10 Aug 2018
EU Adopts New Regulation on Cosmetics Aimed at Restricting Use of Fragrance Ingredients and Fragrance Compounds in Leave-on and Rinse-off Products
On 1 August 2018, Commission Regulation 2018/978 entered into force, having as its aim the amendment of the EU’s framework Regulation on Cosmetic Products (Regulation 1223/2009) with regard to fragrance ingredients. The new Regulation’s application to economic operators, including sellers of cosmetic products, will begin after a transition period, allowing for industry to adapt to the new measures.
Hong Kong’s cosmetic producers exporting to the EU may have become familiar with framework Regulation 1223/2009, which was adopted 9 years ago and has been amended several times since then, always with a view to ensuring the safety of cosmetic products. 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. Pursuant to the framework 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.
New Regulation 2018/978 now states that Tagetes erecta, Tagetes minuta and Tagetes patula, which are fragrance ingredients and fragrance compounds widely used in perfumery, will need to be either restricted or phased out entirely in cosmetics placed on the EU market.
This new Regulation 2018/978 was adopted due to the potential risks those substances were found to possess for humans, as concluded by the EU’s Scientific Committee on Consumer Safety (SCCS) in its first opinion of 21 June 2005 and its revised opinions of 25 March 2015 and 13 December 2017.
The SCCS concluded that the use of Tagetes minuta and Tagetes patula flower extracts and flower oils should be restricted and only used in a maximum concentration of 0.01% in leave-on products and 0.1% in rinse-off products. These maximum concentrations apply whether one or both substances are used. The SCCS also found a potential risk to human health from the use of those extracts and oils where the content of alpha terthienyl (terthiophene) in the extracts and oils exceeds 0.35%.
In addition, the SCCS concluded that those substances should not be used in any concentration in sunscreen products and products marketed for exposure to natural/artificial UV light.
Moreover, the SCCS found that there is a potential risk to human health arising from Tagetes erecta flower extract and Tagetes erecta flower oil in cosmetic products, concluding that these ingredients should therefore be prohibited in cosmetic products.
In light of the SCCS’s conclusions, Annexes II and III of framework Regulation 1223/2009 have been amended accordingly. While Tagetes erecta flower extract and Tagetes erecta flower oil have been added to the list of prohibited substances in Annex II to Regulation 1223/2009, Tagetes minuta and Tagetes patula flower extracts and flower oils have been added to the list of restricted substances in its Annex III.
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 needs to be deferred.
It should be noted that, with regard to the restrictions on the use of Tagetes minuta and Tagetes patula, and the prohibition on the use of Tagetes erecta, from 1 May 2019 only cosmetic products which comply with Regulation 2018/978 shall be placed on the EU market; and, from 1 August 2019 only cosmetic products which comply with the Regulation shall be made available on the EU market.