SAFEGUARDS | Toys & Juvenile Products NO. 133/16

SafeGuardS kids playing dough

In light of new scientific data, the EU is proposing to strengthen the migration limit for Bisphenol A (BPA) under the Toy Safety Directive 2009/48/EC (TSD). The proposed effective date is Q2 2018.

In June 2014, we [1] informed you that the European Union (EU) published Directive 2014/81/EU to restrict bisphenol A (BPA, CAS 80-05-7) in toys for children under 36 months, or other toys intended to be placed in the mouth. This was an amendment to Appendix C of Annex II of the Toy Safety Directive 2009/48/EC (TSD), and the restriction came into effect in December 2015.

On July 18, 2016, the World Trade Organization (WTO) circulated a notification announcing a draft Directive from the EU to strengthen the migration limit for BPA from 0.1 mg/L to 0.04 mg/L. It is proposed that this draft Directive is adopted in Q4 2016 and the provision to strengthen BPA migration Q2 2018.

According to the draft Directive, attached to WTO document number 16-3856 [2], the revised limit for BPA would be consistent with the latest scientific data and refined methodologies. It is interesting to note that the basic considerations for deriving the migration limit for BPA in toys are different to those for the migration of BPA in food contact plastics [3] and the prohibition of BPA in polycarbonate infant feeding bottles. [4]

In early 2016, the WTO also circulated two notifications from the EU to regulate BPA in certain consumer products.  These are:

  1. To restrict BPA in thermal receipt paper under Annex XVII of REACH [5]

  2. To strengthen the migration limit of BPA in food contact plastics by 12-fold. [6] The scope of this draft Regulation also covers varnished or coated materials and articles

Highlights of BPA migration under the proposed Directive for toy safety, and its comparison with Directive 2014/81/EU, are summarized in Table 1.

Table 1: BPA Migration under Appendix C to Annex II of Directive 2009/48/EC

Citation Directive 2014/81/EU Proposed Directive under WTO Document No.16-3856
  • Toys for children under 36 months
  • Other toys intended to be placed in the mouth
Method EN 71 Parts 10-11
Requirement ≤ 0.1 mg/L ≤ 0.04 mg/L
Effective date December 2015 Q2 2018

SGS offers a wide range of services to ensure that your products comply with the EU Toy Safety Directive. We offer training, safety/risk assessment, technical documentation check, labelling review, testing according to harmonised standards, SVHC screening, inspections and audits. With the largest global network of toy experts and testing facilities around the world - around 20 toy labs worldwide including 3 EU Notified Bodies (France, Germany and Netherlands), SGS is the partner to trust. Please do not hesitate to contact us for further information or visit our website.

For enquiries, please contact:

Hing Wo Tsang
t: +852 2774 7420

Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!

© SGS Group Management SA - 2016 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.