Cosmetics & Personal Care | Monthly bulletin | February 2020
Regulatory news - Eurofins updates - Commercial news
The United Kingdom has left the European Union
On the 1st February 2020, the United Kingdom left the European Union. At this moment there is a transition period until the end of 2020 while the UK and EU negotiate additional arrangements. The current standards and legislations for the UK and EU will continue to apply during the transition period. New legislations will take effect on the 1st January 2021.
For further general information about Brexit click here to visit the GOV.UK website.
Animal free sunscreen testing
Eurofins participated in the ISO TC 217 working Group which met in Winterthur, Switzerland in early November 2019. A large part of the meeting was spent discussing the development of alternative methods to the in vivo SPF test – ISO 24444.
In the European Union, there are recommendations that require that alternatives to the use of human volunteers be pursued for the testing of sunscreens. At the present time there is no formally accepted In vitro SPF test method with equivalence to In vivo SPF. A project team at ISO spent 7 years attempting to achieve this, but the Work Item was, on two occasions, rejected in the final ISO process mainly due to lack of evidence of equivalence to the current “gold standard” ISO 24444 SPF method which uses human test subjects. At present, 2 In vitro SPF methods, ISO 23675 (1) and ISO 23698 (2) are under development as Work Items. These have not proceeded to the point of being voted on as acceptable substitute methods, so the question of utility and regulation remains open at this point in time.
Both in vitro methods have been supported by publications and an outline of the methodology and can be seen (3,4), even though the drafting of the 2 in-vitro methods is not complete. It is possible to compare these two methods with the in vivo SPF method.
Comparison of 3 SPF Test Methods
|
Parameter of test method |
ISO 23675 In Vitro SPF Test Method(1) |
ISO 23698 DRS SPF Test Method(2) |
ISO 24444 In vivo SPF Test(5) |
|
Invasive Test |
No |
No |
Yes |
|
Application of Test Sample |
By syringe or equivalent |
By syringe or equivalent |
By syringe or equivalent |
|
Spreading of Sample |
Using robotics |
By finger |
By finger |
|
Substrate for test |
PMMA Plates - 2 Types |
Human back |
Human Back |
|
Protection measured by |
Calculation from UV Spectra |
Calculation from UV Spectra |
Visual assessment of Erythema |
|
Products Tested to date |
>148 |
>200 |
All types |
|
Types of Products Tested |
w/o, o/w emulsions Mineral sunscreens |
Broad range |
All types |
|
Correlation with In vivo SPF |
R2 = 0.88. (1) |
R = 0.978. (2) |
“Gold standard” |
|
Measures SPF |
Yes |
Extrapolation |
Yes |
|
Water Resistance Test Capability |
No |
Yes |
Yes |
|
Use of SPF number to perform ISO 24443 Broad Spectrum |
No |
Yes |
Yes |
Adoption of in vitro methods
Whilst there is no doubt that CEN will adopt the ISO 23675 method, the process of mirror adoption by each country member within the E.U. requires individual action. For the HDRS method - ISO 23698 – adoption of this will result in there being two perhaps competing methods for in vitro SPF dominance.
In other countries, the position remains more open. For example, Japan (JCIA) is unlikely to recognise in vitro in the short to medium term, whilst in the USA, Australia and other countries, where sunscreen is regulated as therapeutics are, the in vivo test is likely to prevail.
The legal implications will then become very cloudy, especially in cases where there is legal challenge to reliance on in vitro results on one side which may well be in conflict with in vivo on the other.
There is no doubt that both of these new methods will prove to be useful R&D tools but the question as to whether there will be a complete substitution of the “gold standard” in vivo test is still open.
Second edition of standard ISO 24444 for sun protection products
ISO 24444: 2019 relating to sun protection test methods - in vivo determination of the sun protection factor (SPF) - was published in December 2019 on the ISO website.
This document defines a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. It is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
The main changes from the previous edition are as follows:
- The definition of the minimal erythema response (MED) criteria has been revised
- The choice of eligible test subjects is now based solely on individual typology angle (ITA°) with a requirement for the average ITA° of the test panel to be within the range 41° to 55°, with a minimum of three subjects within two of the three ITA° ranges
- The ITA° is used to define the range of unprotected MED doses, for the provisional or the test day, unprotected MED determination (if no provisional MEDu determination is made)
- Three new reference standard sunscreens have been validated and added to the method to validate SPF test panels for products with SPF equal to 25 or higher (P5, P6 and P8)
- New test methods are provided to determine the uniformity of the beam of both large and small beam size solar simulators. A requirement for uniformity greater than or equal to 90% has been added
- Fluorescent lamps may not be used as a sole source for visual assessment. Incandescent light bulbs or LED lamps are recommended
- Sunscreen application procedures have been described in greater detail
- An informative Annex F has been added with photographic examples of erythema responses with guidelines for grading
- The reporting tables in Annex G and the requirements in Clause 11 have modified to provide more complete information on the results of the testing
- The bibliography has been updated
Please find below a table summarising the most recent regulatory proposals made to the European Commission (Non-exhaustive):
|
Notification number |
Countries |
Title |
|
Korea |
Proposed amendments to the Enforcement Rule of the Cosmetics Act The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is amending the Enforcement Rule of the Cosmetics Act as the following: - The wording "functional cosmetics that help relieve dry skin caused by atopic dermatitis" would be replaced by "functional cosmetics that help ease itchy skin by supporting the recovery of skin barriers |
|
|
Brazil |
Draft Resolution 758, 19 December 2019 It proposes the updating of the technical requirements for the labelling of personal hygiene products, cosmetics, and perfumes |
Recent publications by European Commission
The below table summarises recent publications by the Official Journal of the European Union relating to:
|
Date |
Reference |
Title |
|
13-12-2019 |
Corrigendum to 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 (Official Journal of the European Union L 307 of 28 November 2019)
OJ L 324, 13.12.2019, p. 80–88 (BG, CS, DA, DE, ET, EN, FR, LV, LT, MT, PT, RO, SL, FI, SV) |
Recent SCCS publications on Cosmetics
Following recent publications made by the Scientific Committee on Consumer Safety (SCCS) on cosmetics ingredients, please see the below Preliminary and Final Opinions:
Preliminary opinions:
- SCCS - Preliminary Opinion open for comments on Zinc Pyrithione (ZPT) - deadline for comments: 24 February 2020
- SCCS - Preliminary Opinion open for comments on hair dye Indigofera tinctoria (C170) - Submission III - deadline for comments: 13 March 2020
Final opinions:
- SCCS - Final Opinion on Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (S87) - Submission II
- SCCS - Final Opinion on Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1- dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6- dibromophenol (C183) - Submission IV
Please see the below table summarising the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):
(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.
|
Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
|
Tattooing - Safe and hygienic practice |
2020-07-31 |
|
|
|
Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2019) |
2020-07-31 |
Please find below a table summarising the most recent technical publications on food contact materials (non-exhaustive):
|
Date |
Countries |
Entity |
Title |
|
13-12-2019 |
BfR |
How much aluminium passes through the skin? The BfR reviews a new expert opinion |
1,4-dioxane prohibited in cosmetic products and personal care products
On the 9th December 2019, the New York Governor signed the bill S.4389-B/A.6295-A that prohibits 1,4-dioxane in cosmetic products, personal care products and household cleansing products. The aim is to prevent water contamination.
It will take effect on the 1st January 2022.
For more information view the New York State website here.
Public meeting on talc ingredient
On the 9th January 2020 the Food and Drug Administration (FCA) announced a public meeting - “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.”
Talc is an ingredient used in many cosmetics products and other products such as foods, ceramics, art materials and medical devices, etc… and the possibility that it contains asbestos questions its safety as an ingredient.
The aim of this meeting is to discuss and obtain scientific information related to testing methodologies, terminology and criteria that can be applied to characterise and measure asbestos and other harmful contaminants in talc as an ingredient.
Click here to view the preliminary recommendations on testing methods for asbestos in talc and consumer products containing talc by the FDA.
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 21 alerts regarding Cosmetic & Personal Care products have been reported, from week 1 until week 3 of 2020.
|
Type of Risk |
Number of alerts |
Notes |
|
Chemical |
21 |
Hair dye: It contains sodium perborate which releases boron and an excessive amount of p-phenylenediamine (PPD) |
|
Hair dye: It contains preservative 2-phenoxyethanol that may cause sensitization, irritation, contact allergic reactions |
||
|
Skin lightening product: Containing mercury |
||
|
Skin lightening product: Containing hydroquinone |
||
|
Skin lightening product: Containing betamethasone |
From the 21st December 2019 to the 20th January 2020, the CPSC (Consumer Product Safety Commission) has published the following recalls: 0 recall regarding Cosmetic & Personal Care products.
CBD Testing by Eurofins Cosmetics & Personal Care Canada
Eurofins Cosmetics and Personal Care Toronto can conduct all the testing necessary to bring your CBD product to market:
Cannabis Products
- Method validation analyzing reaction of cannabinoid in a given formula
- Quantification of actives
Cosmetic and Personal Care Testing
- Heavy metals
- Microbiology
- Advanced stability studies
- Preservative effectiveness
- Allergens
- Active substances (ie Zinc Oxide, Fluoride, Aluminum)
Regulatory Affairs and Consulting
- Ongoing Quality Control & Quality Assurance Services
- Label Review
- Communication support with Regulatory Bodies
- Support during product lifecycle: development, launch, post-marketing
- Notification / Declaration / Registration of raw materials and products
Eurofins | CRL, Inc. offers Client GCP (Good Clinical Practice) Training
The goal of this training is to provide professionals in the cosmetic industry with a solid background in Good Clinical Practice (GCP) Guidelines. General topics are discussed, including relevant historical events that have led to the creation of the GCP guidelines, national legislation, along with other international standards. The training is broken into two parts; information in the GCPs that relates to pre-study conduct and events that take place during a study and after a study is completed. The first part of the training includes, but is not limited to, study conduct responsibilities being assigned to relevant parties, proper recruiting methods, protocol generation and approval, and ethics committee involvement.
The second part of the training will go over any items that take place during a study or after a study is completed. This includes, but is not limited to, protocol adherence, proper documentation of protocol changes, the informed consent process, subject confidentiality, safety reporting, archival or documentation of test material upon study completion, and reporting study results.
Eurofins | CRL, Inc. at CEW Product Demo
Eurofins | CRL, Inc. will be sponsoring and exhibiting at this year’s CEW Product Demo. The event gives CEW members exclusive access to view the Beauty Award entries and a chance to meet people in the industry. The event takes place in NYC on February 27, 2020. We hope to see you there!
Eurofins Cosmetics & Personal Care at Cosmoprof Bologna
Meet the Eurofins Cosmetics & Personal Care team at booth D2, Hall 16, during the Cosmoprof Bologna exhibition which will take place from 12 to 15 March 2020 at Bologna Fiere in Bologna, Italy.
Learn how to best manage container content interactions - Eurofins webinar, on March 26th
In collaboration with Cosmetic Valley, Eurofins Cosmetics & Personal Care will present a “Container-Content Interactions: how to go about it? What to do at the very least?” webinar on March 26th at 11am.
Eurofins will present ‘An absence in sensitising potential: how to deal with it, excluding the HRIPT test’ at the COSMED Regulatory Meeting, on March 26th in Paris
Our French safety experts will take part in the COSMED Regulatory Meeting to be held on March, 26th in Paris. Sarah Julienne, Head of In Vitro Laboratory and Adeline Nalin, Head of Safety and Regulatory Affairs, will present the following topic ‘An absence in sensitising potential: how to deal with it, excluding the HRIPT test'.
In order to comply with cosmetic regulation n°1223/2009, several alternative methods to animal testing have been validated or are at advanced stages in the validation process, to assess In vitro skin sensitisation. To comply with cosmetic regulation n°1223/2009, a new concept has been validated by the OECD, named the AOP (Adverse Outcome Pathway).
What are the main strategies employed to evaluate a cosmetic ingredient or a finished product? In the long term, will in vitro tests on 3D models be capable of replacing regulatory HRIPT tests to evaluate the allergenic potential of a finished product?
