Order Pre/1567/2015, Of 28 July, That Amending The Appendices A And C Of Annex Ii Of The Royal Decree 1205 / 2011, From August 26, On The Safety Of Toys.

Original Language Title: Orden PRE/1567/2015, de 28 de julio, por la que se modifican los apéndices A y C del anexo II del Real Decreto 1205/2011, de 26 de agosto, sobre la seguridad de los juguetes.

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-8570

He Real Decree 1205 / 2011, of 26 of August, on the security of them toys, incorporated to the ordering legal Spanish the directive 2009 / 48 / EC of the Parliament European and of the Council, of 18 of June of 2009, on the security of them toys.

Said directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009, as well as the aforementioned Royal Decree, establish the General requirements for substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) in accordance with Regulation (EC) number 1272 / 2008 of the European Parliament and of the Council of 16 December 2008 , on classification, labelling and packaging of substances and mixtures, and by which is modified and repealed them directives 67 / 548 / EEC and 1999 / 45 / EC and is modifies the Regulation (CE) number 1907 / 2006. Such substances not can use is in them toys, in components or in parts of toys microstructurely different, except if are inaccessible to them children, are permitted by a Decision of the Commission or are contained in concentrations individual equal or minor to them concentrations relevant established for the classification of mixtures that them contain as substances CMR.

He Appendix to of the annex II of the Royal Decree 1205 / 2011, of 26 of August, contains the list of substances CMR and their uses authorized that is confined currently to the nickel.

Nickel is classified as carcinogenic category 2 substance pursuant to Regulation (EC) number 1272 / 2008 of the European Parliament and of the Council of 16 December 2008. In the absence of other specific requirements, toys may contain nickel in concentrations equal to or less than the relevant concentration established for the classification of mixtures containing it as substance CMR, namely, 1%.

For evaluate them risks for it health derivatives of the presence of nickel metal in them toys electric (plating, coating and alloys that allow the conductivity electric), the Commission requested an opinion to the Committee scientific of them risks health and environmental (SCHER). The SCHER says in its opinion 'Assessment of health risks from the use of metallic nickel in toys', adopted on 25 September 2012, there is no cancer risk from exposure to nickel to manipulate toys, toys from metallic nickel inhalation is extremely unlikely. The SCHER concluded, moreover, that the use of nickel in parts of toys designed to allow correct electrical operation, will result in a very low potential for exposure to nickel for oral and dermal, ingestion because of restrictions that is the release of nickel applicable to parts of toys which contain metals, insufficient accessibility of the parts that contain metals and the small size of parts that contain nickel and to allow the correct operation of the toys electric. Thus, the SCHER does not expect health risks from occurring. For these reasons, the Commission proceeded to modify the directive 2009 / 48 / CE of the Parliament European and of the Council, of 18 of June of 2009, by what is refers to the nickel.

To its time, the Appendix C of the annex II of the Real Decree 1205 / 2011, of 26 of August, specifies values limit for certain substances chemical used in toys destined to children minor of 36 months or in other toys intended to introduce is in it mouth.

Thus, the substance phosphate of tris (2-chloroethyl) (TCEP), number CAS 115-96-8, is an ester phosphoric used as plasticizer flame retardant in polymers. The TCEP is classified as a category 2 carcinogen and toxic for reproduction of category 1B in Regulation (EC) number 1272 / 2008 of the European Parliament and of the Council of 16 December 2008.

To evaluate them effects for the health of the TCEP in them toys and the adequacy of them limits generic of the TCEP as substance CMR established by the directive 2009 / 48 / CE of the Parliament European and of the Council, of 18 of June of 2009, the Commission requested an opinion to the SCHER.

In view of the results of the opinion delivered by the Committee, it was concluded that generic limits of 0.5% and 0.3% referred to in Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009, are inadequate to protect the health of children.

After a consultation to interested parties, "a sufficiently sensitive analytical method detection limit" set for the TCEP in 5 mg/kg.

In the same opinion the SCHER also assessed the TCEP halogenated substitutes phosphate tris [2-chloro-1-(chloromethyl) ethyl] (TDCP), CAS 13674-87-8 number, and phosphate (TCPP), CAS 13674-84-5 number tris(2-cloro-1-metiletilo). These replacements had been evaluated extensively in 2008 with arrangement to the Regulation (EEC) number 793 / 93 of the Council, of 23 of March of 1993, on evaluation and control of the risk of them substances existing.

In its opinion, the SCHER agreed with the conclusion of substitutes risk assessments: information from structures, physicochemical properties and toxicokinetic and mutagen TCEP, TDCP and TCPP profiles is sufficient to allow a qualitative extrapolation, which points to the possible carcinogenicity of the TCPP by a mechanism not genotoxic. The SCHER considers, on the basis of this extrapolation, as indicated for the TCEP can be applied to their substitutes halogenated if they are used in the manufacture of toys.

The TDCP is classified as carcinogen category 2 in Regulation (EC) number 1272 / 2008 of the European Parliament and of the Council of 16 December 2008, and the SCHER considers that the TCPP, although it is not classified, can be carcinogenic. Per everything said about the TCEP and having regard to the opinion of the SCHER, is also set at 5 mg/kg values limit of TDCP and TCPP.

As a result, the Commission proceeded to amend Appendix C to annex II of Directive 2009/48/EC EC of the European Parliament and of the Council of 18 June 2009, in what regards the TCEP, the TCPP and the TDCP.

Also, the substance Bisphenol A is a product chemical of high volume of production, very used for manufacture a great variety of products of consumption. It is used as a monomer in the manufacture of polycarbonate, which is used, among other things, for the manufacture of toys. In addition, found Bisphenol A in certain toys.

Bisphenol A is classified in the Regulation (EC) number 1272 / 2008 of the European Parliament and of the Council of 16 December 2008, as toxic for reproduction in category 2. In the absence of other specific requirements, toys may contain Bisphenol A in concentrations equal to or less than the relevant concentration established for the classification of mixtures containing it as a substance CMR, namely 5% from the 20 July 2013 and 3% from 1 June 2015. Cannot be excluded, however, that this concentration can lead to an increase in the exposure of infants to Bisphenol A, regarding the migration limit of 0,1 mg/l established for the Bisphenol A European norms EN 71-9:2005 + A1:2007, EN 71-10:2005 and EN 71-11:2005.

Bisphenol A was thoroughly evaluated in 2003 and 2008 pursuant to Regulation (EEC) 793/93 number of the Council of 23 March 1993 on the evaluation and control of the risks of existing substances (4). The final report of the risk assessment entitled «Update of the EU of the risk assessment of 4, 4' - isopropylidenediphenol (Bisphenol A)» exposed, among other things, that Bisphenol A presents endocrinomoduladora activity in several tests of screening in vitro and in vivo and concluded that it had to be further investigation to clear the unknowns concerning the potential for Bisphenol A to produce adverse effects on development at low doses. However, given their particular needs, children constitute a vulnerable group of consumers, and to achieve a high level of protection of children against the risks caused by the presence of chemical substances in toys, should be incorporated into directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009, the migration limit of 0,1 mg/l established for Bisphenol A.

Based on these considerations, the Commission of the European Union has valued the need to amend Appendices A and C of annex II to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009, in order to increase the safety of toys and, in particular, that of the intended for children under 36 months adopting for this reason the Commission the following directives; Directive 79/2014/EU Commission on June 20, 2014, that modifies, with regard to the TCEP, the TCPP and the TDCP, Appendix C to annex II of the directive 2009/48/EC of the European Parliament and of the Council on the safety of toys; Directive 2014 / 81 / EU of the Commission, of 23 of June of 2014, by which is modifies the Appendix C of the annex II of the directive 2009 / 48 / CE of the Parliament European and of the Council, on the security of them toys, in what respect to the Bisphenol to and directive 2014 / 84 / EU of the Commission, of 30 of June of 2014 , by which is modifies the appendix to of the annex II of the directive 2009 / 48 / EC of the Parliament European and of the Council on the safety of them toys, by what is refers to the nickel.


It should therefore amend the Royal Decree 1205 / 2011, from August 26, on the safety of toys, in order to incorporate into it the content of the abovementioned directives.

In processing this order hearing has been given to the sectors concerned and consulted the autonomous communities and cities of Ceuta and Melilla, having issued the report the Council of consumers and users.

This provision is dictates under the authorization contained in it available end third of the Real Decree 1205 / 2011, of 26 of August, on the security of them toys, that empowers to them Ministers of health, services social e equality and of industry, energy and tourism for modify joint or separately, in accordance with their respective powers, them annexes of the real Decree in order to keep them adapted to technical progress and, especially, to the provisions in Community legislation.

In his virtue, a proposal from the Minister of health, social services and equality and of the Minister of industry, energy and tourism, according to the Council of State, I have: single article. Modification of the Real Decree 1205 / 2011, from August 26, on the safety of toys.

Amending Appendices A and C of annex II of the Royal Decree 1205 / 26 August 2011, which are written as follows: one. The appendix to of the annex II, is drafted of the following way: «Appendix to list of substances CMR and their applications authorized of conformity with the annex II, part III, points 4, 5 and 6 substance classification use authorized nickel.»





WRC 2.





In the toys and in the components of toys manufactured with steel stainless.

Components of toys aimed at driving power.»





Two. He Appendix C of the annex II, is drafted of it following way: «Appendix C values limits specific for substances chemical used in toys destined to children minor of 36 months or in other toys intended to introduce is in it mouth substance not CAS value limit TCEP.»





115-96-8. 5 mg/kg (the limit of content).






TCPP.





13674-84-5. 5 mg/kg (the limit of content).






TDCP.





13674-87-8. 5 mg/kg (the limit of content).






Bisphenol A.





«80-05-7. 0.1 mg / l (limit of migration), with fix to the methods defined in the standards IN 71-10:2005 and IN 71-11:2005.»





Available end first. Incorporation of European Union law.

By this order is incorporate to the right Spanish it directive 2014 / 79 / EU of the Commission, of 20 of June of 2014, by which is modifies, in what respect to the TCEP, the TCPP and the TDCP, the Appendix C of the annex II of the directive 2009 / 48 / CE of the Parliament European and of the Council, relative to the security of them toys; the directive 2014 / 81 / EU of the Commission, of 23 of June of 2014, by which is modifies the Appendix C of the annex II of the directive 2009 / 48 / CE of the Parliament European and of the Council, on the security of them toys, in what regard to the Bisphenol to and it directive 2014 / 84 / EU of the Commission, of 30 of June of 2014 , by which is modifies the appendix to of the annex II of the directive 2009 / 48 / EC of the Parliament European and of the Council on the safety of them toys, by what is refers to the nickel.

Second final provision. Entry in force.

This order shall enter into force, in what refers to the modification of Appendix A of annex II the day following its publication in the "Official Gazette", so that the modification of Appendix C to annex II will do so on December 21, 2015.

Madrid, 28 July 2015.-the Vice-President of the Government and Minister of the Presidency, Soraya Sáenz de Santamaría Antón.