Cosmetics & Personal Care | Monthly bulletin | January 2020
Regulatory news - Eurofins updates - Commercial news
Amending and correcting Annex II, III and V of Cosmetics Regulation
On 28th November 2019, the European Commission published the following regulation:
“Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products”.
The main indicated amendments in this regulation are:
- The following entries are added in Annex II to Regulation (EC) No 1223/2009:
|
Reference number |
Substance identification |
||
|
Chemical name/INN |
CAS number |
EC number |
|
|
1612 |
Phosmet (ISO); S-[(1,3-dioxo-1,3-dihydro-2H- isoindol-2-yl)methyl]-O,O-dimethyl phosphorodithioate; O,O-dimethyl-S-phthalimidomethyl phosphorodithioate |
732-11-6 |
211-987-4 |
|
1613 |
Potassium permanganate |
7722-64-7 |
231-760-3 |
|
1614 |
2-Benzyl-2-dimethylamino-4′- morpholinobutyrophenone |
119313-12-1 |
404-360-3 |
|
1615 |
Quizalofop-p-tefuryl (ISO); (+/–) tetrahydrofurfuryl (R)-2-[4-(6- chloroquinoxalin-2- yloxy)phenyloxy]propionate |
200509-41-7 |
414-200-4 |
|
1616 |
Propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4- dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl}-1H- 1,2,4-triazole |
60207-90-1 |
262-104-4 |
|
1617 |
Pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate |
243973-20-8 |
635-361-9 |
|
1618 |
Tetramethrin (ISO); (1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate |
7696-12-0 |
231-711-6 |
|
1619 |
(1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2- methylprop-1-enyl)cyclopropanecarboxylate |
1166-46-7 |
214-619-0 |
|
1620 |
Spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo- 1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate |
148477-71-8 |
604-636-5 |
|
1621 |
Reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy) but-2-ylamine |
897393-42-9 |
447-920-2 |
|
1622 |
1-Vinylimidazole |
1072-63-5 |
214-012-0 |
|
1623 |
Amisulbrom (ISO)3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide |
348635-87-0 |
672-776-4 |
- Entry 98 about Salicylic acid is replaced in the Annex III to Regulation (EC) No 1223/2009
- Entry 3 about Salicylic acid and its salts is replaced in the Annex V to Regulation (EC) No 1223/2009
These amendments shall be applied from 1st May 2020.
The main indicated correction points in this regulation are:
- The entries 395 about Hydroxy-8-quinoline, 1396 about Borates, tetraborates, octaborates and boric acid salts and esters and 1507 about Diaminotoluene are replaced in Annex II to Regulation (EC) No 1223/2009
- The following entries are added in Annex II to Regulation (EC) No 1223/2009:
|
Reference number |
Substance identification |
||
|
Chemical name/INN |
CAS number |
EC number |
|
|
1624 |
Pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate |
23103-98-2 |
245-430-1 |
|
1625 |
1,2-Dichloropropane; propylene dichloride |
78-87-5 |
201-152-2 |
|
1626 |
Phenol, dodecyl-, branched [1] Phenol, 2-dodecyl-, branched [2] Phenol, 3-dodecyl-, branched [3] Phenol, 4-dodecyl-, branched [4] Phenol, (tetrapropenyl) derivatives [5] |
121158-58-5 [1] 1801269-80-6 [2] 1801269-77-1 [3] 210555-94-5 [4] 74499-35-7 [5] |
310-154-3 [1] — [2] — [3] 640-104-9 [4] 616-100-8 [5] |
|
1627 |
Coumatetralyl (ISO); 4- hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl) coumarin |
5836-29-3 |
227-424-0 |
|
1628 |
Difenacoum (ISO); 3-(3- biphenyl-4-yl-1,2,3,4- tetrahydro-1-naphthyl)- 4-hydroxycoumarin |
56073-07-5 |
259-978-4 |
|
1629 |
Brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin |
56073-10-0 |
259-980-5 |
|
1630 |
Flocoumafen (ISO); reaction mass of: cis-4- hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin and trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin |
90035-08-8 |
421-960-0 |
|
1631 |
Acetochlor (ISO); 2- chloro-N-(ethoxymethyl)-N-(2-ethyl-6- methylphenyl)acetamide |
34256-82-1 |
251-899-3 |
|
1632 |
e-Glass microfibres of representative composition |
- |
- |
|
1633 |
Glass microfibres of representative composition |
- |
- |
|
1634 |
Bromadiolone (ISO); 3- [3-(4′-bromobiphenyl- 4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy- 2H-chromen-2-one |
28772-56-7 |
249-205-9 |
|
1635 |
Difethialone (ISO); 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]- 4-hydroxy-2H-1-benzothiopyran-2-one |
104653-34-1 |
600-594-7 |
|
1636 |
Perfluorononan-1-oic acid [1] and its sodium [2] and ammonium [3] salts |
375-95-1 [1] 21049-39-8 [2] 4149-60-4 [3] |
206-801-3 [1] - [2] - [3] |
|
1637 |
Dicyclohexyl phthalate |
84-61-7 |
201-545-9 |
|
1638 |
3,7-Dimethylocta-2,6- dienenitrile |
5146-66-7 |
225-918-0 |
|
1639 |
Bupirimate (ISO); 5-butyl-2-ethylamino-6- methylpyrimidin-4-yl dimethylsulfamate |
41483-43-6 |
255-391-2 |
|
1640 |
Triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1- (1H-imidazol-1-yl)-2- propoxyethanimine |
68694-11-1 |
604-708-8 |
|
1641 |
Tert-Butyl hydroperoxide |
75-91-2 |
200-915-7 |
- Entry 9 regarding Methylphenylenediamines is replaced in Annex III to Regulation (EC) No 1223/2009
- Entry 51 regarding Bis(8-hydroxyquinolinium) sulphate is added in Annex III to Regulation (EC) No 1223/2009
Entry 395 in Annex II and entry 51 in Annex III shall be applied from 11st June 2019.
Please click here to view the full Commission Regulation (EU) 2019/1966 publication.
Recent SCCS publications on Cosmetics
Following recent publications by the Scientific Committee on Consumer Safety (SCCS):
Preliminary opinion on cosmetic ingredients:
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 23 alerts regarding Cosmetic & Personal Care products have been reported, from week 47 until week 50 of 2019.
|
Type of Risk |
Number of alerts |
Notes |
|
Chemical |
23 |
Permanent make-up ink: It contains the aromatic amine o-anisidine and zinc |
|
Tattoo ink: contains the aromatic amines o-anisidine, aromatic amines 4-methyl-m-phenylenediamine, o-toluidine, o-anisidine, an excessive amount of polycyclic aromatic hydrocarbons (PAHs) and benzo[a]pyrene, nickel and barium |
||
|
Eyelash growth product: Tafluprost ethyl amide which should be used under the supervision of an ophthalmologist |
||
|
Brow henna dye: It contains an excessive amount of p-phenylenediamine (PPD), p-aminophenol and m-aminopheno |
||
|
Skin cleansing product: It contains an excessive amount of formic acid |
||
|
Skin lightening product: It contains mercury |
||
|
Hair dye: It contains too much p-aminophenol |
From 21st November to 20th December 2019, CPSC (Consumer Product Safety Commission) has published the following recall: 1 recall regarding Cosmetic & Personal Care products.
|
Type of Risk |
Number of alerts |
Notes |
|
Poisoning risk |
1 |
Essential Oils: The product contains the substance methyl salicylate, which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA) |
Eurofins Cosmetics & Personal Care Canada offers complete nitrosamine testing
As a response to Health Canada's letter dated October 2nd, sent to all Market Authorization Holders (MAHs) requesting to evaluate the risk of the presence of nitrosamine impurities in human pharmaceutical products containing chemically synthesized active pharmaceutical ingredients, Eurofins Cosmetics & Personal Care Canada now offers complete Nitrosamine testing.
Safety assessment of plant extracts: constraints, challenges and solutions by Eurofins Cosmetics & Personal Care
Plant extracts are among the first extracts to have been used in cosmetics, and grow increasingly popular every year. Nowadays, "natural" is synonymous with "safety" in the minds of consumers, but plants can contain substances that are more or less active and potentially dangerous to human health. As with any cosmetic ingredient, their safety for use is cosmetic products must be established and demonstrated through a risk assessment process, in accordance with the requirements of Regulation (EC) No 1223/2009.
Our teams of experts support and advise you in the various stages of plant extract safety assessment: from toxicological profile to physico-chemical analyses, in vitro safety tests, and clinical tolerance assessment.
Eurofins Cosmetics & Personal Care at Cosmet'agora - Paris
Meet our Eurofins team at booth 70 during the upcoming Cosmetagora in Paris, on January 14th and 15th, 2020. Throughout these 2 days our team will present our unique testing offer and our latest capabilities.
Eurofins EVIC France will host a conference on safety assessments specifically aimed to evaluation the exposure of beauticians to professional use cosmetic products on 31st of January
Eurofins EVIC France's safety assessment team will host a conference aimed at manufacturers of professional use cosmetics and on the beauticians' exposure to risks. The conference will be held in Eurofins ATS lab, Aix-en-Provence, on Friday, 31st of January.
The study is based on exchanges with 117 beautician centers in order to assess the most commonly found practices for product application. The results of this survey will provide vital information related to the exposure scenarios of professional use cosmetics used in the safety assessments (carried out by Eurofins EVIC France team).
The conference will be led by Adeline Nalin, senior toxicologist Eurotox certified and the head of our Safety Assessment team, and Charlène Thomas, student in 5th year of pharmacology who carried out the survey. Several customers who took part in this study will attend this conference.
Seminar on Safety and Efficacy Test of Cosmetic and Market Profile, on January, 15th in Hong Kong
In recent years, the demand for cosmetics has been growing at a fast pace, while China has leaped to the world's second largest consumer market. With the rapid development of Guangdong-Hong Kong-Macau Greater Bay Area and different policies adopted by the Hong Kong government, enormous domestic sales opportunities have emerged. At this seminar, experts from Opal International Trading Co., Ltd. and Eurofins will share information on cosmetic testing such as safety and efficacy testing with the case study. Expert from Hong Kong Productivity Council will introducing various supporting schemes offered by government for boosting domestic sales. The seminar will take place on January, 15th in Hong Kong.
Eurofins | CRL will be sponsoring the cocktail hour at NYSCC Event in January
The NYSCC Event, An update on the FDA New Proposed Sunscreen Regulation: The Testing Protocol and the Impact on Industry and the Consumer, will take place in Woodbridge, New Jersey on January 29th, 2020.
During the event there will be speakers from the FDA discussing the new proposed sunscreen regulations and others will discuss how these new regulations may have an impact on the sunscreen industry and it’s consumers.
