REGULATORY 13/02/14 - Ot-Public consultation on fragrance allergens

Regulation (EC) No. 1223/2009 on cosmetic products provides that perfume, aromatic compositions and their raw materials shall be referred to, in the list of ingredients on the packaging, as 'parfum' or 'aroma'. However, 26 fragrance allergens listed in Annex III of the Cosmetics Regulation shall be mentioned in the list of ingredients in addition to the term 'parfum' or 'aroma', if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. Moreover, Annex II lists substances which are prohibited in cosmetics, including some fragrance allergens.

In June 2012, Scientific Committee on Consumer Safety (SCCS) adopted a new opinion on fragrance allergens in cosmetic products (SCCS/1459/11).

They updated the list of fragrance allergens that the consumer should be made aware of when they are present in cosmetic products, while confirming that the 26 fragrance allergens currently regulated for individual labelling are still of concern.

Among fragrance allergens established in humans, SCCS identified 12 chemicals and 8 natural extracts of special concern as each of them gave rise to at least 100 reported cases of contact sensitisation.

Finally, SCCS indicated that three fragrance allergens (HICC, atranol and chloroatranol) should not be used in cosmetics. 

So, following the SCCS opinion, there are several areas in which further scientific work is needed, in particular the refinement of the dermal sensitisation Quantitative Risk Assessment (QRA), for which work is ongoing.

In addition, in the areas where SCCS opinion already provides sufficient basis, EU Commission propose to amend Annex III and Annex II of Cosmetics Regulation in order to ensure adequate consumer information and to protect the consumer against the strongest allergens.   

All interested parts, including authorities of the Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumers associations, are invited to submit their comments on the proposed measures and on their possible economic impact by 14th May 2014 at the latest.

REGULATORY 13/12/13 - O-Opinion on Disperse Red 17 COLIPA n° B5

Disperse Red 17 (CAS n. 3179-89-3), COLIPA n°B5, with the chemical name 1-(4'-Nitrophenylazo)-2-methyl-4-bis-(ß-hydiOxyethyl)aminobenzene, is used as a direct dye in oxidative and non-oxidative hair dye formulations.

Scientific Committee on Consumer Products SCCP adopted the opinion SCCP/1161/08. They concluded that the safety of Disperse Red 17 cannot be assessed based on the data submitted.

Submission IV for Disperse Red 17 was submitted by Cosmetics Europe in 2013. According to the applicant, it provides the toxicological study as well as information related to the chemical composition and stability of disperse Red 17.

In the concerned opinion, SCCS concluded that the use of Disperse Red 17 as an ingredient at 0.2% (inclusive of dispersant) in non-oxidative hair dye formulations, and at 2% (inclusive of dispersant) in oxidative hair dye formulations, is safe for the use by consumers.

Disperse Red 17 contains impurities which are prone to nitrosation and may generate nitrosamines. Nitrosamine content in Disperse 17 is not known but the dye should not be used in combination with nitrosating agents.

So, nitrosamine content in Disperse Red 17 should be < 50ppb, and it should not be used in the presence of nitrosating agents.

A skin painting study is available but no information concerning the possible carcinogenic potential of Disperse Red 17 in humans can be obtained.

REGULATORY 13/12/13 - O-Opinion on Methylisothiazolinone (Sensitisation only)

Methylisothiazolinone (MI) is listed in Annex V/57 of Cosmetic Regulation 1223/2009/ECC to be used as preservative at maximum concentration of 0.01% (100 ppm), and in Annex V/39 in the mixture of Methylchloroisothiazolinone (MCI) and Methylisothiazolinone (MI), currently allowed as a preservative in all cosmetics at a maximum concentration of 0.0015 % (15ppm) of a mixture in the ratio 3:1 of the two substances. 

Several Member States raised concern on the use of Methylisothiazolinone as data demonstrates that it is a sensitizer in animals and a contact allergen in human, particularly with sensitization in young children from moist toilet paper/hygiene moist tissues or cosmetics.

EU Commission requested a reassessment of the safety of MI when used as preservative in cosmetics at maximum concentration of 100 ppm.

Current clinical data indicate that this concentration of MI in cosmetic products is not safe for the consumer.

SCCS concluded that for leave-on cosmetics (including ‘wet wipes’), there is no adequate information to suggest a safe dose of MI from the view of induction of contact allergy. 

For rinse-off cosmetics, it may be considered that circa 3.8 ppm MI (as in the MCI/MI mixture) is acceptable as this is the amount present when MCI/MI (3:1) is used at 15ppm for preservation of rinse-off cosmetic products, but it is unknown whether this concentration provides useful preservative activity.

However, as MCI is a more potent allergen than MI and is the principal moiety in MCI/MI, SCCS suggests that MI should be safe in rinse-off cosmetic products at 15 ppm (0.0015%). Permitted levels of MI in rinse-off cosmetics should be safe for previously sensitised individuals but whose allergy has not been shown by formal investigation. 

  

Moreover, MI should not be used as an addition to a cosmetic product already containing MCI/MI.

More frequent review of data to monitor sensitisation frequencies of MI and related isothiazolinone preservatives is recommended.

Labelling is only helpful to a consumer who has a known (established by diagnostic patch test investigations) allergy. It is unknown what proportion of the general population is now sensitized to MI and has not been confirmed as sensitized.

Since MI is widely used in other consumer products (eg. detergents, paints), exposures from such sources should also be assessed.

REGULATORY 13/12/13 - O-Opinion on the safety of boron compounds in cosmetics

Several boron compounds have been classified as CMR 1B substances. They are already covered by entries 1a and 1b in Annex III of Regulation (EC) No 1223/2009.

According to opinion SCCS/1345/10, sodium perborate and perboric acid can be considered as “hydrogen peroxide” releasing substances and thus are covered by entry 12 of Annex III, Regulation (EC) No 1223/2009.

The conditions for exception to the prohibition rule laid down in Article 15, paragraph 2, of Regulation (EC) No 1223/2009 have not been fulfilled.

So, it is necessary to amend entries 1a, 1b and 12 of Annex III of Cosmetics Regulation, in order to indicate that those boron compounds, sodium perborate and perboric acid, classified as CMR 1B, are not allowed anymore for use in cosmetics. 

Furthermore, a clarification on the whole group of borates is needed. Borate are metal salts of boric acid and comprise the following family of chemicals: i.a. potassium borate, zinc borate, sodium tetraborate decahydrate, sodium tetraborate pentahydrate, sodium tetraborate (anhydrous borax), disodium octaborate (anhydrous), disodium octaborate tetrahydrate, and sodium metaborate.

These compounds, on contact with water form boric acid which is classified as CMR 1B.

SCCS is of the opinion that all the substances mentioned above (borates, tetraborates and octaborates) as well as other boric acid salts/esters reported in CosIng database such as MEA-borate, MIPA-borate, potassium borate, trioctyldodecyl borate and zinc borate, break in the product due to contact with water into boric acid.

So, these compounds must be considered to have chemical, biological and toxicological properties similar to boric acid, and general restrictions applicable to boric acid should apply to the whole group of borates.

REGULATORY 13/12/13 - O-Opinion on Bismuth citrate

The chemical Bismuth Citrate (CAS 813-93-4) (EC 212-390-1) is a new substance used in hair dye.

First submission was received by the end of January 2009. It includes a complete dossier and the applicant ask for its safety evaluation when used in progressive hair dye formulation at a concentration up to 2.0% in the finished cosmetic product. 

Progressive hair dyes work gradually, with colour build-up over a period of two to three weeks of daily application. With such application, the hair gradually darkens until the required shade is achieved. Thereafter, colour is maintained by up to 3 applications per week. The product is intended for use by middle-aged and older people, principally men.

According to the current US Code of Federal Regulation, bismuth citrate may be safely used in cosmetics intended for colouring hair on the scalp, subject to the following restrictions:- the amount of bismuth citrate in the cosmetic shall not be in excess of 0.5% (w/v); - the cosmetic may not be used for colouring eyelashes, eyebrows or hair on parts of the body other than the scalp. 

SCCS was asked to evaluate if bismuth citrate, used in hair dye at a maximum concentration of 2.0%, could be safe for consumers, but inadequate information has been provided by the applicant, and therefore SCCS concluded that the safety of bismuth citrate cannot be assessed.     

In fact, the quality of the dossier was poor and contains the following major shortcomings:- Although a concentration of 2% of bismuth citrate in cosmetic formulations is applied for, all of the studies submitted for local toxicity testing were performed with a concentration of 0.5%. In addition, supporting data for the concentration claimed was not provided. - Data on identity and/or characterization of bismuth citrate in batches, lots, and formulations was often missing or inadequate. - Data on solubility and/or stability of bismuth citrate in solvents was missing, partly conflicting or inadequate. - The list of references was poorly sorted, titles of the pdf files were partly misleading and several copies were only partly legible. - The only certificate of analysis (CoA) provided was only partly legible.

In order to proceed with the evaluation of the product safety, a complete and adequate physico-chemical characterisation of Bismuth citrate is needed.

Skin and eye irritation studies are required at the concentration of 2% as applied for by the applicant.

The mutagenicity of bismuth citrate can presently not be assessed given the studies provided. A complete set of in vitro studies according to the current Notes of Guidance is required.