Questions and Answers

REACH

Restrictions

Entry 51 and 52 of Annex XVII to REACH - Phthalates in toys and childcare articles

[748] What is the interpretation of the concept “which can be placed on the mouth” as laid down in the entry 52, concerning toys and childcare articles?
REACH
Restrictions
Version: 1.2
Latest update: 04/06/2015

Guideline on the interpretation of the concept “which can be placed in the mouth” as laid down in the entry 52 of Annex XVII to REACH Regulation 1907/2006.

This guideline aims at providing some criteria and examples to help identify those toys and childcare articles which can be placed in the mouth by children. The guideline lists the main criteria of “size dimension” and “accessible parts” (according to the EN 71-European Standard on the safety of toys) which would therefore facilitate the judgement - on a case by case – whether a toy or childcare article can be placed in the mouth by children.  The guideline also provides pictures as examples in order to better indicate which toys and childcare articles or parts of them can be taken into the mouth.  

[984] Do blankets and objects to facilitate the transport of children fall within the scope of Entries 51 and 52 of Annex XVII?
REACH
Restrictions
Version: 1.0
Latest update: 04/06/2015

The Guideline on the concept “which can be placed in the mouth” [See Q&A 748], provides certain clarifications concerning the types of childcare articles within the scope of Entries 51 and 52 of Annex XVII. For instance, sleeping bags are claimed to be articles designed to facilitate sleep, and should therefore fall under the scope of Entries 51 and 52. In addition, the guidance document explicitly contains a photo of a mattress cover which is considered as childcare articles, also explaining that certain parts (e.g. mattress protectors) can be placed in the mouth by children. [See Q&A 675]. 
 
Blankets are, in nature, articles similar to mattresses as both used in bed to facilitate the sleeping of children and therefore can be claimed to meet the broad definition of childcare articles. Furthermore, since blankets can be commonly placed in mouth by children, these can be considered within the scope of both Entries 51 and 52 of Annex XVII. 
 
The Guideline clarifies that “entry 52 of Annex XVII on what can be placed in the mouth by children also covers the accessible parts of articles such as push chairs, car seats, sleeping bags and bike seats which are intended to facilitate sleep and relaxation during transport”. Given that child seats and items which are used for transportation of children are quite similar in function and design to the above mentioned types of articles, they can be broadly considered as childcare articles [See Q&A 983]. In addition, it is noted that pictures of such types of childcare articles are also provided at the end of the Guideline. Over there, examples of mouthed items of such articles are provided to assist enforcers conclude whether they fall (or not) under the scope of entry 52. 
[985] In entry 51 of Annex XVII to REACH, does the concentration limit “0,1 % by weight of the plasticised material in toys and childcare articles” relate to the whole article or only part of it?”. For instance, if only the head of a doll contains more than 0.1 % w/w phthalates, should the concentration be calculated on the total weight of the plasticised material of the whole toy or only for the weight of the plasticised material of the head?
REACH
Restrictions
Version: 2.1
Latest update: 04/06/2015

The 0.1% limit was set up in order to eliminate the use of phthalates. Such limit was set up in order to be respected in each bit/piece of plasticised material by itself, regardless of whether there are other pieces or not. Therefore the reference to 0.1%, intended also as the sum up to the 3 phthalates, has to be calculated in each piece of plasticised material of each homogenous material. In the example referred to in the question the calculation should therefore be based on the weight of the plasticised material of the head of the doll and not the entire weight of all plasticised material of the whole toy.


[982] What is the definition of “toys”, in the context of restrictions in Annex XVII to REACH?
REACH
Restrictions
Version: 1.0
Latest update: 04/06/2015

A number of Annex XVII entries (Entries 5, 31, 43, 50 , 51 and 52) specifically refer to toys. The REACH Regulation does not  define “toys”. Toys are defined by Directive 2009/48/EC (hereinafter referred to as the Toys Safety Directive-TSD).
 
Article 2(1) of the TSD states: “This directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter referred to as toys)”.
Annex I to the TSD contains a more detailed list of products that are not considered as toys within the meaning of the Directive. Article 3 of the TSD defines certain types of toys such as “functional toy”, “aquatic toy”, “chemical toy” and “activity toy”. Furthermore, Article 2(2) of the TSD explicitly mentions that the TSD shall not apply to the following toys: (a) playground equipment intended for public use; (b) automatic playing machines, whether coin operated or not, intended for public use; (c) toy vehicles equipped with combustion engines; (d) toy steam engines; and (e) slings and catapults. It is considered that if the TSD definition of “toys” is used in Annex XVII to REACH, these exemptions will automatically form part of that definition.
 
The European Commission services have prepared an explanatory guidance document on the TSD, (http://ec.europa.eu/enterprise/sectors/toys/files/tsd-guidance/tsd_rev_1-6_explanatory_guidance_document_en.pdf) providing clarifications about its scope and definitions of certain categories of toys. Overall, the definition of toys in the TSD should be used to determine what we mean by “toys” for the purposes of restrictions in Annex XVII to REACH. Concerning toys exempted from the scope of the TSD (Article 2(2) of the TSD) these should also normally not be considered as “toys” for the purpose of the relevant REACH restrictions. In certain cases, it may be necessary to describe a class of toys to be covered by a restriction by reference to specific properties of the item.                                   
[983] What is the definition of “childcare articles”, in the context of restrictions in Annex XVII to REACH?
REACH
Restrictions
Version: 1.0
Latest update: 04/06/2015

A definition of “childcare articles” was inserted by the 22nd amendment of Council Directive 76/769/EEC, (which was repealed by REACH, Annex XVII) via the Directive 2005/84/EC of the European Parliament and of the Council. Directive 76/769/EEC was amended so that the following definition for childcare articles was added in its Article 1(3)c: “childcare article” means any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. Hence the intention of the legislator was to use this definition for the purpose of all the restriction provisions and thereby this to be applicable for the entire Directive 76/769/EEC. Therefore, the same definition appears in entries 51 and 52 of Annex XVII, providing an indication of what should be generally considered as a “childcare article” in the context of all Annex XVII (to REACH) provisions.