EU Chemical Regulations for Juvenile Products
Are you 100% sure that the juvenile products you design for, or sell on, the European market are free from hazardous chemicals?
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 mouth; 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.
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 harmonised 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 (see Table 1).
Juvenile products are subject to the GPSD when they are not subject to any specific European or member state legislation.
The Registration, Evaluation, Authorisation 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
A global treaty under the Stockholm Convention in 2001, and across the EU under Regulation (EC) 850/2004, define POPs 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.
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 harmonised.
Other Applicable Standards
Across the EU, there are 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) under the voluntary GS-Mark which will take effect on 1 July 2015. PAH restriction under REACH Annex XVII entry 50 includes juvenile products. Expert understanding of the destination market can identify any additional regulations and requirements that must be met.
SGS has an international team of professional experts with a comprehensive knowledge of safety for juvenile products for the European market. Our global network delivers consistent and coherent testing, certification and verification services to speed your products’ route to market.
For further details, visit SGS Juvenile Products, contact your local sales representative, or our global team at:
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
Table 1. EN 71-3 Application Rules
CLEARLY APPLY LIMITS
OF EN 71-3: 1994
|STANDARDS IN WHICH
REFERENCE TO EN 71-3
IS NOT DATED BUT
REQUEST LIMITS OF
EN 71-3: 1994
|STANDARDS IN WHICH
REFERENCE TO EN 71-3
IS NOT DATED AND IMPLYING
APPLICATION OF 2013
EN 1888: 2012 – Wheeled child conveyances
|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
|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