18 Jan 2019
EU Adopts New Regulation on Cosmetics Restricting the Use of Preservatives in Leave-on And Rinse-off Products
Hong Kong’s cosmetics producers exporting to the EU will have become familiar with the Commission Regulation 2018/1847 amends Annex V (preservatives) of Regulation 1223/2009 on cosmetic products (“the Framework Cosmetics Regulation”), which was adopted in 2009 and has been amended several times since then, always with a view to ensuring the safety of cosmetic products.
Pursuant to the Framework Cosmetics Regulation, ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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 Framework Cosmetics Regulation regulates which substances are allowed to be used in cosmetic products, as well as the conditions under which they can be used. More specifically, the Regulation’s Annexes II and III provide a list of substances which are prohibited or restricted in cosmetic products. These lists are amended from time to time, when – for example – it is found that a specific substance poses a potential risk to human health.
In addition, the Framework Regulation contains specific lists for colourants (Annex IV), preservatives (Annex V), and UV-filters (Annex VI). Any colourants, preservatives, or UV-filters which are not listed in those Annexes, or which do not comply with the requirements set out therein, are prohibited throughout the EU.
The Regulation provides for the European Commission to revise those lists, for the purposes of adapting them to technical and scientific progress. It is with this aim that the European Commission has adopted new Regulation 2018/1847, which amends Annex V relating to preservatives.
Under the currently existing requirement, the substance Biphenyl-2-ol, also referred to as o-Phenylphenol and its salts (MEA o-Phenylphenate, also referred to as 2-aminoethan-1-ol; 2-Phenylphenol, Potassium o-Phenylphenate, also referred to as Potassium 2-biphenylate; and Sodium o-Phenylphenate, also referred to as Sodium 2-biphenylate) are allowed as preservatives in cosmetic products up to a maximum concentration of 0.2% (as phenol) in ready for use preparations under entry 7 of Annex V to the Framework Cosmetics Regulation.
However, regarding the use of o-phenylphenol as a preservative, the Scientific Committee on Consumer Safety (“SCCS”) found in its opinion of 25 June 2015 that there might be a potential for injury to the vision system attributable to o-phenylphenol. The Committee concluded that a maximum concentration of 0.2% in leave-on cosmetic products is not safe, but that a maximum concentration of 0.15% in such products can be considered safe. On the other hand, with regard to rinse-off cosmetic products, the Committee held that a maximum concentration of 0.2% is considered safe.
In light of the above-mentioned SCCS opinion, entry 7 of Annex V of the Framework Cosmetics Regulation is amended to allow the use of o-Phenylphenol as a preservative with a maximum concentration of 0.15% in leave-on and 0.2% in rinse-off cosmetic products.
In addition, for both types of product, “Avoid contact with eyes” must be mentioned as a warning.
An addendum to the above-mentioned SCCS opinion, adopted on 21-22 February 2018, states that the conclusions on the safe-use levels of o-Phenylphenol cannot be applied as such to its salts. According to the SCCS, Sodium o-Phenylphenate, Potassium o-Phenylphenate and MEA o-Phenylphenate may have potentially more potent toxic effects than o-Phenylphenol due to greater skin penetration.
The SCCS concluded that a potential risk to human health from the use of these substances as preservatives in cosmetic products cannot be excluded. Therefore, the use of Sodium o-Phenylphenate, Potassium o-Phenylphenate and MEA o-Phenylphenate as preservatives will no longer be allowed.
Hong Kong’s cosmetics suppliers may be relieved to know that, so as to allow the industry to make the necessary adjustments to product formulations and to adapt to the new prohibitions and restrictions, the application of the above-mentioned measures will not take immediate effect.
Regarding the restriction on the use of Biphenyl-2-ol, from 17 June 2019 only cosmetic products which comply with the new Regulation shall be placed on the EU market; and, from 17 September 2019 only cosmetic products which comply with the Regulation shall be made available on the EU market.
Concerning the ban on its salts, the same dates apply: from 17 June 2019 onwards, cosmetic products containing Sodium o-Phenylphenate, Potassium o-Phenylphenate and MEA o-Phenylphenate as preservatives shall not be placed on the EU market, and from 17 September 2019, they shall not be made available on the EU market.