The sale of pacifiers and bottle teats that release more than 10 micrograms of N-nitrosamines or more than 100 micrograms of nitrosatable substances per kilogram of rubber or silicone is prohibited.
Regulations aimed at protecting infants The regulations are intended to prevent infants from being exposed to dangerous substances when using a pacifier or teat. Rubber and silicone can form nitrosamines or nitrosatable substances upon contact with saliva. Most of these substances can be carcinogenic.
Labelling and packaging The producer, importer or distributor must provide the following information on the pacifier or teat packaging:
This information must be printed with clear, legible and indelible print. Producers and importers are responsible
Anyone who produces or imports pacifiers or bottle teats for infants is responsible for ensuring compliance with the regulations, as set out in the statutory order.
The Environmental Protection Agency’s chemical inspectors monitor compliance with the regulations and will ensure that illegal situations are brought into compliance. This may involve withdrawing the product from the Danish market, or making the product legal in some other way. Anyone who breaches the regulations may additionally face a fine or prison sentence of up to four months.
More information The entire text of the statutory order is available (in Danish) on the Retsinfo website: Ministry of the Environment Statutory Order no. 51 of 10 February 1986 on pacifiers and bottle teats, with later amendments
National REACH helpdesk is a service established in every Member State providing advice to companies and other stakeholders on the obligations they may have under REACH.
The Danish REACH helpdesk:www.reachhelpdesk.dk (in Danish) Ph: + 45 7012 0211
Read more about REACH and national helpdesks atThe European Chemicals Agency