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Media Centre >> News >> Cosmetics & Personal Care | Monthly bulletin | January 2020

Cosmetics & Personal Care | Monthly bulletin | January 2020

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Tuesday, January 7, 2020

Eurofins newsflash Cosmetics and Personal Care

Regulatory news - Eurofins updates - Commercial news 

 

Regulatory news


 

Europe

 

 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:

 

 

Product Recalls/Alerts

 

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

 

US

 

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 updates 


Top▲ 

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.

Read more >>

 

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.

Read more >>

 

Commercial news


Top▲

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.

Read more >>

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.

Read more >>

 

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.

Read more >>