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Media Centre >> News >> Eurofins | Newsflash - August 2018 | Cosmetics

Eurofins | Newsflash - August 2018 | Cosmetics

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Monday, August 6, 2018



Publication of Regulation (EU) 2018/978 amending Annexes II and III of the Cosmetic Regulation

On 12th July 2018, the European Commission published “Commission Regulation (EU) 2018/978 of 9 July 2018 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products”.


The main points are:

  • Banning the use of TAGETES ERECTA (flower extract and essential oil)
  • Restricting the use of TAGETES MINUTA and TAGETES PATULA (flower extract and essential oil): 0,01% in leave-on products and 0,1% in rinse-off products (both with Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0,35 %)
  • TAGETES MINUTA and TAGETES PATULA (flower extract and essential oil): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light

This new regulation applies starting from 1st May 2019.
Click here to access the Regulation.





12th Commission report on animal testing


On 10th July the European Commission published the “REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2015-2017)”.





Last consultation on harmonised classification and labelling for substances in cosmetic use

ECHA is working in the harmonised classification and labelling of chemical substances in general. Some of these substances can be used in cosmetic industry.  Following a summary table with the substances in consultation related to cosmetic industry:


Chemical name INCI name CAS number Comments

2,2-dibromo-2-cyanoacetamide; [DBNPA]



It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are requested on selected physical hazards, on human health hazard classes except respiratory sensitisation and aspiration hazard, and on environment hazard classes.




It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are requested on the skin sensitisation hazard class.

Pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc

 Zinc Pyrithione


It was submitted by Sweden and was subject to a public consultation, which ended on 7 July 2017.
During its June meeting, the Committee for Risk Assessment (RAC) asked for further information to clarify the aquatic hazard of the substance.
Shortly before the RAC meeting, the zinc pyrithione industry consortium submitted new information on the aquatic toxicity of zinc pyrithione. This included two newly conducted experimental studies on the marine diatom Skeletonema costatum. As the study reports included preliminary results and were clearly marked by the industry representatives as unaudited drafts, the consortium committed to submit to RAC the audited, GLP-compliant full reports for the targeted public consultation.
The consortium submitted this new information to ECHA on 6 July 2018 and 13 July 2018.
All interested parties are invited to submit comments on the subject of the targeted consultation using the webform by 1 August 2018. The comments will be published on ECHA's website.

Click here for going to Harmonised classification and labelling public consultations in ECHA website.





Recent SCCS Opinions on Cosmetics


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





Opinion on health risks of MOSH and MOAH in cosmetic products

On 2nd July, the  German Federal Institute for Risk Assessment (BfR) published the English translation of its opinion 008/2018 about mineral oils used in cosmetic products.
The BfR has evaluated the health risks of dermal absorption of mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH) from mineral oils via cosmetics. Highly refined mineral oils and microcrystalline waxes, which comply with the purity requirements for pharmaceuticals, are used in cosmetic products for dermal application. According to the currently available scientific knowledge, no health risks are to be expected for consumers who apply cosmetic products to their skin, in the view of the BfR.
Click here for getting the English translation of this opinion 008/2018.