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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Cosmetics & Personal Care | Monthly bulletin | May 2020

Cosmetics & Personal Care | Monthly bulletin | May 2020

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Eurofins newsflash Cosmetics and Personal Care

Regulatory news - Eurofins updates - Commercial news 

 

Regulatory news

 


 

Europe

 

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:

 

And below SCCS mandate:

 

 

France

 

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.

 

Technical publications

 

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

 

US

 

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

 

International

 

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

G/TBT/N/CAN/609

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

G/TBT/N/BRA/996

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

G/TBT/N/BRA/997

Brazil

Draft Resolution number 805, 27 March 2020 (9 page(s), in Portuguese) Comment form:
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=54824

 

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

G/TBT/N/EU/707

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

G/TBT/N/EU/709

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:

 

  1. Substances with harmonised classification under Regulation (EC) No 1272/2008 (CLP) as carcinogenicity, mutagenicity or toxicity to reproduction, skin sensitisation, skin corrosion or irritation and serious eye damage or irritation
  2. Substances prohibited by the Cosmetic Products Regulation, Regulation (EC) No 1223/2009 Annex II and Annex IV under specific conditions as listed in its columns g, h and i
  3. Impurities exceeding the concentration limits as listed in the Appendix to the draft Commission Regulation. Application of the restriction is deferred for 1 year to allow for sufficient time to adapt and achieve compliance with the Regulation

G/TBT/N/KOR/888​

Korea

Proposed amendments to the 'Labelling Standards for Cleansing & Hygiene Products'

 

The main points are:

 

  1. Stickers, labels, or tags may be used in the labelling of minor information irrelevant to the safety of the products, except for the date of manufacture and the expiration date, which are approved by the competent authority
  2. The net quantity of contents statement may be expressed in weight, length, numeric count, etc.
  3. Maximum Allowable Variations will be expanded for toilet paper and tissue packages labelled by length
  4. If it is difficult to indicate the manufacture date or the expiration date on the main display surface or information display surface, the location of the manufacture date or the expiration date shall be specified
  5. If cleansing and hygiene products use fragrances containing the raw materials that the Minister of Food and Drug Safety identifies and publicly notifies as allergens, the name of such raw materials shall appear on the product label
  6. When importing products without any indication of the manufacture date from countries where the labelling of manufacture date is not mandatory, the importer shall indicate the manufacture date in Korean based on the evidence data on the manufacture date received from the manufacturing company of the exporting country
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

 

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 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

 

US

 

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)

 

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