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Placing toys onto European Union (EU) markets requires the navigation of a variety of requirements relating to the restriction of hazardous substances.

In September Dr. Tsang, SGS Global Information and Innovation Manager, will present two webinars to help stakeholders understand their obligations regarding chemicals and accessing European markets.

The safety criteria that toys must comply with before they are allowed onto EU markets are laid down in Directive 2009/48/EC, the so-called European Toy Safety Directive (TSD). Replacing Directive 88/378/EEC, the TSD has far tighter restrictions on the use of certain hazardous chemicals. In addition, manufacturers and suppliers must be aware of Regulation (EC) 1272/2008 – Classification, labeling and Packaging of Substances and Mixtures (CLP Regulation) and REACH – Registration, Evaluation, Authorization and Restriction of Chemicals.

In this article and forthcoming webinars we will consider how stakeholders can navigate these regulations and, in especial, we will look at phthalates and the European EN 71-3 standard, ‘Migration of Certain Elements’.

Phthalates

A ubiquitous family of inexpensive synthetic chemical additives, phthalates are mainly used as a plasticizer in polymeric and rubber materials in a diverse range of consumer goods, including toys and juvenile products, DIY, tools and hardware, food contact materials and articles, home furnishings and houseware, sports and leisure equipment, stationery and office supplies, clothing, footwear, leather products, home textiles, jewelry, bags and accessories, cosmetics and personal care products, and electrical and electronic equipment (EEE).

CLP Regulation lists many phthalates as reprotoxic category 1B substances. Inclusion in these lists increases the number of restrictions that are placed on their use in the manufacture of consumer goods.  

In December 2018, the European Union amended REACH by replacing Entry 51 in Annex XVII. The new Entry 51 increases the number of phthalates restricted from use in toys and childcare articles from three to four. The restricted phthalates are:

  • Bis(2-ethylhexyl) phthalate (also known as di(2-ethylhexy) phthalate, DEHP)
  • Dibultyl phthalate (DBP)
  • Benzyl butyl phthalate (BBP)
  • Diisobutyl phthalate (DIBP)

The new version of Entry 51 has also expanded the range of products covered to include ‘articles’.

The placing on the market of any product covered by the enhanced scope of Entry 51 is restricted from July 7, 2020.

EN 71-3:2019

EN 71-3 – ‘Migration of Certain Elements’ – is the most important chemical standard in the EN 71 series of toy safety standards. Prepared by Technical Committee CEN/TC 52 ‘Safety of Toys’, it specifies the requirements and test methods for the migration of 19 elements, including two types of tin and chromium, from toy materials and parts of toys.

First published by the European Committee for Standardization (Comité Européen de Normalisation, CEN) in 2013, it was cited in the Official Journal of the European Union (OJEU) as demonstrating presumption of conformity with the TSD.

Since 2013, EN 71-3 has been amended several times, in part to accommodate strengthened migration limits for barium, cadmium and lead. The latest version, EN 71-3:2019, was published in April 2019. This voluntary standard contains procedures for the selection of test portions, sample preparation of different toy materials, extraction of 19 restricted soluble elements by mimicking toy materials in biological systems for a period of time after ingestion, and the use of three different methods for the determination of chromium (VI), organic tin, and other general elements. As part of its improvement to the methodology, the standard also adapts the strengthened migration limit for chromium (VI) falling under category III toy materials.

The EN 71-3:2019 standard will be given the status of a national standard by October 2019 and is expected to be harmonized under the TSD upon official acceptance by the European Commission (EC) and by publication in the OJEU.

SGS Assistance

We are pleased to announce two complimentary webinars covering the above two topics as part of our commitment to providing information about developments in regulations and standards for consumer products.  

Webinar on September 5, 2019

Title: Phthalate Regulations: Accessing the EU and North American Markets
Time: 10:00 am Paris time (45 mins with Q&A)
Speaker: Hing Wo Tsang
Registration: Register now

Webinar on September 19, 2019

Title: Phthalate Regulations: Accessing the EU and North American Markets
Time: 10:00 am NY time (45 mins with Q&A)
Speaker: Hsin Chen
Registration: Register now

Webinar on September 26, 2019

Title: Chemical Safety in Toys Entering the EU Market
Time: 10:00 am Paris time (45 mins with Q&A)
Speaker: Hing Wo Tsang
Registration: Register now

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For more information, please contact:

Stephanie Meyer-Pionchon
Global Marketing Manager
t: +33 6 31 25 17 97
www.sgs.com/hardlines

Updated: September 6, 2019