26 REGULATIONS Commission
Regulation (EU) 2018/35 Commission Regulation (EU) 2018/35 is an amendment to the Regulation (EC) No 1907/2006 (REACH). It restricts the use of cyclotetrasiloxane and cyclopentasiloxane to a maximum concentration of 0.1% by weight in rinse-off products on environmental grounds. Cyclotetrasiloxane is considered to be a persistent, bioaccumulative and toxic (PBT) substance and a very persistent very bioaccumulative (vPvB) substance and cyclopentasiloxane is considered to be a very persistent very bioaccumulative (vPvB) substance. The 0.1% maximum concentration does not apply to leave–on products that are in prolonged contact with the skin, hair or mucous membranes as cyclotetrasiloxane and cyclopentasiloxane are able to evaporate over time and any residues washed off are not considered to be a major risk to the environment. Rinse-off cosmetic products containing 0.1% by weight or greater of cyclotetrasiloxane or cyclopentasiloxane must not be placed on the European Union market after 31 January 2020.
The Scientific Committee on Consumer Safety opinion for cyclopentasiloxane (SCCS/1549/15) should also be considered for products containing cyclotetrasiloxane and cyclopentasiloxane. Cyclotetrasiloxane is an impurity found in cyclopentasiloxane and is classified as toxic to reproduction category 2 by Regulation (EC) No 1272/2008. The Scientific Committee on Consumer Safety concluded that the level of cyclotetrasiloxane impurity in cyclopentasiloxane should be kept to as low as possible. The Scientific Committee on Consumer Safety opinion did not cover the use of cyclopentasiloxane in oral care products or its effect on the environment.
SCCS Opinions 2018
The next part of this article summarises the final opinions on the safety of ingredients published by the Scientific Committee on Consumer Safety in 2018. The opinions of the Scientific Committee on Consumer Safety are a good indicator of how Regulation (EC) No 1223/2009 will be amended in the future.
SCCS/1583/17 – Titanium Dioxide (nano form)
The Scientific Committee on Consumer Safety were asked to consider if titanium
PERSONAL CARE EUROPE dioxide (nano) is
safe when used as a UV filter in sunscreens and personal care products at a maximum concentration of 5.5%. The committee concluded that the information submitted was insufficient for them to assess the safety of nano-titanium dioxide in spray applications which may be inhaled in to the lungs. The Scientific Committee on Consumer Safety noted in the opinion that there are already sprayable products on the market which contain nano-titanium dioxide and that these products should be carefully evaluated so that the chance of harmful effects to the lungs through inhalation is avoided.
SCCS/1586/17 – Water soluble zinc salts used in oral hygiene Water soluble zinc salts including zinc acetate and zinc chloride but excluding zinc 4- hydroxy-benzene sulphonate and zinc pyrithione are permitted in cosmetic products up to a maximum concentration of 1% as zinc (annex III, entry 24). In July 2014 the German authority, Federal Institute for Risk Assessment (BfR) expressed concern about the safety of using zinc salts at 1% (as zinc) in oral products such as toothpaste and mouthwash and proposed a lower maximum concentration of 0.1% (as zinc) for hygiene products used by adults and that zinc should not be present in products used by children and young people under the age of 18 years. Cosmetics Europe, the European trade body, has calculated that an aggregate exposure for zinc from food sources as well as oral care product supports the safe use of soluble zinc salts at a maximum concentration of 1.0% (as zinc) for all age groups. For mouthwashes, Cosmetics Europe supports the use of water soluble zinc salts at maximum concentration of 0.1% (as zinc).
In opinion SCCS/1586/17 the Scientific Committee on Consumer Safety concluded that the use of soluble zinc salts in toothpaste and mouthwash at a maximum concentration of 1% (as zinc) is safe for adults and children of 6 years and older. They concluded that the use of water soluble zinc salts at a concentration of 1% (as zinc) in toothpaste is safe for children aged 0.5 - 5 years.
SCCS/1592/17 – HEMA and Di-HEMA Trimethylhexyl Dicarbamate The Scientific Committee on Consumer Safety looked at the safety of HEMA and Di-HEMA trimethylhexyl dicarbamate in UV- cured artificial nail modelling systems. The Scientific Committee on Consumer Safety concluded that the use of HEMA and di- HEMA- trimethylhexyl dicarbamate at concentrations of up to 35% and 99% respectively are not likely to present a risk of sensitisation providing that their use is restricted to the nail plate. However the Scientific Committee on Consumer Safety raised concerns that sensitisation may occur from the monomers coming into contact with the skin adjacent to the nail plate. They also expressed concerns that sensitisation may be possible from impurities and degradation products in the two methacrylate monomers. In professional settings, removal of previous applications of these products by filing or sanding may expose professionals to respiratory exposure to particulate dust if appropriate protective measures are not used. The Scientific Committee on Consumer Safety concluded that the potential for sensitisation to methacrylate monomers is likely to be higher for professionals who do not routinely use appropriate protective measures.
SCCS/1593/18 – Zinc Pyrithione Zinc pyrithione is permitted to be used as a preservative in cosmetic products at a maximum concentration of 1.0% in rinse-off hair products and 0.5% in other rinse–off products (annex V, entry 8). It is not permitted to be used in oral products. It can be used up to a maximum concentration of 0.1% in leave–on hair products providing its use is not for inhibiting the development of micro- organisms in the product.1
SCCS/1593/18 is an addendum to the scientific opinion on zinc pyrithione (SCCS/1512/13). In opinion SCCS/1512/13 the Scientific Committee on Consumer Safety concluded that zinc pyrithione was safe to use at a maximum concentration of 2% as an anti-dandruff agent in rinse–off hair products. The Scientific Committee on Consumer Safety in opinion SCCS/1593/18 considered new data on fertility and developmental toxicity and concluded that zinc pyrithione was still safe to use at a maximum concentration of 2.0% as an anti- dandruff agent in rinse-off hair products. The Swedish Chemicals Agency submitted a harmonised classification and labelling (CLH) dossier to the European Chemicals Agency (ECHA) in October 2016 to support a harmonised classification of toxic to reproduction category 1B and specific target organ toxicity – repeated exposure category 1 (STOT RE 1). If this
April 2019
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