Clashing Provisions of EU Regulations Pose Obstacle for Assessment of Cosmetics

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Manufacturers selling cosmetics that contain nanomaterials in the European market face an “insurmountable obstacle to safety assessment” due to an impending ban on animal testing and a requirement to use validated test methods, an EU scientific committee said in a new guidance document.

“At present, validated alternative methods that can be used in place of animal tests are only available for conventional substances, and not for nanomaterials. This poses an insurmountable obstacle to safety assessment of cosmetic nanomaterials,” the European Commission's Scientific Committee on Consumer Safety said. It called for “further research work” in this area.

The committee stated its conclusion in Guidance on the Safety Assessment of Nanomaterials in Cosmetics, which it released July 4.

The document offers guidance on “essential elements” the EU's Cosmetics Regulation ((EC) No. 1223/2009) require to be included in safety dossiers submitted to the Commission for many cosmetics containing nanomaterials.

Nanomaterials that are exempted from the requirements include those used as colorants, ultraviolet light filters, or preservatives.

For nanomaterials included in cosmetics for other purposes, Article 16 of the regulation requires specific information to be submitted beginning Jan. 11, 2013. This information includes:

• details on the nanomaterial, including size of the particles and physical and chemical properties;

• data from toxicity studies; and

• reasonably foreseeable exposure conditions.


The Scientific Committee's guidance includes a chart listing types of measurement methods that companies could use to provide much of the identity, size, and other chemical characterization information required.

Industry Faces Conundrum

Cosmetics manufacturers face a conundrum, however, when they seek to comply with two apparently clashing requirements in the cosmetics regulation, the committee said.

The EU's Cosmetics Directive (76/768/EEC), which will be replaced by the EU's Cosmetics Regulation as of July 11, 2013, has been phasing out animal testing for years.

A total prohibition on the EU sale of cosmetics that have been tested using animals--or which have ingredients that have been tested using animals--is set for March 2013.

The law also requires that safety assessment data for nanoscale substances in cosmetics--as well as conventional chemicals--come from “validated” toxicological test methods.

'None of the Methods Validated for Nanomaterials'

“A limited number of in vitro test methods have been developed and validated for conventional chemicals to assess various toxicological endpoints … but none of the methods has yet been validated for nanomaterials,” the guidance said.

“The complete ban on in vivo testing of cosmetic ingredients and products in 2013 poses an obstacle to the risk assessment of cosmetic ingredients in general, and ingredients in nanomaterial form in particular,” the committee said.

The committee voiced a similar concern in an opinion it issued in 2008 (32 CRR 236, 3/10/08).

Regulators to Discuss Nanomaterials at ICCR-6

Safety testing for nanomaterials in cosmetics is among the issues slated to be discussed by regulators and industry at the sixth International Cooperation on Cosmetics Regulation (ICCR-6), which will take place July 10-13 in Rockville, Md. (36 CRR 551, 5/21/12).

People for the Ethical Treatment of Animals (PETA) provided BNA with a statement that concluded the obstacle the guidance discusses may not be as insurmountable as the guidance suggests.

PETA said the guidance discussed a study released in 2011 on the use of in vitro tests for skin corrosion, phototoxicity, dermal penetration, skin and eye irritation, and other conditions.

PETA to Companies: Develop Valid Test Methods

The 2011 finding “showed that alternative methods can be useful for hazard identification of nanomaterials but will need optimizing for each of the nanomaterials evaluated,” PETA said, quoting the scientific committee's guidance.

Nevertheless, animal test methods are not validated to be used for nanomaterials and are scientifically unreliable due to problems with dosing, tracking, and measurement of nanomaterials within animals' bodies, PETA said.

That said, “the European public has made its position clear--they do not want animals to suffer and die for a new shade of lipstick or eyeliner. The Commission must take an ethically and scientifically responsible stance and require that companies wishing to market nanomaterial-containing cosmetics develop valid in vitro methods, and submit those data in order to uphold the ban on animal testing for cosmetics in the EU,” PETA said.

The Personal Care Products Council, which represents U.S. cosmetics companies, was closed July 5 and 6 and unable to comment.

Cosmetics Europe--The Personal Care Association, previously known as Colipa, told BNA July 6 it could not comment because it is still reviewing the committee's guidance.

Best Practices Set by Guidance Documents

Lynn Bergeson, an attorney with Bergeson and Campbell, P.C., also was still reviewing the guidance, but based on a preliminary review, she said the document “renews much of what has been stated before, namely much more information is needed, more methods and protocols need to be configured to address nanomaterials, and the state of the science is evolving.”

“Companies in this commercial space will need to be especially mindful of guidance documents like these as best practices will be measured against them and they become the de facto 'business norm' in the absence of more,” Bergeson said.

By Pat Rizzuto  

Guidance on the Safety Assessment of Nanomaterials in Cosmetics is available at

Attendance at ICCR-6 is limited due to space considerations. For information, contact Rosemary Cook in FDA's Office of Cosmetics and Colors at (240) 402-1129 or

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