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Regulations Adopted Amending Lists of Substances Allowed in Makeup Products, Mouthwashes and Sunscreens

Hong Kong’s exporters of cosmetic products may be interested to know that the European Commission has recently adopted three Regulations applicable EU-wide, which amend the lists of substances the use of which is permitted in cosmetic products. These lists of permitted substances are included in Annexes to framework Regulation 1223/2009 on cosmetic products (the Cosmetic Products Regulation). The three recently adopted Regulations will slightly modify those Annexes.

First, Regulation 2016/1120, published on 12 July 2016, amends the list containing the colorants which are allowed to be used in cosmetics. Second, Regulation 2016/1121, also published on 12 July, amends the list of permitted preservatives. Finally, Regulation 2016/1143, which was published on 14 July 2016, modifies the list of UV-filters allowed in cosmetic products.

Hong Kong traders may be familiar with the Cosmetic Products Regulation, which was adopted in 2009 in order to harmonise the EU rules on cosmetic products. This framework Regulation applies to all cosmetic products (but not to medical or biomedical products) which are made available on the EU market. The Regulation defines cosmetic products as any substance or mixture 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 with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Part of the Cosmetic Products Regulation regulates which substances are allowed to be used in cosmetic products, as well as the conditions under which they can be used. The Annexes to the Regulation contain a list of prohibited substances (Annex II) and a general list of restricted substances (Annex III).

In addition, the Regulation contains specific lists for colorants (Annex IV), preservatives (Annex V), and UV-filters (Annex VI). Any colorants, preservatives, or UV-filters which are not listed in those Annexes, or which do not comply with the requirements set out therein, are prohibited all over the EU. The Regulation provides for the European Commission to revise those lists, for the purpose of adapting them to technical and scientific progress. It is for this purpose that the European Commission has adopted the three new Regulations, which amend these three specific lists.

Regulation 2016/1120 amends Annex IV to the Cosmetic Products Regulation, containing the list of permitted colorants, as well as the restrictions related to their use. The substance Carbon Black is included in the list. Carbon Black is used in different types of cosmetic products, specifically makeup products, including eyeliners, eye pencils, eye shadows, mascaras, blushers, brush-on-brow, foundations and nail enamels. However, Carbon Black in its nano-structured form has not yet been allowed. The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion that Carbon black (nano) does not pose a risk when applied on healthy, intact skin. Consequently, the European Commission has now added Carbon Black (nano) to Annex IV, subject to a number of conditions. The most important condition is that the substance may not be used in applications which can be inhaled by the end-user. Hong Kong traders who are interested in knowing the other conditions, are advised to consult the text of Regulation 2016/1120.

In addition, the European Commission considers that the existing conditions for the use of non-nano Carbon Black are outdated. As a result, Regulation 2016/1120 also replaces those conditions with the newly introduced conditions concerning the nano-structured variant. The new conditions concerning the use of Carbon Black (nano) will therefore apply for the use of all Carbon Black. Only the restriction concerning the use in applications which could lead to inhalation is limited to the nano-structured form. The use of the non-nano variant in spray applications will thus continue to be authorised, subject to the other new conditions. Regulation 2016/1120 entered into force on 2 August 2016.

Regulation 2016/1121 amends Annex V to the Cosmetic Products Regulation, which contains the list of preservatives which are permitted, as well as the conditions under which they are permitted. The substance Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride (also referred to as Ethyl Lauroyl Arginate HCL) is currently allowed (up to a maximum concentration of 0.4%), except in oral products, lip products and spray products. The SCCS concluded in its opinion and the addendum to its opinion, that the use of the substance as a preservative is safe in mouthwashes (except for children), but not in other oral products. As a result, the European Commission has specified that the restriction of oral use does not apply to mouthwashes (with a maximum concentration of 0.15%), except when used for children under 10 years of age. Regulation 2016/1121 entered into force on 2 August 2016.

Regulation 2016/1143 amends Annex VI to the Cosmetic Products Regulation, which contains the list of permitted UV-filters, as well as the conditions related to their use. The substance Titanium Dioxide is included in that list. However, Titanium Dioxide in its nano-structured form is not yet permitted. The SCCS concluded in its opinion that the use of Titanium Dioxide (nano) in sunscreens, with certain characteristics (e.g. relating to its purity, structure and physical appearance, etc.) and at a concentration up to 25 % w/w, can be considered safe if applied to healthy, intact or sunburnt skin.

However, according to the SCCS, the use of Titanium Dioxide (nano) in spray applications cannot be considered safe. Consequently, the European Commission has added Titanium Dioxide (nano) to Annex VI, subject to the conditions specified by the SCCS, and excluding applications which may lead to inhalation by end-users. Hong Kong traders interested in the specific conditions, under which this substance can be used in cosmetics, should consult Regulation 2016/1143. The Regulation entered into force on 4 August 2016.

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