SCCS Opinion Summaries

Silver (micron-sized particulate)

In the light of the new data provided, indicating that micron-sized particulate Silver does not penetrate the skin, the SCCS considers micron-sized particulate Silver [100nm<particle diameter<1 mm] safe when used up to a...

Thiomersal and Phenylmercuric salts

Not safe — not safe as preservatives in eye cosmetic products at currently permitted levels

Basic Brown 16 (C009)

not safe

Basic Blue 99 (C059)

not safe

Butylated Hydroxyanisole (BHA)

Based on the risk assessment, the SCCS considers the use of BHA in leave-on and rinse off cosmetic products up to a concentration of 0.07% as safe.

Tea Tree Oil

safe with restrictions

Prostaglandin analogues: Methylamido-Dihydro-Noralfaprostal (MDN), Isopropyl Cloprostenate (IPCP), Dechloro Dihydroxy Difluoro Ethylcloprostenolamide (DDDE)

not safe

Benzophenone-2 (BP-2) and Benzophenone-5 (BP-5)

BP-2: insufficient data / not safe; BP-5: safe with restrictions

Diethylamino Hydroxybenzoyl Hexyl Benzoate - DHHB

safe with restrictions

Hydroxyapatite (nano)

safe with restrictions

Methyl salicylate (children revision)

Safe with restrictions for children 0-3 years

Salicylic Acid - Children's exposure

not safe (children - aggregate exposure)

Butylparaben - Children's exposure

Safe with restrictions — safe individually but not in combination at 0.14% for children aged 0.5–10 years

HC Red No. 18 (Colipa No. B124)

safe with restrictions

Benzophenone-1

not safe

Ethylhexyl Methoxycinnamate (EHMC)

safe with restrictions

HC Yellow No. 16 (B123)

safe with restrictions

Biphenyl-2-ol and Sodium 2-biphenylolate

Safe with restrictions — safe for dermal use at specified concentrations; not assessed for oral/inhalation routes

Hexyl Salicylate - children 0-3 years

Safe with restrictions for children ≤3 years old

New coating for Titanium Dioxide (nano form)

insufficient data

Citral sensitisation endpoint

Conditionally safe - QRA2 methodology indicates safety at proposed concentrations but methodology needs refinement before firm conclusion

Silver used in cosmetic products

not safe (general cosmetic use); safe in specific products

Triphenyl phosphate

insufficient data

Acetylated Vetiver Oil (AVO) - sprayable

Safe with restrictions in sprayable cosmetic products (with 1% alpha-tocopherol)

aluminium in cosmetic products - Submission IV

safe with restrictions

Titanium dioxide (TiO2)

insufficient data (oral/inhalation); safe for dermal application (existing opinions stand)

Benzophenone-4

safe with restrictions

Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165)

safe

Hexyl Salicylate

Safe with restrictions

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

safe with restrictions

Benzyl salicylate

Safe with restrictions per Table 1 concentration limits

Methyl salicylate - children 0.5-6 years (scientific advice)

Safe with restrictions for children 0.5-3 years and 3-6 years

HC Blue 18 (B122)

safe

Methylparaben

Safe — safe as preservative at current EU-authorised concentrations

Butylparaben

Safe — safe at 0.14% (as acid); separate opinion issued for children's exposure

Silver Zinc Zeolite

Safe with restrictions — safe only in spray deodorant and powder foundation at specified concentration

Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes (nano)

not safe / insufficient data

Hydroxyapatite (nano)

safe with restrictions

Salicylic acid

safe with restrictions

Sodium bromothymol blue (C186)

insufficient data

aluminium in cosmetic products - Submission III

safe with restrictions

Triclocarban and Triclosan (endocrine disrupting properties)

Safe with restrictions — not assessed in combination; safety based on individual prior opinions

alpha-arbutin and beta-arbutin in cosmetic products

safe with restrictions

Genistein and Daidzein

safe with restrictions

4-Methylbenzylidene camphor (4-MBC)

The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity. Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disrup...

vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)

insufficient data / not safe (subsequently prohibited)

Homosalate as a UV-filter

safe with restrictions

Kojic acid

safe with restrictions

Butylated Hydroxytoluene (BHT)

safe with restrictions

Prostaglandins and prostaglandin-analogues used in cosmetic products

not safe - safety concerns noted

HAA299 (nano)

safe with restrictions

Methyl salicylate

Safe with restrictions per Table 1

formaldehyde warning threshold

safe with restrictions - labelling

Acid Yellow 3 (C054)

safe

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

insufficient data

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

insufficient data

Octocrylene

safe with restrictions

Aluminium in cosmetic products (lipstick) - Submission II

safe with restrictions

Benzophenone-3

safe with restrictions

Hydroxyapatite (nano)

insufficient data

Propylparaben

Safe — safe at 0.14%; in mixtures sum of propyl+butyl not to exceed 0.14%

Homosalate

safe with restrictions

Copper (nano) and Colloidal Copper (nano)

insufficient data

Bisphenol A in clothing articles

safe with restrictions

Resorcinol

safe with restrictions

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

not safe (inhalation route)

Methyl-N-methylanthranilate (MNM) - scientific advice

Safe with restrictions

Indigofera tinctoria (C170)

safe

Zinc Pyrithione (ZPT) - Submission III

Safe with restrictions — safe in rinse-off anti-dandruff hair products at 1%; note: subsequently classified CMR 1B and banned

Aluminium in cosmetic products - Submission II

safe with restrictions

Dihydroxyacetone (DHA)

safe

Tetrabromophenol Blue (C183)

safe

Methylimidazoliumpropyl p-phenylenediamine HCl (A166)

safe

Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165)

not safe

Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87)

safe with restrictions

Ethylzingerone HEPB (P98) - Submission II

Safe with restrictions — safe at 0.7% in all assessed product types; eye irritation concern from Submission I resolved

2-Methoxy-methyl-p-phenylenediamine and its sulfate salt (A160) - eyelash addendum

safe

Salicylic acid - Submission I

safe with restrictions

Climbazole (P64) - Addendum

Safe with restrictions — safe as preservative in face cream/hair lotion/foot care at 0.2% and shampoo at 0.5%; not safe in body lotion

Acetylated Vetiver Oil (AVO) - Submission III

Safe with restrictions in leave-on and rinse-off products (with 1% alpha-tocopherol at IFRA concentrations)

1,2,4-trihydroxybenzene (1,2,4-THB) (A33)

not safe

o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate - Addendum

Insufficient data — safety cannot be confirmed for sodium/potassium/MEA salts; prior OPP opinion stands

Colloidal Silver (nano)

insufficient data

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

insufficient data

Phenylene Bis-Diphenyltriazine (S86)

safe with restrictions

Zinc Pyrithione (P81) - Addendum

Safe with restrictions — safe for anti-dandruff use at 2% in rinse-off hair products

HEMA and Di-HEMA Trimethylhexyl Dicarbamate

safe with restrictions

Butylphenyl methylpropional (p-BMHCA) - Submission II

Not safe (aggregate exposure MoS <100); banned in EU cosmetics from March 2022

Climbazole (P64) - Addendum

Safe with restrictions — safe as anti-dandruff at 2% rinse-off and as preservative in face/hair/foot care at 0.2%; not safe in body lotion

Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) - Submission I

insufficient data

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

safe with restrictions

Basic Blue 99 (C059)

insufficient data

Dimethylpiperazinium Aminopyrazolopyridine HCl (A164)

safe

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

insufficient data

Ethylzingerone HEPB (P98) - Submission I

Safe with restrictions — safe at 0.7%; not safe at requested 2%

Polyaminopropyl Biguanide (PHMB) - Submission III

Not safe — not safe at any concentration up to 0.3%; not safe in spray formulations

Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter

safe with restrictions

HC Orange No. 6 (B125)

safe

Preservative EcoG+

Safe with restrictions — safe when used in cosmetic packaging material releasing silver ions

Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)

safe with restrictions

Phenoxyethanol

Safe — safe at 1% in all cosmetic products for all age groups including infants

Tetrabromophenol Blue (C183)

insufficient data

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

safe with restrictions

1,4-Dioxane (trace levels in cosmetic products; ICCR Working Group Report)

SCCS is of the opinion that trace levels of 1,4-dioxane in cosmetic products representing a LCR 10-5 is considered safe for the consumer. Thus, a trace level of 1,4-dioxane in cosmetic products of 10 ppm is safe.

HC Red No. 18 (124)

insufficient data

HC Yellow No. 16 (B123)

safe with restrictions

Hydroxyapatite (nano)

insufficient data

2,6-Dihydroxyethylaminotoluene (A138)

safe

1-Hexyl 4,5-Diamino Pyrazole Sulfate (A163)

safe

2,5,6-Triamino-4-pyrimidinol sulfate (A143)

safe

HC Blue 18 (B122)

safe with restrictions

HC Yellow No. 17 (B121)

safe

HC Red No. 17 (B120)

safe

Methylisothiazolinone (MI) (P94) - Submission III (Sensitisation only)

not safe (leave-on products)

UV filter S86 Phenylene bis-diphenyltriazine

safe with restrictions

o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate

not safe at 0.2% leave-on; safe at restricted levels

Deoxyarbutin Tetrahydropyranyloxy Phenol

insufficient data

Oxidative hair dye substances and hydrogen peroxide for eyelashes (addendum)

safe with restrictions

α-arbutin

safe with restrictions

Tagetes minuta and T. patula extracts and essential oils (phototoxicity)

Safe with restrictions

β-arbutin

safe with restrictions

Decamethylcyclopentasiloxane (D5) in cosmetic products

safe with restrictions

Cetylpyridinium chloride (P97) - Submission II

safe with restrictions

Dichloromethane - Submission IV

not safe (hair sprays)

2,2'-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)(nano form) S79 - Submission III

safe with restrictions

Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form)

insufficient data

Ethyl lauroyl arginate HCl - Addendum

safe with restrictions

Basic Blue 124

safe

Vetiveryl acetate

Not safe / Insufficient data - major genotoxicity concerns

Butylphenyl methylpropional (BMHCA) - Submission I

Not safe at any proposed IFRA concentration limits (MoS=3.6 or MoS=53 with revised limits)

Clarification on sprayable applications for nano Carbon Black, TiO2, ZnO

safe with restrictions - spray clarification

Formaldehyde in nail hardeners

safe with restrictions

Basic Blue 99 (C59)

insufficient data

Acid Orange 7 (C15)

safe

Poly(hexamethylene) biguanide hydrochloride (PHMB)

not safe (most cosmetic uses)

Hydrolysed wheat proteins - Sensitisation only

not safe (sensitisation risk)

2-(4-(2-(4-Diethylamino-2-hydroxy-benzoyl)-benzoyl)- piperazine-1-carbonyl)-phenyl)- (4-diethylamino-2- hydroxyphenyl)-methanone (HAA299)

safe with restrictions

Basic Brown 17 (B007)

safe

Hydroxyethoxy aminopyrazolopyridine HCl (A161)

safe

3-amino-2,6-dimethylphenol (A162)

safe

Trimethylbenzoyl diphenylphosphine oxide (TPO)

safe with restrictions

Potassium hydroxide (KOH) as callosity softener/remover

safe with restrictions

Peanut oil (sensitisation only)

not safe (sensitisation risk)

aluminium in cosmetic products - Submission I

insufficient data (cannot perform risk assessment)

Boron compounds in cosmetic products

not safe (CMR 1B classification)

Disperse Red 17

safe with restrictions

Methylisothiazolinone (P94) - Submission II (Sensitisation only)

not safe (leave-on)

Thioglycolic acid and its salts (TGA)

safe with restrictions

Ethyl lauroyl arginate HCl (P95) - Submission IV

safe with restrictions

Zinc oxide (nano form) (S76)

safe with restrictions

Titanium Dioxide (nano form)

safe with restrictions

Carbon Black (nano-form)

safe with restrictions

Parabens - propyl- and butylparaben (P82)

safe with restrictions

3-Benzilydene camphor (S61)

not safe (endocrine disrupting)

Zn Pyrithione (P81)

safe with restrictions

Lawsonia inermis (Henna) (C169)

safe

2-Chloro-p-phenylenediamine (A8)

not safe

Diethylene glycol monoethyl ether (DEGEE)

safe with restrictions

Climbazole (P64)

safe with restrictions

Hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate (C117)

safe

HC Blue No. 15

The SCCS is of the opinion that the use of HC Blue n° 15 in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 0.2% does not pose a risk to the health of the consumer.

The SCCS Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation, 8th Revision

Safe — safe for use as solvent/co-solvent in cosmetics (refer to SCCS/1507/13 for revised full opinion)

Climbazole (P64) - Addendum

Safe with restrictions — addendum confirming safety in face/hair/foot care at 0.2% and shampoo at 0.5% preservative; 2% anti-dandruff

Bismuth citrate

insufficient data

Acid Green 25

Scientific opinion (not a safety conclusion) — addressed cross-resistance to medical azoles; no new safety limits set

HC Blue 17 (C184)

safe

HC Blue 15 (C182)

safe with restrictions

Acid Green 25 (C178)

safe

Acid Violet 43 (C63)

safe

Acid Black 1 (B15)

not safe

2-Methoxy-methyl-p-phenylenediamine and its sulfate salt (A160)

safe

2,6-Diaminopyridine (A136)

insufficient data

Zinc oxide (nano-form)

safe with restrictions

Picramic acid and sodium picramate

not safe (hair sprays at 35%)

NDELA in Cosmetic Products and Nitrosamines in Balloons

insufficient data

4-amino-2-nitrodiphenylamine-2'-carboxylic acid (B87)

insufficient data

2,2'-Methylenebis-4-aminophenol HCl (A155)

safe with restrictions

Methylene glycol

safe with restrictions

Benzisothiazolinone

insufficient data

Kojic Acid

safe with restrictions

HC Blue 16 (B119)

safe with restrictions

Toluene-2,5-diamine and its sulfate

safe with restrictions

HC Blue 16

safe

2-Nitro-5-glyceryl methylaniline

safe with restrictions

2-Nitro-5-glyceryl methylaniline (B60)

safe with restrictions

Oxidative hair dye substances and hydrogen peroxide used in products to colour eyelashes

safe

HC Red n° 3

not safe

Benzisothiazolinone (P96)

Safe — safe as preservative at 0.01% in cosmetic products

Tetrabromophenol Blue (C183)

not safe

HC Blue 17

not safe

2,3-Diaminodihydroxypyrazolopyrazolone dimethosulfonate

not safe

Toluene-2,5-diamine and its sulfate (A5)

safe with restrictions

Acetaldehyde

not safe

HC Blue n° 15 (C182)

insufficient data

Disperse Blue 377 (C179)

safe

Acid Red 92 (C53)

safe

Soytrimonium chloride

safe

N,N'-bis-(2-Hydroxyethyl)-2-nitro-p-phenylenediamine

safe

2,6-Diaminopyridine (A136)

insufficient data

Soytrimonium chloride (P72)

safe with restrictions

p-Phenylenediamine (A7)

safe with restrictions

Fragrance allergens in cosmetic products (26 allergens review)

Safe with restrictions for 26 listed allergens; HICC NOT SAFE (ban recommended); atranol/chloroatranol NOT SAFE

Nitrosamines and Secondary Amines in Cosmetic Products

not safe (nitrosamine formation risk)

Furfural

Safe at ≤10 ppm in all finished cosmetic products including oral products; does not pose consumer health risk at this level. (Note: source file opinion number may be an error; actual Furfural opinion is SCCS/1461/12)

Methyl-N-methylanthranilate (phototoxicity only)

Safe with restrictions (phototoxicity assessment only)

1-Hydroxyethyl-4,5-diamino pyrazole sulphate (A154)

safe

p-Aminophenol (A16)

safe

1,2,4-Trihydroxybenzene

safe

Basic Yellow 87 (B117)

safe

4-Formyl-1-methylquinolinium-p-toluenesulfonate (A157)

insufficient data

1-Hydroxyethyl-4,5-diamino pyrazole sulfate

Not found

Basic Brown 17

safe

Basic Orange 31

safe

Parabens; propyl- and butylparaben

safe

Basic Red 51 (B116)

safe

Basic Violet 2 (B115)

safe

p-Phenylenediamine

insufficient data

2-Amino-5-ethylphenol HCl

Safe — no scientific basis to specifically ban parabens from products intended for children under 3 years

Ethyl lauroyl arginate HCl (P95) - Addendum

Safe with restrictions — safe in mouthwashes at 0.15%; not established safe in toothpaste

HC Blue n° 15

safe

Indigofera tinctoria

The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information.

4-Amino-2-nitrophenyl-amine-2'-carboxylic acid (B87)

insufficient data

Acid Orange 7 (C15)

safe

Basic Red 51

safe with restrictions

Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) (INCI: 4-Formyl-1-methylquinolinium-p-toluenesulfonate)

Based on the data provided, Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1) does not pose a risk to the health of the consumer when used as an oxidative hair dye (used in the absence or pres...

N-Methyl-2-pyrrolidone

not safe

Chloroacetamide (P27)

Not safe — not safe under current use conditions

Triclosan - Addendum (P32)

Safe with restrictions — safe in specific product types only; not safe in leave-on body products or sprays

Camphor benzalkonium methosulfate S57 (Addendum)

safe with restrictions (addendum revises SCCP/1203/08)

1,3,5-Triazine, 2,4,6-tris[1,1'-biphenyl]-4-yl

safe with restrictions

Acid Red 92

Based on the data provided, the SCCS is of the opinion that the use of Acid Red 92 with a maximum on-head concentration of 2.0% in oxidative and of 0.4% in non-oxidative hair dye formulations does not pose a risk to the ...

Tetrabromophenol Blue

Based on the data provided, the SCCS is of the opinion that the use of Tetrabromophenol Blue with a maximum on-head concentration of 0.2% in non-oxidative hair dye formulations does pose a risk to the health of the consu...

2,6-Dihydroxyethylaminotoluene

insufficient data

Basic Red 76 (C8)

safe

Picramic acid and sodium picramate (B28)

safe with restrictions

Ethyl lauroyl arginate HCl

The SCCS has revised the Margin of Safety calculation for ethyl lauroyl arginate HCl in cosmetics based on a new dermal absorption study and maintains its conclusion that there are no systemic safety concerns at the curr...

N-Methyl-2-pyrrolidone (NMP)

Based on a worst case assessment with a maximum use concentration of 5% NMP in cosmetic products and a dermal absorption of 100%, the Margin of Safety is considered to be too low. ... With the information available at th...

Pigment Red 57

Therefore, the SCCS concludes that Pigment Red 57 does not pose a risk to the health of the consumer, when used as a direct dye in non-oxidative hair dye formulations, at a maximum on-head concentration of 0.4%.

p-Aminophenol

Based on the data provided, the SCCS is of the opinion that the use of p-aminophenol with a maximum on-head concentration of 0.9% in oxidative hair dye formulations does not pose a risk to the health of the consumer, apa...

Dichloromethane

safe with restrictions

HC Yellow n° 2 (B41)

safe

HC Red n° 10 + HC Red n° 11

safe with restrictions

6-Amino-m-cresol (INCI) / 2-Amino-5-methylphenol

Therefore, the SCCS considers that 2-amino-5-methylphenol is not safe for consumers, when used in oxidative hair dye formulations with a concentration on the scalp of maximum 1.5% taking into account the scientific data ...

Disperse Blue 377

Based on the data provided, the SCCS is of the opinion that the use of Disperse Blue 377 as a non-oxidative hair dye with a maximum on-head concentration of 2.0% does not pose a risk to the health of the consumer. A sens...

Dihydroxyacetone

safe with restrictions

HC Red n° 16 (B114)

safe

Basic Orange 31 (B118)

insufficient data

HC Yellow n° 13 (B102)

safe

HC Red n° 3 (B50)

insufficient data

HC Red n° 13 (B31)

safe

Trisodium nitrilotriacetate (NTA)

insufficient data / concerns raised

1,5-Naphthalenediol (A18)

safe

Pigment Red 57 (hair dye C181)

safe

2,4-Diaminophenoxyethanol dihydrochloride and sulfate (A42)

safe

4-Nitrophenyl aminoethylurea (B70)

safe

Sodium perborate and perboric acid

not safe (CMR 1B classification)

Triclosan Antimicrobial Resistance

Scientific advice — preliminary opinion on antimicrobial resistance risk; not a standard safety conclusion

Polysilicone-15 (S74)

safe with restrictions

Boron compounds

safe with restrictions (pre-CMR classification)

Cyclomethicone D4 and D5

safe with restrictions (2010 assessment)

Disperse Violet 1 (C64)

not safe

Disperse Blue 377

safe

o-Aminophenol (A14)

safe

CI 45430 (Erythrosine)

safe with restrictions

Disperse Black 9 (C106)

not safe

Basic Yellow 57 (C10)

safe

N,N'-bis-(2-Hydroxyethyl)-2-nitro-p-phenylenediamine (B34)

not safe

Vitamin K1 (Phytonadione)

safe with restrictions

Melatonin

not safe (pharmacological activity)

4-Chlororesorcinol (A12)

safe

Toluene-2,5-diamine and its sulfate

safe with restrictions

Alkyl (C16, C18, C22) Trimethylammonium Chloride (P72)

Insufficient data — safety for non-preservative uses cannot be confirmed; additional data required

Hydroxyethyl-3,4-methylenedioxyaniline HCl (A98)

safe

Hydroxyethyl-2-nitro-p-toluidine

safe with restrictions

Basic Red 76

safe

HC Red n° 7 (B36)

safe

HC Blue n° 14

safe

Acid Orange 7

safe

Citric acid and silver citrate

Insufficient data — revised opinion; genotoxicity data gap remains; safety cannot be confirmed (revised from SCCP/1204/08)

4-Nitrophenyl aminoethylurea

Based on the data provided, the SCCS is of the opinion that the use of 4-nitrophenyl aminoethylurea with a maximum on-head concentration of 0.25% in oxidative and 0.5% in non-oxidative hair dye formulations does not pose...

HC Red n° 13 (COLIPA n° B31)

HC Red n° 13 is a moderate skin sensitiser. Based on the data provided, the SCCS is of the opinion that the use of HC Red n° 13 with a maximum on-head concentration of 1.25% in oxidative and 2.5% in non-oxidative hair dy...

2,4-Diaminophenoxyethanol dihydrochloride and sulfate

The SCCS is of the opinion that the use of 2,4-diaminophenoxyethanol dihydrochloride or 2,4-diaminophenoxyethanol sulfate in an oxidative hair dye formulation at a maximum final concentration of 2.0% (after mixing with h...

2,7-Naphthalenediol

The SCCP is of the opinion that 2,7-Naphthalenediol as an ingredient in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1% does not pose a risk to the health of the consumer, apart...

1,5-Naphthalenediol

The SCCP is of the opinion that 1,5-Naphthalenediol as an ingredient in oxidative and non-oxidative hair dye formulations at a maximum on-head concentration of 1% does not pose a risk to the health of the consumer, apart...

Chloroacetamide (2-Chloroacetamide)

On the basis of the data available, the SCCS comes to the conclusion that 2-chloroacetamide is not safe for consumers when used under the current use conditions of 0.3% in cosmetic products. Human data demonstrate that a...

Parabens (P82)

Insufficient data — methyl/ethyl paraben confirmed safe; insufficient data for propyl/butylparaben at 0.4%

Polysilicone-15

In the present assessment, using a weight of evident approach, the SCCS concludes that the use of Polisilicone-15 at a concentration of 0.1% in pressurized hairsprays does not constitute a risk for the consumer.

Basic Violet 2

Based on the data provided, the SCCS is of the opinion that the use of Basic Violet 2 with a maximum on-head concentration of 1.0% in oxidative and 0.5% in non-oxidative hair dye formulations does not pose a risk to the ...

Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane

The SCCS considers that the safe use of Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane as an UV-filter in cosmetic products in a concentration up to maximum 10.0% cannot be assessed based on the available data...

Basic Red 51

Based on the data provided, the SCCS is of the opinion that the use of Basic Red 51 with a maximum on-head concentration of 1% in non-oxidative hair dye formulations does not pose a risk to the health of the consumer. Fo...

Diethylene glycol monoethyl ether (DEGEE)

Based on the new information submitted, SCCS is of the opinion that: 1. the use of DEGEE as a solvent in cosmetic products in a concentration up to 10% in rinse-off products does not pose a risk to the health of the cons...

Melatonin

The SCCS is of the opinion that the use of melatonin in hair products in a concentration of 0.0033% w/w (33 ug/g) does not pose a risk for the health of the consumer.

Hydroxyethyl-p-phenylenediamine sulfate

The SCCS is of the opinion that the use of hydroxyethyl-p-phenylenediamine sulfate itself as an ingredient in oxidative hair dyes at a maximum concentration on-head of 2% does not pose a risk to the health of the consume...

HC Yellow n° 2 (COLIPA n° B41)

Based on the data provided, the SCCS is of the opinion that the use of HC Yellow n° 2 with a maximum on-head concentration of 0.75% in oxidative and of 1.0% in non-oxidative hair dye formulations does not pose a risk to ...

4-Amino-2-nitrodiphenylamine-2'-carboxylic acid

The SCCS is of the opinion that a conclusion on the gene mutation potential of 4-Amino-2-nitrodiphenylamine-2'-carboxylic acid cannot be drawn without further testing. A sensitising potential of 4-Amino-2-nitrodiphenylam...

HC Yellow n° 9

Based on the information provided, the SCCS is of the opinion that the use of HC Yellow n° 9 as a non-oxidative hair dye ingredient at a maximum concentration on the head of 0.5% does not pose a risk to the health of the...

HC Red n° 3 (COLIPA n° B50)

Based on the data provided, the SCCS is of the opinion that the use of HC Red n° 3 as a non-oxidative hair dye with a maximum on-head concentration of 3.0% does not pose a risk to the health of the consumer, apart from i...

o-Aminophenol

Based on the submitted data, no final conclusion on the safety of o-aminophenol can be drawn.

Cyclomethicone (Octamethylcyclotetrasiloxane D4 and Decamethylcyclopentasiloxane D5)

The SCCS is of the opinion that cyclomethicone (D4, D5) does not pose a risk for human health when used in cosmetic products. Other uses were not considered in this risk assessment.

Picramic acid and sodium picramate (COLIPA n° B28)

Based on the data provided, the SCCS is of the opinion that the use of picramic acid/sodium picramate with a maximum on-head concentration of 0.6% in non-oxidative hair dye formulations does not pose a risk to the health...

MCI/MI mixture (P56)

Safe with restrictions — safe in rinse-off products at 0.0015% (15 ppm); not safe in leave-on products

2-Hydroxyethylamino-5-nitroanisole

safe

Citric acid (and) Silver citrate

On the basis of the data submitted, the use of citric acid (and) silver citrate in cosmetic products, at a concentration up to 0.2%, as a preservative does not pose a risk to the health of the consumer. Oral care product...

Resorcinol

The SCCS is of the opinion that the use of resorcinol as an ingredient in oxidative hair dye formulations with a maximum on-head concentration of 1.25% will not pose a risk to the health of the consumer, apart from its s...

Triclosan (antimicrobial resistance)

Based on the available scientific information, it is not possible to quantify the risk of development of antimicrobial resistance induced by triclosan applications, including its use in cosmetics. However, there are envi...

Boron compounds (boric acid, borates, tetraborates)

The SCCS points out that a threshold can be established for the reproductive toxicity of boron compounds. On this basis boric acid, borates and tetraborates are safe when used under the conditions laid down in entry 1a o...

Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) HCl (COLIPA A121)

Based on the information provided, the SCCP is of the opinion that the use of Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) itself as an oxidative hair dye substance at a maximum concentration on the head of 0.4% ...

Mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one (CMIT/MIT, 3:1; COLIPA P56)

On the basis of the data submitted, the SCCS is of the opinion that the mixture of 5-chloro2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one in a ratio of 3:1 does not pose a risk to the health of the consu...

Disperse Violet 1

Based on the information provided, the SCCS is of the opinion that the use of Disperse Violet 1 in semi-permanent hair dye formulations at a maximum concentration of 0.5% does not pose a risk to the health of the consume...

HC Yellow n 4 (COLIPA B38)

Based on the data provided, the SCCS is of the opinion that the use of HC Yellow n 4 as a non-oxidative hair dye with a maximum concentration on the head of 1.5 % does not pose a risk to the health of the consumer.

N,N'-bis-(2-Hydroxyethyl)-2-nitro-p-phenylenediamine

The SCCS is of the opinion that a conclusion on the gene mutation potential of N,N'-bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine cannot be drawn without further testing.

5-Amino-6-chloro-o-cresol (COLIPA A94)

Because of the low margin of safety for the use in both oxidative and non-oxidative hair dye formulations, the SCCS is of the opinion that the use of 5-amino-6-chloro-o-cresol as a hair dye ingredient up to a final on-he...

4-Chlororesorcinol

Based on the information provided, the SCCS is of the opinion that the use of 4-chlororesorcinol itself as an oxidative hair dye substance at a maximum on-head concentration of 2.5% does not pose a risk to the health of ...

Zinc oxide

The SCCP considers that on basis of the dossier reviewed in 2003 the use of ZnO in its non-nano form (pigment grade, with particle sizes above 100 nm) is considered safe. The concern expressed in the SCCNFP opinion 0693/...

HC Blue n° 12

The SCCP is of the opinion that the use of HC Blue n° 12 as an ingredient in non-oxidative hair dye formulations with a maximum on-head concentration of 1.5% and in oxidative hair dye formulations with a maximum on-head ...

2-Hydroxyethyl picramic acid

The SCCP is of the opinion that the use of 2-Hydroxyethylpicramic acid as an ingredient in non-oxidative hair dye formulations with a maximum on-head concentration of 2.0% and in oxidative hair dye formulations with a ma...

4-Amino-3-nitrophenol

The SCCP is of the opinion that, apart from the risks associated with the use of an extreme sensitiser, the use of 4-amino-3-nitrophenol as an ingredient in oxidative hair dye formulations with a maximum on-head concentr...

2-Methylresorcinol

Based on the information provided, the SCCP is of the opinion that the use of 2-methylresorcinol itself as an ingredient in non-oxidative and oxidative hair dye formulations at a maximum on-head concentration of 1.8% doe...

3-Amino-2,4-dichlorophenol HCl

safe with restrictions - clarification

Climbazole

Insufficient data — in vitro gene mutation assay required before safety can be determined

Camphor benzalkonium methosulfate (S57)

safe with restrictions (later revised by SCCS/1430/11 addendum)

Camphor benzalkonium methosulfate

safe with restrictions

Benzophenone-3 (S38)

safe with restrictions

Diethyleneglycol monoethylether

safe (clarification)

Intermediates and reaction products of oxidative hair dye ingredients

safe with restrictions

Intermediates and reaction products of oxidative hair dye ingredients formed during hair dyeing

safe

Citric acid (and) Silver citrate

On the basis of the data submitted, the safety of citric acid (and) silver citrate cannot be assessed. Before a final conclusion can be reached, an in vitro mammalian gene mutation assay to exclude gene mutation potentia...

Triclosan (P32)

Safe with restrictions — safe in specific product types only; not safe overall or in mouthwash at 0.3%

tetra-Aminopyrimidine sulfate (A53)

safe

2-Methyl-1-naphthol (A156)

insufficient data

Diethyleneglycol monoethylether

safe with restrictions

Vitamin K1 (Phytonadione / Phytomenadione)

insufficient data

2-Methylresorcinol (A44)

safe

3-Amino-2,4-dichlorophenol HCl (A43)

safe

4-Methylbenzylidene camphor (4-MBC)

safe with restrictions

Kojic acid

Based on the information provided, margins of safety of respectively 35 (face and hands), 58 (hands) and 88 (face) have been calculated suggesting that the use of Kojic acid at a maximum concentration of 1.0% in skin car...

Diethylene glycol (DEG)

safe

Disperse Red 17 (B5)

insufficient data

Acid Yellow 1 (B1)

not safe

Basic Brown 17

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out.

2-Amino-4-hydroxyethylaminoanisole sulfate (COLIPA n. A84)

In its opinion SCCP/0958/05 of 28 March 2006, the SCCP requested a 'skin penetration test using 2-amino-4-hydroxyethylamino-anisole sulfate and conforming to current Notes of Guidance for Safety Evaluation'. However, the...

Use of the Threshold of Toxicological Concern (TTC) Approach for Human Safety Assessment of Chemical Substances with focus on Cosmetics and Consumer Products

safe with restrictions

Toluene (use as a solvent in nail cosmetics)

In summary, the SCCP is of the opinion that inclusion of toluene up to 25% is safe from the general toxicological view in nail cosmetics used as intended in adults and children. However, the SCCP would like to point out ...

2,5,6-Triamino-4-pyrimidinol sulfate

safe

Hydroxyethyl-p-phenylenediamine sulfate

safe

Diethylamino hydroxybenzoyl hexyl benzoate (COLIPA S83)

insufficient data

Basic Orange 69

safe

HC Orange n° 1

safe

2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene)

insufficient data

2-Nitro-5-glyceryl methylaniline

The SCCP is of the opinion that the safety of 2-nitro-5-glyceryl methylaniline cannot be assessed based on the data submitted. Before any further consideration, an appropriate in vivo test to study the induction of gene ...

Disperse Red 17

The SCCP is of the opinion that the safety of Disperse Red 17 can not be assessed based on the data submitted.

Acid Yellow 1

The SCCP is of the opinion that, apart from the risks associated with the use of a sensitiser, the use of Acid Yellow 1 as an ingredient in oxidative hair dye formulations at a maximum on-head concentration of 1.0% and i...

Choline chloride

The SCCP is of the opinion that the study included in the present submission is not sufficient to answer the concerns about mucous membrane irritation. Before any further consideration, the following information is requi...

alpha-Arbutin

safe

Vitamin K1 (Phytonadione)

safe with restrictions

Diethylene glycol

not safe

Oak moss / Tree moss (sensitisation only)

Conditionally safe at ≤0.1% only if atranol and chloroatranol content reduced to <2 ppm each; not safe at current typical atranol/chloroatranol levels. (Actual opinion number is SCCP/1131/07)

Dermal Sensitisation QRA (Citral, Farnesol and Phenylacetaldehyde)

QRA methodology NOT endorsed - insufficient confidence in model; cannot set definitive safe levels based on this model

4-Methylbenzylidene camphor (4-MBC) (S60)

safe with restrictions (at time of opinion; subsequently banned)

2-Amino-4-hydroxyethylaminoanisole sulfate (A84)

safe

Safety of nanomaterials in cosmetic products

Insufficient data — for propyl/isopropyl/butyl/isobutylparaben; methyl/ethyl remain confirmed safe

Acid Red 52 (C177)

safe

Choline chloride

safe with restrictions

Presence and release of nitrosamines and nitrosatable compounds from rubber balloons

Safe with restrictions — safe at 0.4% as preservative (excluding lips, oral hygiene, sprays); safe at 0.8% in soap/anti-dandruff shampoos/deodorants

2,2'-Methylenebis-4-aminophenol HCl

Because of the low margin of safety for the use in both oxidative and non-oxidative hair dye formulations the SCCP is of the opinion that 2,2'-methylenebis-4-aminophenol HCl as a hair dye ingredient up to a final on-head...

2-Amino-3-hydroxypyridine (A132)

safe

HC Red n° 10 + HC Red n° 11 (B71)

safe

6-Methoxy-2-methylamino-3-aminopyridine HCl (A130)

safe

Vitamin K1 phytonadione

safe with restrictions

HC Blue n° 12

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, the equivocal result obtained with the in vivo Comet assay h...

HC Red n 10 + HC Red n 11 (COLIPA B71)

Consequently, the SCCP is not in a position to perform a risk assessment of HC Red n 10 + HC Red n 11 because of the absence of a proper chemical characterisation of the test substance.

Diethylamino hydroxybenzoyl hexyl benzoate (S83)

safe

Presence and Release of Nitrosamines and Nitrosatable Compounds from Rubber Balloons

safe with restrictions

Oak moss / Tree moss (sensitisation only)

Until such studies are available, it is not possible to estimate if oakmoss, containing atranol and chloroatranol to 2 ppm each, when present up to 0.1% in finished cosmetic products is safe for the consumer. ... untreat...

Polidocanol (Laureth-9)

safe with restrictions

Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products

not safe at high concentrations

2-Amino-3-hydroxypyridine (COLIPA A132)

The SCCP is of the opinion that the use of 2-amino-3-hydroxypyridine in oxidative hair dye formulations at a maximum concentration of 1.0% on the head does not pose a risk to the health of the consumer.

Hydroxyethyl-p-phenylenediamine sulfate

Based on the information provided, a margin of safety of 74 has been calculated suggesting that the use of hydroxyethyl-p-phenylenediamine sulphate as an oxidative hair dye at a maximum concentration of 1.5% in the finis...

1-Naphthol (COLIPA A17)

The SCCP is of the opinion that, apart from the risks associated with the use of a strong sensitiser, the use of 1-naphthol itself in oxidative hair dye formulations at a maximum concentration of 2.0% on the head, does n...

2,5,6-Triamino-4-pyrimidinol sulfate

The SCCP is of the opinion that the safe use of 2,5,6-triamino-4-pyrimidinol sulfate as an ingredient in oxidative hair dye formulations at a maximum concentration of 0.5% on the head cannot be assessed.

6-Methoxy-2-methylamino-3-aminopyridine HCl (COLIPA A130)

The SCCP is of the opinion that, apart from the risks associated with the use of a moderate sensitiser, the use of 6-methoxy-2-methylamino-3-aminopyridine (free base or dihydrochloride) as an ingredient in any hair dye f...

5-Amino-4-chloro-o-cresol HCl

safe

tetra-Aminopyrimidine sulfate

The SCCP is of the opinion that the use of tetraaminopyrimidine sulfate as an ingredient in oxidative and non-oxidative hair dye formulations with a maximum on-head concentration of 3.4% (2.0% free base) does not pose a ...

Resorcinol (A11)

safe with restrictions

Basic Orange 69

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out.

Acid Red 52 (COLIPA n. C177)

The SCCP is of the opinion that the use of Acid Red 52 as an ingredient in oxidative hair dye formulations, at a maximum concentration of 1.5% on the head or in non-oxidative hair dye formulations at a maximum concentrat...

2-Chloro-6-ethylamino-4-nitrophenol (B89)

safe

4-Hydroxypropylamino-3-nitrophenol (B100)

safe

Acid Red 33 (C22)

safe

5-Amino-4-chloro-o-cresol HCl (A117)

insufficient data

HC Blue n° 12 (B73)

insufficient data

Ethyl lauroyl arginate HCl (COLIPA P95)

The SCCP considers, with the additional data provided, that Ethyl Lauroyl Arginate HCl is safe for the consumers, when used: - up to a maximum authorised concentration of 0.4 % as a preservative in cosmetic products, but...

Vitamin K1 (phytonadione)

Because of the inadequate nature of the dossier submitted, the SCCP is unable to provide an adequate safety evaluation for the use of vitamin K1 (phytonadione) and its "oxide" in cosmetic products. However, as such use m...

Hair Dye Sensitivity - Consumer Self Testing

safe with restrictions

HC Orange n° 2

The SCCP is of the opinion that, apart from the risks associated with the use of a strong sensitiser, the use of HC Orange n° 2, at a maximum concentration of 1.0% on the head, does not pose any other risk to the health ...

Acid Red 33

The SCCP is of the opinion that the use of Acid Red 33, at a maximum concentration of 0.5% in non-oxidative hair dye formulations, does not pose a risk to the health of the consumer.

2-Hydroxyethylamino-5-nitroanisole

Since 2-hydroxyethylamino-5-nitroanisole was positive in a gene mutation tests in bacteria, a proper genotoxicity tests covering in vivo gene mutations is essential to definitively conclude on the genotoxicity of 2-hydro...

1,3-bis-(2,4-Diaminophenoxy)propane

The SCCP is of the opinion that the use of 1,3-bis-(2,4-Diaminophenoxy)propane, and its tetrahydrochloride, itself as an oxidative and non-oxidative hair dye at a maximum concentration of 1.8 % (calculated as tetrahydroc...

2-Hydroxyethylamino-5-nitroanisole (B52)

safe

2-Chloro-6-ethylamino-4-nitrophenol

The SCCP is of the opinion that the use of 2-chloro-6-ethylamino-4-nitrophenol, at a maximum on-head concentration of 1.5% in oxidative hair dye formulations and at a maximum on-head concentration of 3.0% in non-oxidativ...

3-Methylamino-4-nitrophenoxyethanol

safe with restrictions

Homosalate

safe

Toluene-2,5-diamine

The SCCP is of the opinion that the use of toluene-2,5-diamine cannot be considered safe based on the available data. This conclusion may be re-evaluated if human toxicokinetic data were to become available in which dosa...

4-Hydroxypropylamino-3-nitrophenol

safe

HC Violet n° 2

safe

HC Yellow n° 10 (COLIPA n° B81)

The SCCP is of the opinion that the use of HC Yellow n°10 itself as a semi-permanent hair dye at an on-head concentration of maximum 0.1% does not pose a risk to the health of the consumer.

HC Blue n° 11

Provided that the nitrosamine content is < 50 ppb, the SCCP is of the opinion that the use of HC Blue n°11 as a non-oxidative hair dye at a maximum concentration of 2.0% on the head does not pose a risk to the health of ...

1,3-bis-(2,4-Diaminophenoxy)propane (A79)

safe

HC Red n° 13

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out.

3-Amino-2,4-dichlorophenol HCl

The SCCP is of the opinion that the use of 3-amino-2,4-dichlorophenol HCl itself as an oxidative hair dye at a maximum concentration of 1.5% in the finished cosmetic product (after mixing with hydrogen peroxide) does not...

4-Nitrophenyl aminoethylurea (B70)

safe

HC Red n° 13 (B31)

safe

2-Hydroxyethyl picramic acid (B72)

insufficient data

HC Yellow n° 10 (B81)

safe

4-Amino-3-nitrophenol (B51)

safe

1,5-Naphthalenediol (hair dye A18)

safe

2,7-Naphthalenediol (A19)

safe

1,5-Naphthalenediol (A18)

safe

Verbena (Lippia citriodora Kunth) conditions of use

Insufficient data - SCCP recognises contradiction between prior opinions; further information required before conclusion can be drawn. Crude verbena oil banned; absolute restricted to ≤0.2%

Alkyl Trimethylammonium Chloride (P72)

Insufficient data — safety for non-preservative uses cannot be confirmed at requested concentrations; additional data required

Fragrance ingredients obtained from Verbena (Lippia citriodora Kunth)

The SCCP recognises contradiction in the entries on 'Verbena (Lippia citriodora Kunth)' in the respective opinions. However, and in order to respond to the questions asked, the following information is required: clarific...

Benzophenone-3

It is the opinion of the SCCP that insufficient data are presented to calculate the Margin of Safety of Benzophenone-3 under the proposed conditions of use. The following additional information is required: - A dermal ab...

Methyl-N-methylanthranilate

Because of the phototoxicity, methyl-N-methylanthranilate should not be deliberately added to leave-on cosmetic products, as there is always the potential for light exposure. Until appropriate toxicity data on the substa...

2,7-Naphthalenediol

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, an in vitro percutaneous absorption study should be performe...

1,5-Naphthalenediol

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, an in vitro percutaneous absorption study should be performe...

4-Amino-3-nitrophenol

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration - an in vitro percutaneous absorption study should be perform...

2-Hydroxyethyl picramic acid (COLIPA n° B72)

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, the possible genotoxic potential must be excluded.

Phenylbenzimidazole Sulfonic Acid and its salts

Based on the information provided, the SCCP is of the opinion that the use of phenylbenzimidazole sulfonic acid and its salts as a UV-filter at a maximum concentration of 8.0% in the cosmetic sun protection preparations ...

Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) HCl

Based on the toxicity of Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) in a subchronic oral rat study (at the lowest systemic dose level of 1.25 mg/kg bw/day derived form toxicokinetic data) and the estimated huma...

Ethylene glycol monobutyl ether (EGBE) / Butoxyethanol

Based on the information provided, the SCCP is of the opinion that the use of ethylene glycol monobutyl ether (EGBE) as a solvent at a concentration up to 4.0% in oxidative hair dye formulations and up to 2.0% in non-oxi...

Diethylene Glycol Monoethyl Ether (DEGEE)

Based on the information provided, the SCCP is of the opinion that the use of diethylene glycol monoethyl ether (DEGEE) in all cosmetic products, except products for oral hygiene and eye products at a concentrations up t...

Diethylene Glycol Monobutyl Ether (DEGBE)

Based on the information provided, the SCCP is of the opinion that the use of diethylene glycol monobutyl ether (DEGBE) as a solvent in hair dye formulations at a concentration up to 9.0% does not pose a risk to the heal...

4-Methylbenzylidene Camphor

The SCCP is of the opinion that presently the safe use of a maximum concentration of 4% 4-MBC in sunscreens cannot be established.

Homosalate (S12)

safe

4-Nitrophenyl aminoethylurea (COLIPA n° B70)

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out. An additional mutagenicity / genotoxicity test should be performed following the relevant SCCN...

3-Nitro-p-hydroxyethylaminophenol

Based on the information provided, the SCCP is of the opinion that the use of 3-nitro-p-hydroxyethylaminophenol itself as an oxidative hair dye substance at a maximum concentration of 3.0% in the finished cosmetic produc...

HC Blue No 2

Based on the information provided, the SCCP is of the opinion that the use of HC Blue n° 2 itself in semi-permanent hair dye formulations at a maximum concentration of 2.8% in the finished cosmetic product does not pose ...

2,6-Dihydroxy-3,4-dimethylpyridine

Based on the information provided, the SCCP is of the opinion that the use of 2,6-Dihydroxy-3,4-dimethylpyridine itself as an oxidative hair dye substance at a maximum concentration of 1.0% in the finished cosmetic produ...

Phenyl Methyl Pyrazolone

Based on the information provided, the SCCP is of the opinion that the use of phenyl methyl pyrazolone itself as an oxidative hair dye substance at a maximum concentration of 0.25% in the finished cosmetic product (after...

Toluene

Although specific information related to the effects in children is limited and because of the low and occasional exposure, the SCCP is of the opinion that the presence of toluene as a solvent in nail cosmetics does not ...

HC Violet n° 1, COLIPA B66

Based on the information provided, the SCCP is of the opinion that the use of HC Violet n° 1 itself as a semipermanent hair dye at a maximum concentration of 0.28 % and as an oxidative hair dye at a maximum concentration...

Parabens

As explained in detail under section 3 of the present opinion, the tests provided in Submission I of February 2006 contain too many shortcomings in order to be considered as scientifically valid. Therefore, the conclusio...

Phthalates in cosmetic products

safe with restrictions (trace impurities) / prohibited (intentional use)

Camphor Benzalkonium Methosulfate

Based on the information provided, the SCCP is of the opinion that the use of camphor benzalkonium methosulphate as a UV-filter at a maximum concentration of 6.0% in the cosmetic sun protection preparations does not pose...

Methyldibromoglutaronitrile (sensitisation only), COLIPA P77

In response to the question asked by the European Commission, the SCCP is of the opinion that no safe use-level for methyldibromo glutaronitrile in cosmetic rinse-off products has been established.

4-Aminobenzoic acid (PABA)

Although 4-aminobenzoic acid is presently permitted and used as a sunscreen, it became apparent in the process of evaluation of the dossier that much of the information did not conform to current standards and guidelines...

Methyl-N-methylanthranilate (phototoxicity only)

Safe with restrictions (rinse-off products only at ≤0.1%); phototoxic in leave-on products

4-Nitro-o-phenylenediamine (B24)

not safe

N-Phenyl-P-Phenylenediamine (A9)

insufficient data

Exposure to reactants and reaction products of oxidative hair dye formulations (doc. n° SCCP/0941/05)

safe

Phenyl Methyl Pyrazolone (A39)

safe

2-Methylresorcinol

safe

4-Amino-2-hydroxytoluene

safe

HC Blue N°2 (B37)

safe

Phenylbenzimidazole sulfonic acid and salts (S45)

safe

Benzophenone-3 (S38)

insufficient data (first submission; data gap)

Camphor benzalkonium methosulfate (S57)

safe

Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester

Although this substance is presently permitted and used as a sunscreen, the SCCP is of the opinion that the information submitted is not conform to current standards and guidelines for the safety evaluation of cosmetic i...

DEGEE Diethylene glycol monoethyl ether

safe with restrictions

N-Phenyl-p-phenylenediamine

safe with restrictions

1-Hydroxyethyl-4,5-diamino pyrazole sulfate, COLIPA A154

The SCCP is of the opinion that the information submitted is inadequate to assess the safe use of the substance.

p-Phenylenediamine

The SCCP is of the opinion that the information submitted is insufficient to allow a final risk assessment to be carried out. Before any further consideration, additional data would be required on in vivo genotoxicity an...

Peru Balsam (Myroxylon pereirae)

The sentence "Peru Balsam ... should not be used as a fragrance ingredient" in opinion SCCNFP/0771/03 of 9 December 2003 relates to the crude exudates only. Opinion SCCNFP/0392/00 of 25 September 2001 clearly proposes th...

Sclareol

The SCCP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required:

Cetylpyridinium chloride

not safe at high concentrations

Vetiveryl acetate (sensitisation only)

The SCCP is of the opinion that the information submitted is inadequate to assess the safe use of the substance.

N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate, COLIPA A50

Based on the information provided, the SCCP is of the opinion that the use of N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate itself as an oxidative hair dye substance at a maximum concentration of 2.5% in the finishe...

HC Red n° 1

The SCCP is of the opinion that the use of HC Red n° 1 in semi-permanent hair dye formulation at a maximum final concentration of 1.0% does not pose a risk to the health of the consumer, apart from its sensitising proper...

4-Nitro-o-phenylenediamine

Based on the information provided, the SCCP is of the opinion that the use of 4-Nitro-o-phenylenediamine itself as an oxidative hair dye substance at a maximum concentration of 0.5% in the finished cosmetic product (afte...

2,4-Diaminophenoxyethanol and its salts

safe

m-Aminophenol

safe

4-Amino-2-hydroxytoluene (A27)

safe

p-Phenylenediamine (A7)

safe with restrictions

4-Methylbenzylidene camphor (4-MBC) (S60)

insufficient data (first submission)

Guidance document on Epidemiological and clinical studies on Tooth Whitening Products

Scientific advice — opinion on triclosan use in non-cosmetic consumer products (guidance document on epidemiological/clinical studies); not a standalone safety conclusion

Parabens (P82)

Insufficient data — conclusion of SCCP/0873/05 remains unchanged: insufficient data for propyl/isopropyl/butyl/isobutylparaben

Hydroxybenzomorpholine, COLIPA A25

Based on the information provided and assuming that the nitrosamine content is less than 50 ppb as required by Directive 76/768/EEC on cosmetic products, the SCCP is of the opinion that the use of hydroxybenzomorpholine ...

Acid Violet 43 (COLIPA C63)

The SCCP is of the opinion that the information submitted is inadequate to assess the safe use of the substance as a hair dye.

p-Methylaminophenol sulphate, COLIPA A22

Based on the information provided, the SCCP is of the opinion that the use of p-methylaminophenol sulphate itself as an oxidative hair dye at a maximum concentration of 0.68% in the finished cosmetic product (after mixin...

1,2,4-Trihydroxybenzene, COLIPA A33

The SCCP is of the opinion that the information submitted is inadequate to assess the safe use of the substance.

2-Amino-4-hydroxyethylamino-anisole sulfate (COLIPA A84)

Based on the information provided, a margin of safety of 65 has been calculated suggesting that 2-amino-4-hydroxyethylamino-anisole and its sulfate is not safe for use as a hair dye and should not be present in hair dyes...

2-Methyl-5-hydroxyethylaminophenol, COLIPA A31

The SCCP is of the opinion that the use of 2-methyl-5-hydroxyethylaminophenol itself as an oxidative hair dye at a maximum concentration of 1.5 % in the finished cosmetic product (after mixing with hydrogen peroxide) doe...

Dihydroxyindole (COLIPA A111)

Based on the information provided, the SCCP is of the opinion that the use of dihydroxyindole itself as a hair dye at a maximum concentration of 0.50% in the finished cosmetic product does not pose a risk to the health o...

Hydroxyethyl-3,4-methylenedioxyaniline HCl (COLIPA A98)

The SCCP is of the opinion that the information submitted is insufficient to assess the safe use of the substance.

Biological effects of ultraviolet radiation relevant to health, with particular reference to sun beds for cosmetic purposes (Preliminary Opinion)

safe

2-Amino-6-chloro-4-nitrophenol

safe

6-Hydroxyindole

Safe with restrictions — safe in rinse-off products at 0.1%; not safe in leave-on products

Lawsonia inermis (Henna) (C169)

safe

Furocoumarins in cosmetic products

Not safe above 1 ppm total furocoumarins in ANY cosmetic product (extended from sunscreens to ALL cosmetics)

1-Hydroxyethyl-4,5-Diamino Pyrazole Sulfate (A154)

safe

HC Violet n° 1 (B66)

safe

4-Aminobenzoic acid (PABA) (S1)

safe

Diethylamino hydroxybenzoyl hexyl benzoate (S83)

safe

Coumarin (sensitisation only)

Contact allergen confirmed even at 99.9% purity; remains on mandatory labelling list; not recommended for de-listing. No new maximum concentration limit set.

Ingredients deriving from category 1-material and category 2-material (animal by-products, Regulation 1774/2002)

the SCCP is of the opinion that ingredients derived from category 1 and 2 material (as defined in Regulation 1774/02) raise concern in terms of biological risk for human health and therefore must not be present in cosmet...

Zinc oxide (microfine/ultrafine) used in sunscreens

Hitherto, the requested safety dossier has not been provided. It is understood that microfine and ultrafine zinc oxide is widely used in sunscreen products on the European market. The safety to the consumer of this use r...

D4 Octamethylcyclotetrasiloxane

safe with restrictions (2005 assessment)

Hydroxyethyl-2-nitro-p-toluidine, COLIPA B75

The SCCP is of the opinion that the information submitted is inadequate to assess the safe use of the substance.

Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1) (COLIPA A157)

The SCCP is of the opinion that the information submitted is insufficient to assess the safe use of the substance.

2-Amino-6-chloro-4-nitrophenol (B99)

safe

Peru Balsam

Crude Peru balsam exudate: banned (confirmed in SCCNFP/0771/03); Peru balsam extracts and distillates: conditionally safe at ≤0.4%

Cetylpyridinium chloride (P97)

Insufficient data — dossier inadequate and non-compliant with standards; new dossier required

Climbazole

Insufficient data - information submitted is inadequate to assess safe use

Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative

Insufficient data - information submitted is inadequate to assess safe use

Acid Violet 43 (C63)

insufficient data

6-Hydroxyindole (A128)

insufficient data

Dihydroxyindole (A111)

insufficient data

p-Methylaminophenol sulphate (A22)

safe

2,4-Diaminophenoxyethanol and its salts (A42)

safe

Hydroxyethyl-3,4-methylenedioxyaniline HCl (A98)

safe

2,6-Dimethoxy-3,5-pyridinediamine HCl

insufficient data

2-Methyl-5-hydroxyethylaminophenol (A31)

safe

1,2,4-Trihydroxybenzene (A33)

insufficient data

CI 26100 (CI Solvent Red 23)

On the basis of provided data the SCCP cannot assess the risk to consumers when CI 26100 is used as a colorant in cosmetic products.

4-Amino-m-cresol

The SCCP is of the opinion that the use of 4-Amino-m-cresol itself as an oxidative hair dye at a maximum concentration of 1.5% in the finished cosmetic product (after mixing with hydrogen peroxide) does not pose a risk t...

Amino Acids obtained by Hydrolysis of Human Hair

It is concluded that the resulting risk, based on current scientific data, of the use in cosmetic products for topical application of amino acids obtained by hydrolysis of human hair or chicken feathers under the conditi...

Octamethylcyclotetrasiloxane (D4) / Cyclomethicone

On the basis of provided data, the SCCP is unable to assess the risk to consumers when Octamethylcyclotetrasiloxane (D4) is used in cosmetic products.

Zinc oxide in sunscreens statement

safe (statement)

Benzoic Acid and Sodium Benzoate

On the basis of provided data, the SCCP is of the opinion that benzoic acid and sodium benzoate are safe for use for preservative and non-preservative purposes in cosmetic rinse-off products at a maximum concentration of...

Alkyl trimethylammonium chloride (P72)

Safe with restrictions — safe for non-preservative uses in hair care and facial creams at specified concentrations

2-Mercaptobenzothiazole (MBT) (sensitisation only)

In response to the questions asked, the SCCP is of the opinion that: The risk of sensitisation from exposure to MBT released from natural rubber soothers and teats is negligible. The CEN standard limit of 8 mg/kg rubber ...

Fluorine safety in oral hygiene (children under 6)

safe with restrictions

Glyoxal

safe

4-Formyl-1-methylquinolinium-p-toluenesulfonate (A157)

insufficient data

Acid Green 25 (COLIPA n C178)

The SCCP is of the opinion that the information submitted is insufficient to assess the safe use of the substance.

Acid Blue 62

safe

Isatin

not safe

Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate (COLIPA n C117)

The SCCP is of the opinion that the information submitted is inadequate to assess the safe use of the substance.

Parabens, underarm cosmetics and breast cancer

safe

the Safety Evaluation of Parabens

safe

Liquidambar spp. Balsam Extracts and Oils (Storax) — Liquidambar Orientalis / Liquidambar styraciflua Balsam Extract and Oil

The provided data do indicate that Storax extracts/oils have allergenic potential, though the quality of the submitted data is poor. However, under the conditions of its anticipated use as a fragrance ingredient (maximum...

Commiphora Erythrea Glabrescens Gum Extract and Oil (Opoponax) (sensitisation only)

Not found

Climbazole (P64)

Insufficient data — comprehensive list of shortcomings in dossier; complete re-evaluation required

Tagetes erecta, T. minuta and T. patula extracts and oils (phototoxicity)

Not safe - should not form part of any cosmetic product (no safe concentration limit demonstrated)

Cresylpropionaldehyde (p-Methyldihydrocinnamaldehyde)

The provided human and animal data demonstrate that Cresylpropionaldehyde (p-Methyldihydrocinnamaldehyde) is a contact allergen. However, under the conditions of its anticipated use as a fragrance ingredient (maximum 0.2...

para-Aminophenol

not safe

Methyldibromo glutaronitrile (MDBGN) (sensitisation only)

In response to the questions asked, the SCCP is of the opinion that: MDBGN was shown to cause elicitation of reactions by repeated open exposures with a rinse-off preparation at the maximum concentration allowed in rinse...

CI Solvent Red 23 (CI 26100)

safe

Acid Blue 62 (C67)

safe

Liquidambar spp. Balsam Extracts and Oils (Storax) (sensitisation)

Conditionally safe at ≤0.6% in consumer products; allergenic potential confirmed but risk of sensitisation is low at intended use level

Commiphora Erythrea Glabrescens Gum Extract and Oil (Opoponax) (sensitisation)

Conditionally safe; only rectified product obtained from crude opoponax by solvent extraction or steam distillation may be used at ≤0.6%

Cresylpropionaldehyde (p-Methyldihydrocinnamaldehyde) (sensitisation)

Conditionally safe - contact allergen confirmed; but risk of sensitisation is low at ≤0.2% in finished cosmetic product

para-Aminophenol (A16)

safe

Isatin (A129)

insufficient data

Bishydroxyethyl Biscetyl Malonamide (Questamide H)

The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance.

Triclocarban (P29)

Safe with restrictions — safe in rinse-off hand/body care products at 1.5% for non-preservative antimicrobial use

Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate (C117)

safe

Mixture of 5-Chloro-2-Methyl-Isothiazolin-3(2H)-one and 2-Methylisothiazolin-3(2H)-one

Safe with restrictions — safe in rinse-off products at 0.1%; not safe in leave-on products

Atranol and chloroatranol in natural extracts (oak moss and tree moss)

Not safe - should not be present at any concentration in cosmetic products; both substances banned

Basic Brown 17 (B7)

safe

Hydrogen Peroxide in Tooth Whitening

safe with restrictions

Tea Tree Oil

safe with restrictions

Hydroxyethyl-p-phenylenediamine Sulfate (A80)

safe

Bishydroxyethyl Biscetyl Malonamide (Questamide H)

safe with restrictions

Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) - sensitisation

Insufficient data for complete assessment; contact allergy is a confirmed problem; up to 0.02% associated with low sensitisation potential but highest safe level not confirmed. Full toxicological data required.

ETHYL LAUROYL ARGINATE

Insufficient data — methyl/ethyl confirmed safe; insufficient data for propyl/isopropyl/butyl/isobutylparaben at 0.4%

Ethyl Lauroyl Arginate (P95)

Insufficient data — mucosal irritation concern; additional data required before safety can be determined

MCI/MI mixture (P56) clarification

Not found — clarification opinion; content not publicly accessible as distinct document

Basic Brown 17 (COLIPA B7)

The SCCP is of the opinion that the information submitted is inadequate to assess the safe use of the substance.

Hydroxyethyl-p-phenylenediamine Sulfate

The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: complete physico-chemical charac...