 0.3 % of retinol equivalent is safe in other leave-on and rinse-off products.Finalized: 10/2016
Phenoxyethanol      122-99-6Preservative    Yes (V, 29) Max. 1.0 %Confirmation that 1.0 % is safe.Finalized: 10/2016

Part II

April 18th, 2016

You will find below the new mandates and Scientific Opinions published on the SCCS website.

SCCS Mandates:

NameCASFunctionRegulatedQuestionDates
HC Orange No. 6 (B125)1449653-83- 1Hair dyeNO0.5% safe when used in non-oxidative hair colouring products?Submitted: 04/2016 Deadline: 09/2016

SCCS Scientific Opinions:

NameCASFunctionRegulatedOpinionDates
Tetrabromophenol Blue (C183)4430-25-5Hair dyeNO0.2% safe when used in oxidative and nonoxidative hair colouring products. This ingredient should be renamed Tetrabromo Bromophenol BlueDeadline for comments: June 9, 2016
N,N’-Bis-(2- hydroxyethyl)-2-nitrop-phenylenediamine (B34)   1.0% (on-head) safe when used as an oxidative hair dye.

1.5% (on-head) safe when used as a nonoxidative hair dye.
Deadline for comments: June 9, 2016

Part I

March 14th, 2016

The Dossiers Currently on the Table of the SCCS

In order to make this kind of letters as short and effective as possible, the information is sorted in two tables: the SCCS mandates and the SCCS Opinions:

SCCS Mandates:

NameCASFunctionRegulatedQuestionDates
Hydroxyethoxyphenyl Butanone’ (HEPB)569646-79-3PreservativeNO2% safe in leave-on, rinse-off and oral care products? If not, propose a safe concentration.Submitted: 01/2016 Deadline: 06/2016
Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate, Retinyl Linoleate and Retinal)68-26-8 11103-57-4 116-31-4Skin conditioningNO(a) 0.3% of retinol equivalent safe in hand/face cream, leave-on (other than body lotions) and rinse-off products?
(b) 0.05% of retinol equivalent safe in body lotions?
Submitted: 06/2015 Deadline: /
Vitamin K1 Oxide (Phytonadione Epoxide)25486-55-9AstringentNO*(a) 1% of Vitamin K1 Oxide safe in cosmetic products?
(b) 1% of Vitamin K2, Vitamin K3 or Vitamin K4 safe in cosmetic products?
Unknown
Phenoxyethanol122-99-6PreservativeYES (V, 29) Max. 1%1% safe in cosmetic products considering the new data?Submitted: 04/2014 Deadline: /
Titanium dioxide (nano)13463-67-7 1317-70-0 1317-80-2UV filterYES (VI, 27) Max. 25%5.5% safe as a UV filter in spray products?Submitted: 09/2015 Deadline: /

This table and the table reported below do not include the status of hair dyes. Furthermore, ingredients already in the regulatory pipeline (EU Commission level) are not taken into consideration. Please, contact us if you need information on these ingredients.

SCCS Scientific Opinions:

NameCASFunctionRegulatedOpinionDates
Acceptable trace level of 1,4-Dioxane123-91-1/YES (II, 343)Trace level of 1,4- dioxane should not exceed 10 ppm in cosmetic products.Deadline for comments: March 18, 2016
Phenylene bisdiphenyltriazine55514-22-2UV filterNOThis ingredient is not safe when used at up to 10% as a UV filter.Draft: July 2015 (to be finalized)
Cyclopentasiloxane (D5)541-02-6Antistatic, emollient, humectant, solvent, etc.NOThis ingredient is safe except for use in body lotions, hairstyling products and products leading to exposure by inhalation (aerosols, powders, etc.). The purity of D5 should be higher than 99% (D4 as low as possible).Draft: March 2015 (to be finalized)
Butylphenyl methylpropional (BMHCA)80-54-6Fragrance ingredientYES (III, 83)This ingredient is not safe in cosmetic products. A ban is recommended.Draft: August 2015 (to be finalized)
Hydroxyapatite (nano)1306-06-5Abrasive, bulking, emulsion stabilisingNOThe safety of this ingredient when used up to a concentration of 10% in oral cosmetic products, cannot be decided on the basis of the data submitted by the applicants.Draft: October 2015 (to be finalized)
Cetylpyridinium chloride123-03-5PreservativeNOThis ingredient is safe when used at up to 0.1% in mouthwashes, up to 0.5% in other oral care products, up to 0.2% in skin lotions and creams and up to 2% in antiperspirant deodorants. Spray products not covered.Final: December 2015
o-Phenylphenol, Sodium ophenylphenate, Potassium ophenylphenate90-43-7 132-27-4 13707-65-8 84145- 04-0PreservativeYES (V, 7) Max. 0.2% (as phenol)o-Phenylphenol is not safe at 0.2% when used in leave-on products. However, 0.15% would be safe.Final: December 2015
Dichloromethane75-09-2SolventYES (III, 7) Max. 35%This ingredient is not safe at 35% when used in hair sprays.Final: October 2015
Hydrolyzed wheat proteins94350-06-8 222400-28-4 70084-87-6 100209-50-5Skin conditioningNOThese ingredients are safe provided that the maximum molecular weight of the peptides in hydrolysates is 3.5 kDa.Final: October 2014
Tagetes extracts and oils91722-29-1 91770-75-1Fragrance ingredientNOThe SCCS considers a maximum level of 0.01% Tagetes minuta and T. patula extracts and essential oils in leave-on products (except sunscreen cosmetic products) as safe, provided that the alpha terthienyl (terthiophene) content of the Tagetes extracts and oils does not exceed 0.35%.Final: March 2015