Eurofins | Newsflash - December 2018 | Cosmetics

24 & 48 Hour Primary Irritation Panels starting at Eurofins CRL Austin

Are you interested in testing the Primary Irritation potential of your products? If so, Eurofins CRL offer both 24 and 48 hour shared and exclusive panels at our Eurofins CRL Austin location. A primary irritation test is used to determine primary irritation of substances patched on subject's backs after a 24 or 48 hour exposure period. A PI test is completed in a much shorter time frame compared with an RIPT and only shows irritation to the skin, not sensitization. This method is a good screening tool for skin irritation when testing multiple formulations or if you are in the beginning stages of product development. If this is something you or your company may be interested in, feel free to reach out to Cometics-US@eurofins.com

Follicular Biopsy studies are officially back at Eurofins CRL Piscataway

Follicular Biopsy panels are officially back up and running at Eurofins CRL Piscataway. If you are unfamiliar with this type of test, it is a high throughput method used to determine product comedogenicity and supports the claim "non-comedogenic". Every year we take a short break from Follicular Biopsies during the summer months, but we are happy to be offering shared panels once again to our clients during the Fall to Spring months. Please contact us, Cometics-US@eurofins.com, for more information.

Europe

New dates for EU Ecolabel criteria

The European Commission has recently published several decisions about the EU Ecolabel criteria. See following the summary table:

Date	Code	Title	The related assessment and verification requirements, shall be valid until:
23.10.2018	C(2018) 6805	COMMISSION DECISION (EU) 2018/1590 of 19 October 2018 amending Decisions 2012/481/EU, 2014/391/EU, 2014/763/EU and 2014/893/EU as regards the period of validity of the ecological criteria for the award of the EU Ecolabel for certain products, and of the related assessment and verification requirements.	For absorbent hygiene products: 31.12.2022 For rinse-off cosmetic products: 31.12.2021

Europe

Draft regulation amending Cosmetic products Regulation

The following draft regulation has recently been notified to World Trade Organization (WTO) by the European Commission.

Reference	Date	Title
G/TBT/N/EU/613	23/10/2018	Draft Commission Regulation amending Annexes III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. Restricting the use of Climbazole as a preservative in hair lotion (0.2 %), face cream (0.2 %), rinse-off shampoo (0.5 %), foot care products (0.2 %) and as an anti-dandruff agent in rinse-off shampoo up to 2.0 %.

Europe

Report about substances with endocrine-disrupting properties

On 7^th November 2018, the European Commission published the report “Review of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with regard to substances with endocrine-disrupting properties”. Click here for getting the report from European Commission website.

Europe

Recent SCCS Opinions on Cosmetics

Following some recent Opinions of Scientific Committee on Consumer Safety (SCCS): Final Opinion on:

SCCS- Colloidal Silver (nano) - The SCCS adopted this Opinion at its plenary meeting on 24-25 October 2018

Guidance document:

THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 10^TH REVISION. It was adopted in the SCCS’s plenary meeting on 24-25 October 2018. Below the main points:

Structural changes

The general structure has been changed to give priority to non-animal methods, followed by older in vivo strategies
In the Annexes of this guidance the information on Regulation 1223/2009/EC and guidance related to finished cosmetic products (Product Information File, PIF) is included
A revised checklist has been added for submitting a safety dossier to the SCCS
An update of the data needed for safety evaluation and information for re-submitting is also given in case of a negative opinion
Updated references and abbreviations lists
Exposure chapter has been updated (with subdivisions for external and internal exposure – tiered approach and aggregate exposure are discussed.)

Changes in content

Added an update on non-animal toxicological studies for cosmetic ingredients
Weight of Evidence (WoE) and use of a 'toolbox' (genotoxicity/mutagenicity) are discussed
Added an update of criteria for multi-constituent natural ingredients and chemical identity
The new suggested values of Threshold of Toxicological Concern concept (TTC), in publication, have not yet been evaluated
An overview of consumer exposure data has been added in Appendix 7

Request for a scientific opinion on:

SCCS - Ethylzingerone with INCI name ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 - CAS No 569646-79-3 - Submission II – Eye irritation
SCCS - hair dye Tetrabromophenol Blue, 4,4’-(4,5,6,7- tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (CAS 4430-25-5) (C183). Submission IV

Request for an Addendum to:

Scientific opinion SCCS/1491/12 on the hair dye substance 2-Methoxy-methyl-p-phenylenediamine and its sulfate salt (CAS 337906-36-2 and 337906-37-3 respectively) (A160). Submission II – use in eyelashes

Lead Acetate ban in hair dyes

On 30^th October, the U.S. Food and Drug Administration (FDA) published the constituent update indicating that lead acetate will not be able to be used as ingredient in cosmetic products for coloring hair. This rule is effective from 3^rd December 2018 with a transitional period of 12 months for the industry to reformulate products. Click here for getting the official news from FDA website.

Canada

Carcinogenicity potential from 7 colorant ingredients

On 3^rd November, the Government of Canada published a draft screening assessment of seven Anthraquinones substances with carcinogenicity potential. Theses 7 substances are:

Solvent violet 13
Pigment blue 60
Solvent violet 59
Solvent blue 36
Disperse red 60
Acid blue 239
"9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl", including methyl- and pentyl- derivatives

Click here for getting the Draft screening assessment Anthraquinones group.

China

Guangdong Cosmetics Safety Regulation Opens to Public Consultation

On 5^th November 2018, the Standing Committee of Guangdong Provincial People’s Congress released a draft of Guangdong Cosmetics Safety Regulation. The main contents of the draft include cosmetic manufacturing, sales, supervision management and punishment clauses. Public consultation was open until 30^th November 2018. Click here for more information (in Chinese).

International

Crunch Time for Reviewed Sunscreen Standards

The ISO TC 217 Working Group 7 meeting held in Monaco in November 2018 had evolved into what should be a deadline for the finalization of a number of standards, ISO 24443 and ISO 24444 as reviewed standards and then 2 more will appear for the first time – both relative to water resistance testing.

ISO 24444 is the primary and key test method and is the methodology now recognized in over 60 countries. It has now passed through the sixth draft of the revised document and should be in public comment stage following the November 2018 meeting. Based on the final wording of this document, these two water resistance standards will also be ready for publication. As well as these, ISO 24443 is a basic review of the existing Broad Spectrum requirements for Australia, as well as for around 60 other countries. Change to this should be minimal. References:

ISO 24444Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) Working Draft 6.
ISO 16217 Cosmetics - Sun protection test methods - Water resistance - water immersion procedure
ISO 18861 Cosmetics - Sun protection test methods - Determination of percentage of water resistance
ISO 24443 Cosmetics - Sun protection test methods - Determination of sunscreen UVA photoprotection in vitro

Products 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 12 alerts regarding cosmetic products have been reported, from week 43 until week 46.

Type of Risk	Number of alerts	Notes
Chemical	9	2-Aminophenol
		p-Phenylenediamine
		Toluene-2,5-diamine sulphate
		Methylisothiazolinone (MI) and Methylchloroisothiazolinone (MCI).
		Aromatic amine (o-anisidine)
		Aromatic amine (o-toluidine)
		Hydroquinone
Choking	1	Soap: Due to its characteristic appearance, colour and size, the product may be mistaken for a foodstuff. The product has pieces that can be easily detached. A child may put these pieces in the mouth (choking hazard). The product does not comply with the Cosmetics Regulation or with the requirements of the Food imitating Products Directive.
Microbiological	2	Risk of microbiological contamination

From on 21^st October to 20^th November, CPSC (Consumer Product Safety Commission) has published the following recalls: 0 recalls regarding cosmetic products.