Decision 2010/376 - 2010/376/: Commission Decision of 2 July 2010 on the safety requirements to be met by European standards for certain products in the sleep environment of children pursuant to Directive 2001/95/EC - Main contents

EN

Official Journal of the European Union

L 170/39

Directive 2001/95/EC provides for European standards to be established by European standardisation bodies. These standards should ensure that products satisfy the general safety requirement of the Directive.

Under Directive 2001/95/EC a product is presumed safe, as far as the risks and risk categories covered by national standards are concerned, when it complies with voluntary national standards transposing European standards.

In 2006 the European Commission commissioned a study (2) to assess the safety of several child-care articles commonly used to care for babies and young children from 0 until 5 years of age. The study was carried out in cooperation with national authorities, national standardisation bodies, consumer associations, product safety organisations, economic operators and testing laboratories.

For these products, the study compiled statistics on accidents and injuries in the Union and worldwide and carried out a complete risk assessment, based on an identification of the main hazards and an assessment of exposure scenarios.

Five types of products assessed by the study, which are regularly found in the sleep environment of newborns and young children, were identified for follow-up to the study. These are cot mattresses, cot bumpers, suspended baby beds, children’s duvets and children’s sleep bags.

Every day, newborns sleep for on average at least 16 hours, and at 3-5 years children still sleep for 11-13 hours a day. Including awake periods, babies and young children spend at least half of the day in a sleep environment during their first five years of life. Products in the sleep environment must be safe, because that is where babies and young children are commonly left unattended for longer periods during the day and the night.

According to the European Injury Database IDB, between 2005 and 2007, 17 000 accidents involving children from 0 to 4 years happened in the cot in the European Union (3). According to the US Consumer Product Safety Commission (CPSC), every year more babies die in incidents involving cots and cot-related products than with any other child-care product (4).

Some models of cot bumpers and children’s sleep bags have been notified through the European rapid alert system RAPEX as posing risks of suffocation and choking and consequently withdrawn from the market or recalled. In 1992, the French Consumer Safety Commission recommended action to inform consumers and improve the safety of children’s duvets, due to risks of flammability, overheating and suffocation. (5) In 2002, 2007 and 2008 the US CPSC ordered the recall of some models of mattresses for cots due to entrapment hazards and unfounded claims (6).

Cot bumpers, mattresses, and children’s duvets, if unsafe or supplied without essential safety warnings, may increase the incidence of Sudden Infant Death Syndrome (SIDS) due to the risk of overheating and asphyxia (7).

At the same time, research has found that children’s sleep bags may have a protective effect against SIDS (8), since they reduce the incidence of turning to a prone position...