Eurofins | June 2019 regulatory Newsflash compilation | Cosmetics & Personal Care
Recent SCCS publications on Cosmetics
Following some recent publications of Scientific Committee on Consumer Safety (SCCS):
Request for a scientific opinion on:
Final opinion on cosmetic ingredients:
- SCCS - Final Opinion on the safety of Butylphenyl methylpropional (p- BMHCA) in cosmetic products - Submission II.
Preliminary opinions open for comments:
- SCCS- Preliminary Opinion open for comments on Allergy Alert Test (AAT) as a proof-of-concept study (deadline for comments: 12 July 2019).
Regulatory updates to Cosmetic Products Regulation
In May, the European Commission published several regulatory amendments and a decision about Cosmetics regulation. Below a summary with these recent publications:
1) Commission Regulation (EU) 2019/698 of 30 April 2019 amending Annexes III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with reference C/2019/3123.
The 310 entry is added in Annex III to Regulation (EC) No 1223/2009:
|
Chemical name/INN |
Name of Common Ingredients Glossary |
CAS number |
EC number |
Product type, body parts |
Maximum concentration in ready for use preparation |
Other |
|
1-(4-Chlorophenoxy)- 1-(imidazol-1-yl)-3,3- dimethylbutan-2-one. (*) |
Climbazole |
38083-17-9 |
253-775-4 |
Rinse-off anti-dandruff shampoo (**) |
2,0 % (**) |
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. (**) |
|
(*) For use as a preservative, see Annex V, entry 32.
(**) From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those restrictions shall not be placed on the Union market.
From 27 February 2020 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those restrictions shall not be made available on the Union market. |
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The entry 32, in Annex V to Regulation (EC) No 1223/2009, is replaced by the following:
|
Chemical name/INN |
Name of Common Ingredients Glossary |
CAS number |
EC number |
Product type, body parts |
Maximum concentration in ready for use preparation |
|
1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one. (*) |
Climbazole |
38083-17-9 |
253-775-4 |
Hair lotions (**) |
0,2 % (**) |
|
Face creams (**) |
0,2 % (**) |
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| Foot care products(**) |
0,2 % (**) |
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|
Rinse-off shampoo (**) |
0,5 % (**) |
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(*) For use other than as a preservative, see Annex III, entry 310. (**) From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be placed on the Union market. From 27 February 2020 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be made available on the Union market. |
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2) Commission Regulation (EU) 2019/681 of 30 April 2019 amending Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with reference C/2019/3121.
The 1384 entry is added to Annex II to Regulation (EC) No 1223/2009:
|
Chemical name/INN |
CAS number |
EC number |
|
2-chlorobenzene-1,4-diamine (2-Chloro-p-Phenylenediamine), its sulfate and dihydrochloride salts when used as a substance in hair dye products, including eyebrow dye products, and eyelash dye products (*). |
615-66-7 61702-44-1 (sulfate) 615-46-3 (dihydrochloride) |
210-441-2 262-915-3 210-427-6 |
|
(*) From 22 November 2019 hair dye products, including eyebrow dye products, and eyelash dye products containing those substances shall not be placed on the Union market. From 22 February 2020 hair dye products, including eyebrow dye products, and eyelash dye products containing those substances shall not be made available on the Union market. |
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3) Commission Regulation (EU) 2019/680 of 30 April 2019 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with reference C/2019/3110.
The 31 entry is added to Annex VI to Regulation (EC) No 1223/2009:
|
Chemical name/INN/XAN |
Name of Common Ingredients Glossary |
CAS number |
EC number |
Maximum concentration in ready for use preparation |
Other |
|
3,3′-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine). |
Phenylene Bis-Diphenyltriazine |
55514-22-2 |
700-823-1 |
5% |
Not to be used in applications that may lead to exposure of the end user's lungs by inhalation. |
4) Commission Decision (EU) 2019/701 of 5 April 2019 establishing a glossary of common ingredient names for use in the labelling of cosmetic products with reference 32019D0701.
5) Commission Regulation (EU) 2019/831 of 22 May 2019 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with reference C/2019/3717. This Regulation entered into force on 12th June, 2019.
Reminder: upcoming dates for some substances
Cosmetic products containing Sodium 2-biphenylate, Potassium 2-biphenylate or 2-aminoethan-1-ol; 2-phenylphenol, which do not comply with Regulation (EU) 2018/1847, shall not be placed on the Union market from 17 June 2019 and they shall not be made available on the Union market from 17 September 2019.
The non-compliance of tooth whitening products
On 2nd May 2019, the European Directorate for the Quality of Medicines & Health Care (EDQM) published the report about the quality of tooth whiteners and whitening strips assessed in a Market Surveillance study. 12 European countries participated in this study, completed in 2018.
EDQM recommends closely monitoring of these products by national competent authorities because the findings of the study indicated that a large number of products were non-compliant with European Union or national regulation for cosmetics products.
Click here for more information from EDQM website.
Two approved non-animal tests for cosmetic ingredients
Nowadays, animal testing on cosmetic ingredients are mandatory in China. But Chinese authorities and cosmetics organisations are working together to remove the mandatory animal testing requirements and to promote the acceptance of alternative methods.
One step was done last March when the China’s National Medical Product Administration (NMPA) published a notification about 9 cosmetics ingredients testing methods that are accepted for use under China’s technical safety standard for cosmetics. Of these 9 tests, 2 are approved non-animal tests:
- Skin sensitisation – direct peptide reactivity assay (DPRA).
- Eye irritation or corrosion – short time exposure in vitro test method (STE).
And the rest of the tests are:
- New test methods:
- Determination of free formaldehyde in cosmetics.
- Local lymph node assay (LLNA): daicel adenosine triphosphate (LLNA-DA).
- Local lymph node assay: 5-bromo-2-deoxyuridine enzyme-linked immunosorbent assay (LLNA-BrdU Elisa).
- Revised test methods:
- Determination of cantharidin and chlormethine in cosmetics.
- Determination of 10 α-hydroxy acid in cosmetics.
- Bacterial reverse mutation assay.
- Teratogenicity test.
From January 1, 2020, these testing methods for cosmetics registration, filing, and supervision and inspection shall be used.
Click here for getting the official publication (in Chinese).
Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”) and in the US (Source “CPSC”).
Europe
RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).
The following 14 alerts regarding cosmetic products have been reported, from week 16 until week 20 of 2019.
|
Type of Risk |
Number of alerts |
Notes |
|
Chemical
|
13
|
Tattoo ink containing allergic and carcinogenic substances as:
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Skin-lightening product containing irritating substances as hydroquinone. |
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Perfume containing allergic and sensitization fragrances as:
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Microbiological |
1 |
Cosmetic product containing an excessive level of aerobic mesophilic bacteria. |
From on 21st April to 20th May 2019, CPSC (Consumer Product Safety Commission) has published the following recalls: 0 recalls regarding cosmetic products.
