COMMISSION DECISION
of 6 January 2010
on the safety requirements to be met by European standards for bath rings, bathing aids and bath tubs and stands for infants and young children pursuant to Directive 2001/95/EC of the European Parliament and of the Council
(notified under document C(2009) 10290)
(Text with EEA relevance)
(2010/9/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (1), and in particular Article 4(1)(a) thereof,
Whereas:
(1)
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.
(2)
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 conforms to voluntary national standards transposing European standards.
(3)
In 2006 the Commission commissioned a study (2) to assess the safety of several child-care articles which are commonly used for the care of infants and young children from 0 until 5 years of age, in cooperation with national authorities, national standardisation bodies, consumer associations, product safety organisations, economic operators and testing laboratories.
(4)
For these products, the study collected relevant statistics on accidents and injuries in the EU and worldwide and carried out a complete risk assessment, based on identification of the main hazards and assessment of exposure scenarios.
(5)
Bath rings, bathing aids and bath tubs, whether or not combined with stands, are amongst the products assessed by the study. These products are used to bath babies and young children and have been identified as posing serious risks, mainly of drowning accidents which have often resulted in fatalities, due to the young age of the users.
(6)
Evidence and statistics gathered from accidents consistently show that the risk of drowning is due to insufficient, inconclusive and inconspicuous warnings and instructions on the safe use of products and to their poor structural integrity and resistance. Accidents and statistics have also revealed risks of falling, injury and ingestion of small parts associated with the use of these products and inadequate supervision on the part of the carer.
(7)
Although there is extensive information worldwide on bath-drowning accidents and injuries in early childhood, a direct correlation between the use of bath-assisting devices and fatalities or accidents in the bath is unconfirmed. Researchers and scientific literature worldwide concur that there is no decisive evidence demonstrating a link between the increase in the number of accidents and the use of bath-assisting devices (3). Some researchers, observing latest trends of the increase in the sales of bath rings and the decrease in bath-related accidents and drowning, have even claimed a ‘small protective effect’ due the use of bath rings (4).
(8)
No European standards exist for these three types of products. It is therefore necessary to determine specific requirements under Article 4(1)(a) of Directive 2001/95/EC, with the view to requesting the standardisation bodies to develop standards to reduce the risks associated with the use of bath rings, bath aids and bath tubs (whether or not combined with stands) while bathing babies or young children. These standards should be developed according to the procedure laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (5). The reference of the standard adopted should be published in the Official Journal of the European Union, in accordance with Article 4(2) of Directive 2001/95/EC.
(9)
Once the relevant standards are available, and provided that the Commission decides to publish their reference in the Official Journal, according to the procedure laid down in Article 4(2) of Directive 2001/95/EC, bath rings, bathing aids and bath tubs (whether or not combined with stands) manufactured in compliance with such standards should be presumed to conform to the general safety requirement of Directive 2001/95/EC, as far as the safety requirements covered by the standards are concerned.
(10)
To improve the current safety levels while using these products, it is necessary to both take action on standards and provide parents and adult caregivers with information on the purpose and safe use of these products.
(11)
The measures provided for in this Decision are in accordance with the opinion of the Committee set up under Article 15 of Directive 2001/95/EC,
HAS ADOPTED THIS DECISION:
Article 1
Definitions
For the purposes of this Decision:
-
‘bath rings for babies’ (‘bath seat’) means products allowing to keep a child in a seated position during bathing. These products are intended for use only with a child who is able to sit upright unassisted and should not be used when the child begins pulling up to a standing position.
-
‘bathing aids for babies’ means products allowing to keep a child in a reclined or lying position during bathing. These products are intended for use from birth and until the child is able to sit upright unassisted.
-
‘bath tubs for babies and young children’ means products designed for bathing children from birth up to 12 months. These products can be used as stand-alone products, placed in or on the rim of a regular bathtub or on the floor, or combined with stands.
Article 2
Requirements
The specific safety requirements for the products referred to in Article 1 to be met by European standards pursuant to Article 4 of Directive 2001/95/EC shall be set out in the Annex to this Decision.
Article 3
Publication
This Decision shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Done at Brussels, 6 January 2010.