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Entry 51 and 52 of Annex XVII to REACH - Phthalates in toys and childcare articles
Entries 51 and 52 restrict the placing on the market and use of phthalates in toys and childcare articles. Does this restriction apply to medical devices, such as nebulisers?
Medical devices are defined in Article 2 of Regulation (EU) 2017/745 (see: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#current_legislation). Entries 51 and 52 pose restrictions on certain phthalates in plasticised materials in toys and childcare articles. Medical devices are generally regarded to have functions different from those of toys and childcare articles. Childcare articles are defined in entries 51 and 52 as ‘…any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of the children’. Whether a medical device is a childcare article for the purpose of entries 51 and 52 should be assessed on a case-by-case basis. In the example of a nebuliser, the device is intended for administering a medicinal product (apparatus to be used for treatment) and therefore it is not a childcare article and the restriction does not apply to it.