Pharmaceutical & Cosmetic Review February 2020

Page 30

SUN CARE

Regulatory Notification

UV filter EU safety update On 13 December, the EU Scientific Committee for Consumer Safety adopted the ‘Opinion on Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) – Submission II’ by written procedure. Anina van der Walt of Acuservices discusses the outcome as this may have an influence on sun care product development in sunny South Africa.

The use of S87 as a UV filter in cosmetic products is safe up to a maximum concentration of three percent interesting cosmetic product substance and ingredient safety assessment information, which applies to the South African market and may be worth reviewing. Final safety assessments concluded: 1. Alkyl Amide MIPA, of which 14 ingredients were found safe with qualifications 2. Capryloyl Salicylic Acid, one ingredient was tested with an insufficient conclusion

B

for impurities and phototoxicity aspects ased on the data submitted,

ingredients contained in the Cosmetics

the EU Scientific Committee

Regulation (EC) No 1223/2009.

mixture have been concluded safe with qualifications

for Consumer Safety (SCCS) concluded that the use of

3. MCI/MI, two ingredients and one

Opinions nearing finalisation

4. Mannitol, Sorbitol and Xylitol, of which three ingredients have been deemed

Methoxypropylamino Cyclohexenylidene

Other SCCS Opinions on ingredients and

Ethoxyethylcyanoacetate (S87) as a UV

substances, which will be finalised soon

filter in cosmetic products is safe up to a

and worth looking into are:

The following tentative safety assessments

maximum concentration of three percent.

• Dihydroxyacetone – DHA (1,3-Dihydroxy-2-

are in process:

Inhalation toxicity was not assessed in this opinion because no data was provided. As a result, this opinion is not applicable to any sprayable products that could lead to the exposure of consumers’ lungs by inhalation. Are there any further scientific concerns of the SCCS with regard to the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) in cosmetic products? S87 is a secondary amine and

propanone) CAS No. 96-26-4 • the safety of aluminium in cosmetic products – Submission II • SCCS/1613/19 on 30 and 31 October 2019, which is open for comment until 17 February • Zinc Pyrithione (ZPT) submission III; SCCS/1614/19 on 13 December, which is open for comment until 24 February • Hair dye Indigofera tinctoria (C170) CAS

is prone to nitrosation and formation of

84775-63-3 submission III; SCCS/1615/20

nitrosamines. S87 should not be used in

on 10 January, which is open for

combination with nitrosating substances,

comment until 13 March.

The ingredient safety information was

Interesting info worth noting Following the Cosmetic Ingredient Review

adopted and updated accordingly into

(CIR) 153rd Expert Panel Meeting held

the European Commission database for

on 9 and 10 December, a post meeting

information on cosmetic substances and

announcement was published with

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| FEBRUARY 2020 | P C Review

• honey, with seven ingredients being tested and found safe in a preliminary statement • palm (açaí and juçara), of which eight ingredients have been tested with a split conclusion (safe; or insufficient information for composition), so the assessment will continue • pomegranate, of which 18 ingredients were assessed with expert voting resulting in a split conclusion (safe; or insufficient for various endpoints) • soy, of which 28 ingredients were assessed with expert voting resulting in a split conclusion (safe; or insufficient for

and the nitrosamine content should always be < 50 ppb.

safe for use.

various endpoints) • vanilla, of which nine ingredients were tested with voting resulting in a split conclusion (safe; or insufficient for various endpoints). •


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