Directorate-General for Health and Food Safety
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When preparing proposals related to consumer safety, health and the environment, the European Commission relies on independent Scientific Committees to assess the potential risks.
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TCEP IN TOYS
Are there risks when the flame retardant TCEP (tris(2-chloroethyl)phosphate) or its halogenated alternatives are present in toys at concentrations lower than those set up under current legislation? If there are risks, should there be a limit for TCEP? Are the risks for children under the age of 3, who very frequently mouth toys (and other objects), different from those for children over 3 years old?
PIGMENT RED 57
USED IN HAIR DYES
Pigment Red 57 is a colouring product used in non-oxidative hair dye, with a common maximum on-head concentration of 0.4%. Taking into account the scientific data provided, is the use of this product safe for consumers?
Studies in rats and mice provide clear evidence that TCEP is carcinogenic and shows reproductive toxicity, with a threshold dose below which effects are no more evidenced. Based on the available data, TCEP is a suspected human carcinogen and a presumed human reproductive toxicant.
Exposure to TCEP can occur through:
Considering all ways of exposure (except toys), 1- to 3-year old children are exposed to around 13 microgram TCEP per kg bodyweight per day.
The provisional tolerable daily intake, calculated using a conservative approach, is 13 microgram per kg bodyweight per day.
The estimated daily exposure for children is similar to the tolerable daily intake. In light of uncertainties in the data on the effects of and the exposure to TCEP, the Scientific Committee considered that the estimated margins of exposure may not adequately protect human health.
The Scientific Committee on Consumer Safety considers that the available data do not indicate that Pigment Red 57 is toxic: at the low systemic exposure level in hair dye, it is not easily absorbed into the scalp. However, Pigment Red 57 is also used in other cosmetic products as a colourant, which could lead to higher accumulated exposure for consumers who use several of these cosmetic products.
TCEP from toys will likely add to TCEP from other sources. Therefore the Scientific Committee concluded in its Opinion that no additional exposure from toys can be considered safe. The use of TCEP should be avoided in toys for children both below and above 3 years of age. The limit for TCEP in toys should be set at the detection limit of a sufficiently sensitive analytical test method.
The Scientific Committee on Consumer Safety sees no safety concern for consumers from the use of Pigment Red 57 in non-oxidative hair dye formulations at a maximum on-head concentration of 0.4%. Therefore, the Scientific Committee concludes that Pigment Red 57 does not pose a risk to the health of the consumer.
According to the precautionary principle, if a given policy or action might cause harm to the public or the environment and if there is still no scientific consensus on the issue, the policy or action in question should not be pursued. Once more scientific information becomes available, the situation should be reviewed. Under the proportionality rule, the action of the EU must be limited to what is necessary to achieve the objectives.
Commission Directive 2014/79/EU sets new stricter limit values for TCEP in toys for children under 3 years old and in other toys intended to be placed in the mouth.
Commission Regulation (EU) 2015/1190 of 20 July 2015 has amended Annex III of the Cosmetic Regulation (EC) 1223/2009 by adding Pigment Red 57 with entry 296 laying down the specific conditions of use for this hair dye ingredient in line with the SCCS Opinion SCCS/1411/11.