Cosmetics & Personal Care | Monthly bulletin | May 2020
Regulatory news - Eurofins updates - Commercial news
Recent publications by the European Commission
The below table summarises recent publications by the Official Journal of the European Union relating to cosmetics products:
|
Date |
Title |
|
30-03-2020 |
Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.) |
Recent SCCS publications on cosmetics
The following recent publications were made by the Scientific Committee on Consumer Safety (SCCS) on cosmetics ingredients:
- SCCS - Final opinion on the safety of aluminium in cosmetic products Submission II
- SCCS - Final opinion on hair dye Indigofera tinctoria (C170) CAS 84775-63-3 Submission III
And below SCCS mandate:
Various measures relating to the fight against the spread of COVID-19
In March the French authorities published several decrees relating to hydro-alcoholic products in response to the COVID-19 pandemic. The decrees are as follows:
- The decree of March 6, 2020 (JORF n°0057 of March 7, 2020 text nº18) on various measures relating to the fight against the spread of the COVID-19 virus. This decree indicates that hydro-alcoholic solutions intended for human hygiene may be prepared, in the event of a shortage of supply, by pharmacies for indoor use as referenced in Articles 5125-1 and L.5126-1 of the public health code
- The Decree of March 6, 2020 (JORF nº 0057 of March 7, 2020 text nº17) authorising by derogation the temporary availability and use of certain hydro-alcoholic products as disinfectant biocides for human hygiene
- The decree of March 13, 2020 (consolidated version as of March 27, 2020) authorising by derogation the provision and temporary use of certain hydroalcoholic products as disinfectant biocides for human hygiene. 4 formulas are outlined for hydro-alcoholic products. For cosmetic companies with manufacturing facilities, it is advisable to scrupulously respect the outlined formulations, labelling notices as well as all other conditions of this decree so that no additional declaration needs to be made for the manufacture of hydro-alcoholics products. Please be aware that formulas 3 and 4 are recommended for a cosmetic company, as they are more similar to cosmetic product compositions
- The decree of March 14, 2020 (modifying the decree n ° 2020-197 of March 5, 2020) fixes the sale price of hydro-alcoholic products
At the same time, the Stopcovid19.fr platform has secured an order of more than 300,000 litres of gels and hydro-alcoholic solutions. For more information, please visit the economie.gouv.fr website here.
Please find below a table summarising the most recent technical publications on food contact materials (non-exhaustive):
|
Date |
Country |
Entity |
Title |
|
03-04-2020 |
France |
ANSES |
ANSES proposes identifying resorcinol as a proven endocrine disruptor for humans |
Temporary policy for hand sanitizer products
In March 2020, The U.S. Food and Drugs Agency published the following guidance for industry in relation to the shortage of alcohol-based hand sanitizer products during the COVID-19 pandemic:
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry
Regulatory proposals notified to WTO
Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):
|
Notification number |
Countries |
Title |
|
Canada |
Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing
In light of the unprecedented demand and urgent need for products that can help limit the spread of COVID-19, Health Canada is facilitating access to products that may not fully meet current regulatory requirements, as an interim measure |
|
|
Brazil |
Resolution – RDC number 347, 19 March 2020
This resolution establishes temporary and exceptional criteria and procedure for the sale of antiseptic preparations and sanitizers due to the international public health emergency related to the SARS-CoV-2 |
|
|
Brazil |
Draft Resolution number 805, 27 March 2020 (9 page(s), in Portuguese) Comment form:
This resolution establishes administrative procedure for the concession of Good Manufacturing Practices Certification for medicines, medical devices, personal hygiene products, cosmetics, perfumes, sanitizers, active pharmaceutical ingredients, and food; and Good Practices of Storage and Distribution Certification for medicines, medical devices, and active pharmaceutical ingredients |
|
|
Europe |
Draft Commission Regulation amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
This draft Commission Regulation would restrict nail products containing HEMA/Di-HEMA to professional use only and the following warnings "for professional use only" and "Can cause an allergic reaction" should be displayed on packaging |
|
|
Europe |
Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up
The restricted substances are:
|
|
|
Korea |
Proposed amendments to the 'Labelling Standards for Cleansing & Hygiene Products'
The main points are:
|
|
| G/TBT/N/PHL/232 |
Philipines |
New Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services, Amending Administrative Order No. 50 s. 2001, "Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs"
Additional guidelines on FDA services particularly in relation to fees and charges, validity of License to Operate (LTO), Certificate of Product Registration (CPR), Foreign Good Manufacturing Practice Certificate (FGMP), among others |
| G/TBT/N/TPKM/410 |
Taiwan |
Amendment to the List of Colorants in Cosmetic Products (Draft)
In order to ensure the safety of cosmetic ingredients in relation to human health and compliance with global cosmetic trends, the Food and Drug Administration is proposing to amend the regulatory requirements for the use of limited dosage of ingredients in cosmetics products |
| G/TBT/N/CHE/244 |
Switzerland |
General Ruling of the Notification Authority for Chemicals on the authorisation of biocidal products in exceptional situations according to Art. 30 of the Ordinance on the Placing on the Market and Handling of Biocidal Products of 18 May 2005
General Ruling No.2 of the Notification Authority for Chemicals on the authorisation of biocidal products in exceptional situations according to Art. 30 of the Ordinance on the Placing on the Market and Handling of Biocidal Products of 18 May 2005
The general rulings of the Notification Authority for Chemicals grant a general authorisation to place on market certain disinfectants comprised of alcohol or active chlorine. The authorisations are limited to 31 August 2020 |
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 5 alerts regarding Cosmetic and Personal Care products have been reported, from week 8 to week 11 of 2020.
|
Type of Risk |
Number of alerts |
Notes |
|
Chemical |
5 |
Skin cleansing product: It contains an excessive amount of formic acid and boric acid. Does not comply with Cosmetic Products Regulation |
|
Tattoo ink: It contains the aromatic amine o-anisidine, nickel and an excessive amount of copper |
||
|
Skin lightening product: It contains clobetasol propionate, which is a corticosteroid that requires medical prescription |
From the 16th February 2020 to the 15th March 2020, the CPSC (Consumer Product Safety Commission) has published the following recalls: 4 recalls regarding Cosmetic and Personal Care products.
|
Type of Risk |
Number of alerts |
Notes |
|
Poisoning |
4 |
Essential oil: It contains the substance methyl salicylate which must always be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA) |
Eurofins Cosmetics & Personal Care | Reopening Plans
As the confinement measures are starting to show positive effects in containing the virus in several countries, all Eurofins Cosmetics & Personal Care teams are working hard to prepare robust safety measures for application at the end of the lockdown, based on the latest recommendations from local and global health authorities.
Compliance with the regulation of your target market is a key step in order to ensure you gain timely and full market access.
Compliance for Cosmetic Packaging
Plastic packaging for cosmetic products is important, both from a provision of information and advertising perspective, and also its role in protecting and prolonging the shelf life of cosmetic products.
Risk Assessment – Cosmetic Packaging
As a result of the constant innovation and changing landscape of cosmetic products, the issue of risk assessment in terms of cosmetics product packaging can present a real challenge.
