Monday, April 26, 2021SCCS

Resorcinol, Propylparaben, Benzophenone-3, Octocrylene: Final Opinions of the SCCS

Resorcinol, Propylparaben, Benzophenone-3, Octocrylene : Opinions finales du CSSC

Following the mandate given by the European Commission to the SCCS, in the framework of the evaluation of ingredients listed as endocrine disruptors, the Scientific Committee has just published its final Opinions on the safety of four substances, Resorcinol, Propylparaben, Benzophenone-3, and Octocrylene. They were adopted at the SCCS plenary meeting on 30-31 March 2021.

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Background

Following the publication of a list of 14 suspected endocrine disruptors to be assessed as a matter of priority, and the subsequent call for data, the European Commission asked the SCCS for its Opinion on the safety of Resorcinol, Propylparaben, Benzophenone-3, Octocrylene, and Homosalate.
The Scientific Committee has published its preliminary Opinions on the five substances and has just finalised the first four.

For an exhaustive background information, see the articles
Endocrine disruptors: 5 requests for SCCS Opinions, CosmeticOBS, 10 February 2020
Resorcinol: Preliminary Opinion of the SCCS, CosmeticOBS, 3 November 2020
Propylparaben, Homosalate: Preliminary Opinions of the SCCS, CosmeticOBS, 16 November 2020
Benzophenone-3: preliminary Opinion of the SCCS, CosmeticOBS, 5 January 2021
Octocrylene: preliminary Opinion of the SCCS, CosmeticOBS, 25 January 2021

Resorcinol

Background

Resorcinol is currently regulated as an oxidative hair dye in hair products and products intended for colouring eyelashes in a concentration up to 1,25 % (Annex IV/22 a, b). Furthermore, Resorcinol is also allowed in a concentration up to 0.5 % in hair lotions and shampoos (Annex IV/22 c).
The SCCS preliminary Opinion, published on 16 October 2020, has been subject to a commenting period of eight weeks after its initial publication (from 27 October until 22 December 2020). Comments received during this time period were considered by the SCCS.
The final version has been amended, in particular in the following sections: SCCS comment under section 3.4.5.1 fertility and reproduction toxicity, additional information/SCCS comment/SCCS conclusion under section 3.4.10 special investigations – endocrine activity – in vivo data, as well as related discussion section and references.
The conclusion has not been changed.

The final Opinion

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

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

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

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

Resorcinol is a moderate skin sensitiser based on data from animal studies. Clinical studies show that the frequency of contact sensitisation in humans is low.
The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of resorcinol for the environment.

Propylparaben

Background

Propylparaben is currently regulated as a preservative at a concentration of up to 0.14%, and 0.8% for mixtures of parabens.
The SCCS preliminary Opinion, published on 27-28 October 2020, has been subject to a commenting period of eight weeks (from 6 November until 4 January 2021). Comments received during this time period were considered by the SCCS.
The following section has been slightly revised: physicochemical properties and the related discussion part.
The final conclusions have not been modified.

The final Opinion

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

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

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

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

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

Benzophenone-3

Background

Benzophenone-3 is currently regulated as a UV-filter in sunscreen products in a concentration up to 6 % (Annex VI/4). It is also allowed in a concentration up to 0.5 % to protect product formulation in all other cosmetic products (Annex VI/4).
The SCCS preliminary Opinion, published on 15 December 2020, has been subject to a commenting period of eight weeks after its initial publication (from 15 December 2020 until 15 February 2021). Comments received during this time period were considered by the SCCS.
For this Opinion, some changes occurred, in particular in sections 3.3.2 biomonitoring data, 3.5 safety evaluation section ‘consideration of BP-3 exposure data in humans’ and conclusion number 3.

The final Opinion

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

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

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

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

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

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

Octocrylene

Background

In cosmetic products, Octocrylene (CAS No.6197-30-4, EC No.228-250-8) is currently regulated as a UV-filter in sunscreen products in a concentration up to 10% (as acid) (Annex VI/10).
The SCCS preliminary Opinion, published on 15 January 2021, has been subject to a commenting period of eight weeks after its initial publication (from 18 January until 15 March 2021). Comments received during this time period were considered by the SCCS.
The final version has been amended, in particular in the following sections: chapter 3.1. Physicochemical properties, SCCS comment under chapter 3.4.10.1 and in the discussion on endocrine activity in chapter 3.6, as well as related discussion section and references.
The conclusions remain the same.

The final Opinion

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

On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of Octocrylene (CAS No.6197-30-4), the SCCS considers that it is safe at concentrations of up to 10% when used individually or together as a UV-filter in cosmetic products, i.e. in sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick.
Also, the use of sunscreen propellant spray is considered safe at concentrations of up to 10% when used individually but not safe when used together with face cream, hand cream, and lipstick.

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

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

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

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

Sources
SCCS (Scientific Committee on Consumer Safety), Opinion on Resorcinol (CAS No.108-46-3, EC No.203-585-2), SCCS/1619/20, preliminary version of 16 October 2020, final version of 30-31 March 2021
SCCS (Scientific Committee on Consumer Safety), Opinion on Propylparaben (CAS No.94-13-3, EC No.202-307-7), Preliminary version, SCCS/1623/20, preliminary version of 27-28 October 2020, final version of 30-31 March 2021
SCCS (Scientific Committee on Consumer Safety), Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5), SCCS/1625/20, preliminary version of 15 December 2020, final version of 30-31 March 2021
SCCS (Scientific Committee on Consumer Safety), Opinion on Octocrylene (CAS No 6197-30-4, EC No 228-250-8), SCCS/1627/21, preliminary version of 15 January 2021, final version of 30-31 March 2021

LW
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