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Media Centre >> News >> Eurofins | May 2019 regulatory Newsflash compilation | Cosmetics & Personal Care

Eurofins | May 2019 regulatory Newsflash compilation | Cosmetics & Personal Care

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Monday, May 13, 2019

Eurofins newsflash Cosmetics and Personal Care




Chemicals restriction in tattoo inks


On 20th March 2019, the European Chemicals Agency (ECHA) published the Committee for Socio-Economic Analysis (SEAC) conclusion about the hazardous chemicals restriction in tattoo inks and permanent make-up. 


SEAC gave support to the proposal by ECHA to restrict the placing on the market and use of hazardous substances in tattoo inks and permanent make-up. Substances within the scope of the restriction include carcinogenic, mutagenic and reprotoxic (CMR) substances, skin sensitisers or irritants, substances corrosive or damaging to the eye, metals as well as other substances regulated in cosmetic products.


For more information click here.


Regulatory updates


Below a summary table with some recent European regulation proposals notified to World Trade Organization:


Notification number



Draft Commission Regulation amending Annex VI to Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products.

This draft Commission Regulation aims at authorising the use of additional coating materials for the UV-filter Titanium dioxide (nano) in cosmetic products.


Draft Commission Regulation amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

This draft Commission Regulation proposes the authorisation of a new preservative ingredient - Hydroxyethoxyphenyl Butanone (HEPB) – in rinse off, oral care and leave-on cosmetic products at a maximum concentration of 0.7%.




No more phenoxyethanol in "non-rinsed" cosmetic products for children


On 20th April 2019, the French Agence Nationale de Sécurité du Médicament et des Prouits de Santé (ANSM) published a decision about "non-rinsed" cosmetic products (excluding deodorants, styling products and make-up products) containing phenoxyethanol as preservative.


According to this decision, these products can only be placed on the market if they state on their labeling that they cannot be used on the buttocks of children 3 years old or under. This decision was taken, as a precautionary measure, in the light of new scientific data on exposure to phenoxyethanol, in order to guarantee the safe use of cosmetic products for children. It must take effect within 9 months.


This is the case, for example, of wipes.  For other products intended for children aged 3 years and under, the maximum concentration of 1% phenoxyethanol is applicable, in accordance with the European Regulation on cosmetic products.


Click here for getting the decision from ANSM’s website.




Reinstatement of Color Additive Listing for Lead Acetate


The Food and Drug Administration (FDA) is reinstating the provision removed in October 2018 to amend the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp.


FDA is reinstating this provision only because it was removed from the Code of Federal Regulations (21 Code of Federal Regulations (CFR) 73.2396) before FDA had the opportunity to take final action on the objections.


This provision will remain in place pending final FDA action. This action does not reflect any change in the FDA's determination that new data demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.


For more information click here.


New requirements for Antiseptic Rubs


On 12th April  2019, the U.S. Food and Drug Administration (FDA) published the Final Rule for Antiseptic Rubs; these products containing ineligible active ingredients, that are not Generally Recognized as Safe and Effective, will require approval under a new drug application (NDA) or abbreviated new drug application (ANDA) prior to marketing.


It shall be effective from 13th April 2020.


For more information click here.


US | Maine


Proposal to designate PFOS as Priority Chemical in children’s products


The Maine Department of Environmental Protection has recently proposed a draft rule (“Chapter 890: designation of PFOS as priority chemical”).  This chapter would designate perfluorooctane sulfonic acid (“PFOS”) as a priority chemical and would require reporting for certain children’s products containing PFOS.


No later than 180 days after the effective date of this chapter, or within 30 days of the sale of the children’s product within the State of Maine, manufacturers and distributors would be required to report to the Department if the regulated chemical is intentionally added to the following product categories and exceeds the practical quantification limit (PQL), pursuant to section 4(B) of this chapter with some exemptions:


  • Childcare article
  • Children’s clothing
  • Children’s footwear
  • Children’s sleepwear
  • Children’s toy
  • Cookware, tableware, reusable food and beverage containers
  • Cosmetics and personal care products
  • Craft supplies
  • Electronic device
  • Household furniture and furnishings

The following information would have to be reported to the Department:


  • Name and address of the manufacturer or distributor.
  • Name, address, and phone number of a contact person for the manufacturer or distributor.
  • A description of product that contain PFOS.
  • Amount of PFOS in each unit of the product reported.
  • Function of PFOS in the product reported.
  • Number of product units sold or distributed in Maine.
  • Any other relevant information.

Comments can be submitted by May 6, 2019. For more information, click here.




New Testing Methods added to Safety and Technical Standards for Cosmetics (2015)


On 22nd March 2019, the National Medical Products Administration (NMPA) of China released the Notice No. 2019-12. In this notice, a total of 9 testing methods, including 5 new methods and 4 revised methods, have been published and included in the Safety and Technical Standards for Cosmetics (2015).


An overview of the 9 testing methods can be found as follows:



Testing method



Determination of free formaldehyde in cosmetics

New added


Short Time Exposure In Vitro Test Method (STE)


Skin Sensitization: Local Lymph Node Assay: DA(LLNA:DA)


Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA)


In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)


Determination of Cantharidin and Chlormethine in Cosmetics



Determination of 10 α-hydroxy acid in cosmetics


Bacterial Reverse Mutation Assay


Teratogenicity Test


Starting from January 1, 2020, these testing methods should be adopted for testing cosmetics for registration, filing and post-market surveillance.


The complete notification can be found here (in Chinese).




Regulatory updates


Below a summary table with some recent regulation proposals notified to World Trade Organization:


Notification number





Guía Referencial para la Evaluación de Seguridad de Productos Cosméticos, para la Higiene Personal y Perfumes.


(Reference guide to safety assessment for cosmetic and personal hygiene products and perfumes).



National Standards of the P.R.C., Wooden Toothpick.



Proposed amendment to the "Regulation on Quasi-drug Approval, Notification and Review".



Proposed amendments to the "Standards for Organic Cosmetics".



Proposed amendments of the "Enforcement Decree of Cleansing & Hygiene Products Control Act".



Cosmetic Good Manufacturing Practice Regulations (Draft).



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”).




RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).


The following 21 alerts regarding cosmetic products have been reported, from week 12 until week 16 of 2019.


Type of Risk

Number of alerts






Cosmetics products containing some of the following substances:

  • Butylparaben
  • Colorants Solvent Yellow 172, CI 45161, CI 45174 and CI 74620
  • Diethylene glycol (DEG)
  • Formaldehyde
  • A mixture of the preservatives methylchloroisothiazolinone and methylisothiazolinone
  • The aromatic amine o-anisidine
  • Clobetasol propionate
  • Zirconium, barium and lead


Tattoo ink products containing some of the following substances:

  • Aromatic amine o-anisidine
  • Polycyclic aromatic hydrocarbons (PAH)s
  • Benzo(a)pyrene
  • Toluidine



Cosmetic products having the following microbiological contamination:

  • Aerobic mesophilic bacteria and yeast and mould
  • Pseudomonas putida




From on 21st March to 20th April 2019, CPSC (Consumer Product Safety Commission) has published the following recalls0 recalls regarding cosmetic products.