Filed under: EU Regulation/Legislation, REACH/CLP, Toys | Tags: lead, REACH, regulation
The European Commission has adopted a new restriction under the REACH Regulation which covers lead in consumer items which “during normal or reasonably foreseeable conditions of use, be placed in the mouth by children.”
The Regulation, 2015/628, restricts the placing on the market of consumer items containing 0.05 % lead, by weight, overall or in those parts accessible to children unless it can be demonstrated that the rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0.05 μg/cm2 per hour (equivalent to 0.05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article.
Enforcement of this Regulation depends upon the more subjective assessment of whether normal conditions of use would endanger children by the placing of the items in the mouth, as well as the more objective measurement of the lead content, which should not prove a significant issue for any competent laboratory accredited for such tests.
Filed under: EU Information, Toxicology, Toys | Tags: chromium (VI), regulation, Toys
The European Commission’s Scientific Committee on Health and Environmental Risks (SCHER) has proposed that the levels of Chromium (VI) available by migration from toys be further lowered.
The proposed values are:
- 0.0094 mg/kg for scraped-off toy materials;
- 0.0008 mg/kg for dry, (powder-like or pliable) toy materials; and
- 0.0002 mg/kg for liquid or sticky toy materials
These values are extremely low, and are in fact below the levels at which chromium (VI) can be measured in the laboratory. Chromium (VI) is a very difficult species to measure, and it is only in recent years that methods capable of separating the more toxic hexavalent form from the more common trivalent form have been developed.
There is a school of thought that instituting a limit value below that which can be measured should not happen and that it would be more sensible to have a limit value equivalent to the best available limit of quantification (LOQ), which can of course be lowered as advances in measurement capability develop.
The International Standards Organisation, ISO, have published a new standard, ISO 8124-6, which lays down methods of analysis for the determination of six toxic phthalate plasticisers in toys. The phthalates concerned are:
- di-n-butyl phthalate (DBP);
- benzyl butyl phthalate (BBP);
- bis-(2-ethylhexyl) phthalate (DEHP);
- di-n-octyl phthalate (DNOP);
- di-iso-nonyl phthalate (DINP); and
- di-iso-decyl phthalate (DIDP).
The work on developing the standard was led by the Standardisation Administration of China (SAC).
It is important that internationally-agreed methods of analysis for these compounds are available to help trade and enforce regulations such as REACH.
Filed under: ECHA, REACH/CLP, Toys | Tags: CLP; REACH; Chemicals; ECHA, REACH, Toys
ECHA, the European Chemicals Agency, has compiled more detailed guidance on the restriction on the use of phthalates in toys and childcare products under Annex XVII of REACH, in the form of a Q&A article.
The most relevant section of this article concerns the “concentration limit of 0.1 % by weight of the plasticised material in toys and childcare articles.” This should be interpreted as “the concentration limit of the 3 phthalates mentioned is to be calculated taking into account all the plasticised material contained in the entire article which is being placed on the market. In the specific example of a doll, the concentration of phthalates should be calculated on the basis of the total weight of the plasticised material of the whole doll and not only on the plasticised material of the head.”
Therefore, laboratories measuring the concentrations of the 3 phthalates (DEHP, DBP, BBP) need to ensure that they take samples for analysis from toys and childcare articles appropriately to avoid obtaining a false result.
Filed under: EU Information, EU Regulation/Legislation, Toys | Tags: chromium, testing, Toys
The European Commission has launched a consultation regarding the levels of chromium (VI) in toys, following publication of a preliminary opinion from the Commission’s Scientific Committee on Health and Environmental Risks (Scher) about the safe limits of this toxic form of chromium in toys, taking into account many factors which add risk to products.
The preliminary opinion has considered that the current limits for chromium (VI) in toys should be revised downwards to 0.0094 mg/kg for scraped-off materials (previously 0.2), 0.0008 mg/kg for dry, powder-like or pliable materials (0.02) and 0.0002 mg/kg for liquids or sticky materials (0.005).
If these limits are revised downwards, it is important that analytical measurements can be accurately and precisely made at these very low levels. Methods have been developed which are able to measure chromium (VI) at the current levels; further development would be needed in order to measure accurately at the proposed levels which are approximately 2 orders of magnitude lower.
Work funded under the Government Chemist Programme advisory function on determining chromium (VI) at very low levels in water using HPLC-ICP-MS has demonstrated that it is possible to achieve both accuracy and precision at levels of 0.02 µg/L (equivalent to 0.00002 mg/kg). To further develop this approach for toys would therefore depend on validating a suitable extraction process which maintains the integrity of chromium in its +6 oxidation state (which is not a trivial undertaking) whilst ensuring any resulting solution contains chromium (VI) at an appropriate concentration for measurement.
Filed under: EU Regulation/Legislation, Toys, Uncategorized | Tags: endocrine disrupters, Toys
The European Commission has announced that the permitted levels of bisphenol A in toys is reduced to 1 mg/L (migration limit). This covers toys which are intended to be placed in a child’s mouth.
Bisphenol A is strongly suspected of being an endocrine disrupting chemical (EDC). This reduction places increased responsibility on analytical measurement laboratories to be able to detect and quantify accurately bisphenol A in toys in order to assist in effective enforcement.
The European Standards Organisation, CEN, has published a new version of EN standard on Safety of toys – EN 71 Part 7: Finger paints – Requirements and test methods.
This new version (EN 71-7:2014) brings the requirements for finger paints up to date with respect to the EU Toy Safety Directive and the requirements of the REACH Regulations.
Specific changes of interest include a revised limit value for the carcinogenic polynuclear aromatic hydrocarbon (PAH) benzo[a]-pyrene, which is set at the limit of quantitation of the analytical method used, 0.02 mg/kg. This is a welcome development, where the limits in the standard are in line with what can be achieved with the state-of-the-art of analytical measurement capability. We highlighted last year the restrictions under REACH for PAHs in toys, and this new standard recognises that development. The addition of limit values for polychlorinated biphenyls (PCBs) is another welcome development, and a valid measurement method for PCBs is included in the standard.