SGS Summarizes EU Regulations on Chemicals in Juvenile Products

Are you 100% sure that the juvenile products you design for, or sell on, the European market are free from hazardous chemicals?

Chemical Regulations to Ensure Safe Juvenile Products

Babies and young children explore the world in many ways. When they come into contact with juvenile products, they will often put them into their mouths; licking and/or chewing the accessible parts of products, such as textiles, plastics, even the timber of exposed bed frames. To sell safe products, they must conform to EU-wide and member state regulations and requirements relating to chemicals, including:

- General Product Safety Directive (GPSD), including: EN 71-3: Migration of Certain Elements

- REACH (SVHCs and Annex XVII)

- Persistent Organic Pollutants (POPs)

- Food contact materials

- Bisphenol A (BPA)

- Member state legislation/standards

It is important to understand which requirements and regulations need to be taken into account to avoid costly mistakes.

The EU General Product Safety Directive

The GPSD is an umbrella Directive that ensures a high level of product safety throughout the EU for consumer products that do not have sector specific legislation. In this context, it applies to childcare articles and juvenile products. Conformity can be achieved by demonstrating compliance with the GPSD’s harmonized EN standards. These EN standards are essentially safety standards, including chemical safety, for a wide range of juvenile products not covered by national rules.

The application of EN 71-3 (Migration of Certain Elements) is different and is dependent on the standard for juvenile products:

1. Standards which clearly apply limits of EN 71-3:1994

- EN 1888: 2012 – Wheeled child conveyances

- EN 1272: 1998 – Table mounted seats

- EN 12586 +A1: 2011 – Soother holders

- EN 16120: 2012 – Chair mounted seats

- EN 16120 +A1: 2014 – Table mounted seats

- EN 16232: 2013 – Infant swings

2. Standards in which reference to EN 71-3 is not dated but request limits of EN 71-3:1994

- EN 12227: 2010 – Playpens

- EN 12221-1 +A1: 2013 – Changing units

- EN 1930: 2011 – Safety barriers

- EN 1273: 2005 – Baby walking frames

- EN 12790: 2009 – Reclined cradles

- EN 13209-1: 2004 – Framed baby carriers

- EN 13209-2: 2005 – Soft baby carriers

- EN 13210: 2004 – Harnesses and reins

- EN 14036: 2003 – Baby bouncers

3. Standards in which reference to EN 71-3 is not dated and implying application of 2013 requirements (including any amendments)

- EN 716-1 +A1: 2013 – Cots and folding cots for children

- EN 1130: 1996 – Cribs and cradles

- EN 14988-1 +A1: 2012 – High chairs

- EN 14344: 2004 – Bicycle seats for children

- EN 1466: 2014 – Carry cots and stands

Juvenile products are subject to the GPSD when they are not subject to any specific European or member state legislation.

REACH Regulation – A Framework for Chemical Use

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation provides a high level of protection to human health and the environment from chemical use. It places responsibility for understanding and managing the risks posed by chemicals in products on manufacturers and importers, including substances of very high concern (SVHCs) and prohibited or restricted substances.

- SVHCs are hazardous substances with serious consequences. They can cause cancer and have other harmful properties. They can also remain in the environment for a long time. Their quantities gradually build up in animals. An EU manufacturer and EU importer of articles containing any SVHC, as per the Candidate List, at a concentration > 0.1% w/w, shall provide the recipient with sufficient information to allow the safe use of the article (communicate information along the supply chain).

- Prohibited and restricted substances are listed in Annex XVII of REACH. Of all the products listed, the juvenile products industry needs to be aware that the substances, among others, cadmium, phthalates, nickel, azo dyes, PAHs and dimethyl fumarate (DMFu) are all listed as prohibited and/or restricted.

Persistent Organic Pollutants in Juvenile Products

A global treaty under the Stockholm Convention in 2001 and across the EU under Regulation (EC) 850/2004 defines POPs (http://www.sgs.com/en/White-Paper-Library/Proliferation-Regulation-and-Mitigation-of-Persistent-Organic-Pollutants.aspx) as toxic chemicals that adversely affect human health and damage the environment. Their danger lies in their ability to be transported by wind and water and to persist in the environment for long periods of time. They include flame retardants, pesticides, PFOSs and SCCPs.

EU Legislation on Food Contact Materials

The Food Contact Materials & Articles Regulation (EC) 1935/2004 states that any material intended to come into direct contact with food must be sufficiently inert to preclude substances from being transferred to food in quantities which could endanger human health, bring about unacceptable changes to the composition of the food, or cause the organoleptic properties to deteriorate.

For child care articles made of plastics, the Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food – commonly referred to as the Plastics Implementing Measure (PIM) – applies. Beginning 1 January 2016, compliance documents should be based on migration testing using food simulants and test conditions established in the PIM.

In many EU member states, additional national food contact legislation applies for aspects not already harmonized.

Other Applicable Juvenile Product Safety Standards

Across the EU, there is a number of EU-wide and member state specific standards that should also apply to juvenile products. For instance, Germany published new specifications for polycyclic aromatic hydrocarbons (PAHs) (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-18714-germany-amends-pah-specifications-gs-mark-a4-en-14.pdf) under the voluntary GS-Mark which will take effect on 1 July 2015. PAH restriction under REACH Annex XVII entry 50 includes juvenile products. An expert understanding of the destination market can identify any additional regulations and requirements that must be met.

About SGS Safety Solutions for Juvenile Products

SGS has an international team of professional experts with a comprehensive knowledge of safety for juvenile products for the European market. The company’s global network delivers consistent and coherent testing, certification (http://www.sgs.com/en/Consumer-Goods-Retail/Toys-and-Juvenile-Products/Juvenile-Products-and-Childcare-Articles/Audits-and-Certification.aspx) and verification services to expedite products’ route to market.

For further details contact an SGS local sales representative or the global team.

Contact details:

SGS Consumer Testing Services

Catherine Follin-Arbelet
Senior Expert, Juvenile Products
SGS CTS France
t: +33 4 42 61 64 57

HingWo Tsang, Ph.D.
CTS Toys and Juvenile Products
Information and Innovation Manager
SGS Hong Kong Limited

t: +852 2774 7420
Email: [email protected]
Website: www.sgs.com/juvenileproducts