29 Nov 2019
EU Adopts Two New Regulations Regulating the Use of Certain Substances in Cosmetic Products
On 27 November 2019, two new Regulations entered into force, amending the EU’s framework legislation, Regulation 1223/2009 on cosmetic products. The new legislation was adopted pursuant to new opinions presented by the EU’s expert committee, the Scientific Committee on Consumer Safety (SCCS). Regulation 1223/2009 is the primary regulatory framework for finished cosmetic products which are placed on the EU market. The European Commission adopts changes to this framework as and when the need arises, in light of scientific and technical progress.
Hong Kong sellers of cosmetics may know that under EU law, a ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body, e.g., the skin, hair, nails, lips and external genital organs, or with the teeth, 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. Cosmetic products may include lotions, gels and oils for the skin and hair, make-up, soaps, deodorant, perfumes and sunbathing products.
Commission Regulation (EU) 2019/1857 was published on 7 November 2019. It amends Annex VI to Regulation 1223/2009 on cosmetic products. Annex VI sets out a “List of UV Filters Allowed in Cosmetic Products” throughout the EU.
Titanium dioxide is currently allowed as a UV-filter in cosmetic products, including in a nanomaterial form. Titanium dioxide (nano) is listed in entry 27a of Annex VI to Regulation 1223/2009 on the safety of cosmetic products. It is allowed at a maximum concentration of 25% in ready for use preparations, except in applications that may lead to exposure of the end user’s lungs by inhalation and subject to the characteristics listed in the entry. The characteristics listed in entry 27a of Annex VI concern the allowed physico-chemical properties of titanium dioxide (nano) and the substances with which it can be coated.
The new Regulation notes that two opinions of 2017 and 2018 found that the use of the three forms of titanium dioxide (nano) namely (i) coated with either silica and cetyl phosphate (up to 16% and 6%, respectively); (ii) alumina and manganese dioxide (up to 7% and 0.7%, respectively), or (iii) alumina and triethoxycaprylylsilane (up to 3% and 9%, respectively), can be considered safe for use in cosmetic products intended for application on healthy, intact or sunburnt skin.
However, the SCCS added that this conclusion does not apply to applications that might lead to exposure of the consumer’s lungs to the titanium dioxide nanoparticles through the inhalation route (such as powders or sprayable products).
The SCCS also opined that the ingredients used in some types of products (e.g. in lipsticks) may be incidentally ingested. The potential harmful effects of manganese dioxide should therefore be taken into account if the manganese dioxide-coated nanomaterials are to be used for applications that could lead to oral ingestion.
In light of the SCCS opinion and in order to take into account technical and scientific progress, the three combinations of coatings at their respective concentration limits as assessed by the SCCS are allowed for use with titanium dioxide (nano) as a UV-filter, subject to the other conditions listed in entry 27a of Annex VI to Regulation 1223/2009.
However, the SCCS warned that there is a potential risk to human health arising from the ingestion of manganese dioxide. Therefore, the combination of coatings alumina and manganese dioxide should not be allowed for use in lip products, as they are ingested to some extent.
Moreover, consumers may also apply some face products, such as sunscreens intended for application on the face, on the lips under reasonably foreseeable conditions of use. The application of face products on the lips leads to ingestion of the product to some extent.
Therefore, Hong Kong sellers of face products containing the combination of coatings alumina and manganese dioxide should be aware that the product concerned will henceforth have to bear a warning against the use of these products on the lips in order to be compliant with the EU legislation.
Commission Regulation (EU) 2019/1858 was also published on 7 November 2019, and amends Annex V to Regulation 1223/2009 on cosmetic products. Annex V is a list of “Preservatives Allowed in Cosmetic Products” throughout the EU. The new Commission Regulation thus concerns the substance 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one (CAS Number 569646-79-3), which has been assigned the name Hydroxyethoxyphenyl Butanone (HEPB) under the International Nomenclature of Cosmetic Ingredients and has the function of preservative and skin conditioning.
The SCCS had previously already concluded in its opinion of 7 April 2017 that HEPB can be considered safe when used as a preservative in rinse-off, oral care and leave-on cosmetic products at a maximum concentration of 0.7%. However, at the time, SCCS had also concluded that more evidence was necessary to exclude eye irritation.
To this end, following concerns raised by several Member States on HEPB as a potential eye irritant and additional scientific data submitted, the SCCS concluded in its opinion of 5 March 2019 that, under an aggregate exposure scenario, the use of HEPB as a preservative in rinse-off, oral care and leave-on cosmetic products at a maximum concentration of 0.7 % is safe with regard to eye irritation.
In light of the SCCS opinion and in order to take into account technical and scientific progress, the use of HEPB will henceforth be allowed for use as a preservative in rinse-off, oral care and leave-on cosmetic products at a maximum concentration of 0.7% in ready for use preparations.
Hong Kong sellers of cosmetic products containing the substances mentioned above should bear in mind that the new Regulations both entered into force on 27 November 2019, which is 20 days from the date of their publication.