Eurofins | Newsflash - May 2018 | Cosmetics

Europe

Microplastics in our daily lives: A growing concern

Microplastics are very small particles of plastic material (typically smaller than 5mm). They can be unintentionally formed through the wear and they can also be deliberately manufactured and intentionally added to products for a specific purpose, such as exfoliating beads in facial or body scrubs. Once released to the environment, they may be accumulated by animals, including fish and shellfish and, consequently, ingested as food by consumers.

Due to growing concern for the environment and human health, several EU Member States have enacted or proposed national bans on the intentional use of microplastics in certain consumer products, mainly uses of ‘microbeads’ in ‘rinse-off’ cosmetic products where they are used as exfoliating and cleansing agents.

The ECHA (European Chemicals Agency) has launched a call for collecting evidences and information about the impacts of microplastics in order to evaluate a possible restriction of microplastics in any kind of products. The call for evidence is open until 11 May 2018.

Click here to access the call for evidence in ECHA website.

Europe

Version 3.1 of the cosmetics working group manual (borderline products)

On 20^th April 2018, the European Commission published the version 3.1 of the Manual of the Working Group on Cosmetics (Borderline products Sub-Group) on the scope of application of the Cosmetics Regulation (EC) No 1223/2009.

Version 3.1 of the Borderline Manual adds the following entries:

Product	Notes
Product against spots	Products that function to prevent the formation of spots or function to protect the face from spots through a cleansing action may fulfill the cosmetic definition depending on how the product is presented, the claims that are made about the product and the ingredients used in the product. Such products should not make any explicit or implicit claims related to the prevention or treatment of acne. Products for spots may also claim ‘suitable for acne-prone skin’ provided undue prominence is not given to the claim
Product against acne	The prevention or treatment of acne or other inflammatory lesions of the skin do not fulfill the definition of a cosmetic product. For example, a product that is presented as an ‘anti-acne’ product should not be marketed as a cosmetic product.
Piercing care products	Piercing care products on pierced skin does not fall within the scope of the Cosmetics Regulation. However, a piercing care product used on pierced "external parts of the human body" which have healed, mainly to clean and /or perfume, without a main antimicrobial or antiseptic function, may fall within the scope of the Cosmetics Regulation.
Wet razors releasing substances/mixtures	A wet razor may be the "vehicle" to deliver a substance or mixture to the human skin; it falls within the scope of application of the Cosmetics Regulation. A lubricating strip which is only aimed to help the blade glide across the skin during shaving may not fall within the scope of application of the Cosmetics Regulation.
Essential oil	Essential oil is defined as a volatile part of a natural product, it contains mostly volatile hydrocarbons. Essential oil which is only intended for use under aromatherapy practices without identifying an exclusive/main cosmetic purpose should not qualify as a cosmetic product. (Pure) essential oils which are intended to be inhaled or ingested would fall outside the scope of the Cosmetics Regulation. (Pure) essential oils may be considered as cosmetic products, provided that they are “intended to be placed in contact with the external parts of the human body […] or with the teeth and the mucous membranes of the oral cavity” and the purpose of their use is “exclusively or mainly cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors”.
Tattoo removal devices	Laser devices intended to remove tattoos do not fulfill the definition of cosmetic product, because a laser device is neither a substance nor a mixture.
Tattoo aftercare products	An aftercare product applied on non-intact skin just after tattooing, which is presented or intended to promote the healing of the skin, the treatment of wounds or the prevention of infection does not have an exclusive or main cosmetic function and thus does not fall within the scope of the Cosmetics Regulation

Europe

Addendum – draft commission regulation amending annex V to cosmetic regulation

Addendums have been added to the public consultation on draft Commission Regulation amending Annex V of the Cosmetics Regulation.

- The first draft was notified by the European Commission to the World Trade Organization (WTO) (ref.G/TBT/N/EU/527) in November 2017 and aimed at amending Annex V of the Cosmetic Regulation by decreasing the concentration of O-PHENYLPHENOL (and its salts) allowed as a preservative in leave-on products.

- The second draft seeks to amend the preambles to the Regulation, in particular to refer to the opinion addendum adopted by the SCCS (Scientific Committee on Consumer Safety) last February (SCCS/1597/18). In addition, while the original draft authorized the use of Sodium o-phenylphenate, Potassium o-phenylphenate and MEA o-phenylphenate, the new project no longer lists them in the appendix and these substances will therefore be banned in cosmetics.

Europe

Draft amendment commission regulation for nanomaterials

On 26^th April 2018, the Draft Commission Regulation amending several Annexes to REACH was voted in the REACH Committee.

The aim of these amendments is to provide more information about the characteristics of nanomaterials, how they are used, how to handle them safely, what risks they potentially pose to health and the environment and how these risks are controlled.

The Draft Commission Regulation is now subject to scrutiny by the Parliament and Council for a period of three months before being adopted by the Commission.

The ECHA recommends familiarising with the amendments and assessing what action needs to be taken to comply with them.

Click here to access the ECHA website.

International

Technical/Scientific framework for the stability of cosmetic products

This year the International Organization for Standardization (ISO) published “ ISO/TR 18811:2018 Cosmetics - Guidelines on the stability testing of cosmetic products”

This document can serve as a technical/scientific framework to identify the most suitable assessment for determining the stability of cosmetic products considering the wide variety of products, storage and use conditions that exist in the market.

Click here to access the ISO website.

Draft alternatives for skin sensitization tests in animals

On 10^th April 2018, the U.S. Environmental Protection Agency (EPA) published a Draft on The Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing.

The public comment period is open until June 9, 2018.

Click here for getting the EPA publication.

US - Vermont

Formaldehyde ban in cosmetic products

Within this year 2018, Vermont State has published several Acts about the formaldehyde ban in cosmetic products. In these acts the following is indicated:

“A person shall not manufacture, distribute, sell, or distribute in commerce in the State a cosmetic that contains:
(1) formaldehyde or formaldehyde equivalents; or
(2) an ingredient that, under normal conditions of the product’s use, releases formaldehyde or a formaldehyde equivalent at a level exceeding 0.05 percent.”

These acts shall take effect on July 1, 2018.

Reference	Date	Journal of the House
S. 251	3/1/2018	By Senator Lyons, An act relating to the use of formaldehyde in cosmetics. To the Committee on Health and Welfare
H.602	11/1/2018	By Reps. Webb of Shelburne, Brumsted of Shelburne, Christie of Hartford, Conlon of Cornwall, Dunn of Essex, Fields of Bennington, Houghton of Essex, Howard of Rutland City, Joseph of North Hero, Morris of Bennington, Ode of Burlington, Scheu of Middlebury, Squirrell of Underhill, Sullivan of Burlington, Townsend of South Burlington and Troiano of Stannard, House bill, entitled An act relating to the use of formaldehyde in cosmetics; To the committee on Human Services.