Migration of bisphenols from polycarbonate plastic in products CE-marked as toys
Level: Advanced. Also available as Core
The purpose of this requirement is to limit the migration of bisphenol A at the core level and to also limit the migration of bisphenols B and F at the advanced level. Bisphenols are suspected to be harmful to human reproductivity and are endocrine disrupting at low doses.
Details
- Type:
- Technical specification
- ID:
- 11018:2
- Group:
- Products CE-marked as toys
Criterion text
For products CE-marked as toys containing polycarbonate, migration of the bisphenols in the table below shall not exceed 0.04 mg/l.
Table of limited bisphenols and their CAS-number
| Substance | CAS-no |
|---|---|
| Bisphenol A | 80-05-7 |
| Bisphenol B | 77-40-7 |
| Bisphenol F | 2467-02-09 |
Exception:
- Parts of polycarbonate inaccessible to children or constituting less than 5 percent by weight of the product.
- Electronic toys.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- Valid license for any of for example the following labels:
- Nordic Swan Ecolabel for toys
- Technical documentation, for example material specification, showing which plastic type/types that are included in the toy.
- Technical documentation, for example an analysis report from an accredited laboratory that contains information verifying that the requirement is met. Analyses can be performed according to current versions of the standards SS-EN 71–10 and 71–11 or equivalent standard. For bisphenols B and F, LC-QTOF-MS can replace LC-DAD-FLD in EN 71-11.
- The supplier’s self-declaration including technical documentation of compliance verified by an accredited verification body, accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
Proposed follow-up
Labelling
If the requirement has been verified with a label, check that there is a valid license for the product in question. This can be checked: Nordic Swan Ecolabel
Material specification
If the requirement has been verified with a material specification, follow up the requirement by checking in the material specification which plastic type (s) that are included in the product. If there is more than five percent by weight of polycarbonate plastic in accessible parts of the product, the requirement is not met.
Analysis report
If the requirement has been verified with analysis reports, perform spot-checks on the analysis reports and check that the values are below the requirement limit value for each substance. Also check that the analyses were performed by an accredited laboratory.
Self-declaration verified by an accredited verification body
If a verified self-declaration is used to prove that the requirement is fulfilled, request the supplier’s self-declaration, including documentation showing that the requirement is met. The self-declaration shall be verified by a verification body accredited for the task in accordance with ISO / IEC 17029 or equivalent standard.
Information about the criterion
The requirement is only relevant for polycarbonate plastic products. Parts that are inaccessible to children mean that they are enclosed in the product.
This core requirement shall not be used in conjunction with the advanced requirement since the core requirement is included in the advanced requirement.
If you want to set requirements for the bisphenols B and F as well, the advanced requirement is used instead.
Electronic toys are excluded since some components,for example LEDs, may have polycarbonate covers or are covered with bisphenol A-based epoxy glue.
There are currently a limited number of accredited verification bodies for ISO/IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies) as it is a relatively new standard. This may change, especially if the demand for verifying compliance in this way increases. More information about the standard and accredited verification bodies can be found on Swedac's website.
Environmental goals
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11018:2
- Version date
- 2022-03-28