Updated BfR opinion No. 010/2012, 11 April 2012, is a one-page English summary. The full German opinion is cited by URL and is not in this file. The summary is about nickel release from metal toys and about fragrance allergens in toys. It does not report a measured nickel concentration.
Key numbers
About 10 percent of children are sensitised to nickel, and roughly 2 percent to fragrances. Those shares are stated in the summary. They are not a new prevalence study.
The summary says the REACH regulation limits nickel release from products with direct and prolonged skin contact, and that the Toy Directive does not itself set a nickel-release threshold for toys in skin contact. It says the REACH limit should also apply to metal-alloy toys in intensive, extended skin contact, and that the Commission explanatory guidance says the REACH limit has to be applied to the corresponding toys. The numeric REACH release limit is not printed on this page, so it is not entered here.
For fragrances, the summary says 55 allergenic fragrances and fragrance ingredients are banned under the Toy Directive, 11 further fragrances must be declared, and trace amounts of the banned substances up to 100 mg per kg of toy material are permitted. BfR says 100 mg/kg is too high and that the banned fragrances should not be detectable. It recommends that the declaration threshold for the 11 fragrances fall from 100 mg/kg to 10 mg/kg. It also says toys for children under 3 years, and toys that can be put in the mouth, should contain no fragrances. The 10 mg/kg figure is that recommendation. It is not an enacted maximum level in this file.
The Federal Control Plan 2010 is cited for the statement that dermal nickel exposure from toys can be substantial. No nickel-release result from that plan is printed on this page.
Methods (brief)
This file is the English update only. No laboratory method is described in it.
Evidence fitness
The page supports what this summary says about nickel policy and about the fragrance thresholds it names. It does not support a nickel-release number, and it does not support a metal concentration in a toy.
Limitations
The German opinion was not read. A REACH release limit that is not printed here is not inferred. Preservatives in liquid and pasty toy materials are discussed in the summary and are not metal limits.
Related evidence
Update history
No substantive edit history is available in this build. The full commit record is available in git.