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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.

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Royal Decree 1205/2011 of 26 August 2011 on the safety of toys incorporated into the Spanish legal order Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys toys.

This Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009, as well as the royal decree cited above, lays down general requirements for substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures and amending and repealing them Directives 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006. Such substances may not be used in toys, in components or in parts of microstructurally different toys, except where they are inaccessible to children, are permitted by a Commission Decision or are contained in individual concentrations equal to or less than the relevant concentrations established for the classification of mixtures containing them as CMR substances.

Appendix A to Annex II to Royal Decree 1205/2011 of 26 August 2011 contains the list of CMR substances and their authorised uses which are currently restricted to nickel.

Nickel is classified as a category 2 carcinogen in accordance with Regulation (EC) No 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 CMR, namely 1%.

In order to assess the health risks associated with the presence of metallic nickel in electrical toys (plating, coating and alloys enabling electrical conductivity), the Commission asked the Committee for an opinion. Scientific of Health and Environmental Risks (SCHER). The CCRSM notes in its opinion "Assessment of the health risks of the use of metallic nickel in toys" adopted on 25 September 2012 that there is no cancer risk from exposure to nickel when handling the toys, since the inhalation of metallic nickel from toys is extremely unlikely. The CCRSM further concluded that the use of nickel in parts of toys intended to allow for the proper electrical operation of those toys, will result in a very low potential for exposure to nickel from oral and dermal intake due to the use of nickel. restrictions on the release of nickel applicable to parts of toys containing metals, the limited accessibility of parts containing metals and the reduced surface area of parts containing nickel and allowing for the release of nickel. correct operation of the electric toys. Thus, the SCHER does not expect health risks to occur. For these reasons, the Commission has proceeded to amend Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 on nickel.

In turn, Appendix C to Annex II to Royal Decree 1205/2011 of 26 August 2011 specifies limit values for certain chemical substances used in toys intended for children under 36 months of age or in other toys intended to be placed in the mouth.

Thus, the substance phosphate of tris (2-chloroethyl) (TCEP), CAS number 115 -96-8, is a phosphoric ester used as flame retardant plasticizer in polymers. TCEP is classified as a carcinogen of category 2 and toxic for reproduction category 1B in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.

For the purpose of assessing the health effects of TCEP on toys and the adequacy of generic TCEP limits as a CMR substance as set out in Directive 2009 /48/EC of the European Parliament and of the Council of 18 June The Commission requested an opinion from the CCRSM.

In the light of the results of the opinion delivered by that Committee, it was concluded that the generic limit values of 0,5% and 0,3% laid down 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.

Following a consultation with stakeholders, the "detection limit for a sufficiently sensitive analytical method" was set for the TCEP at 5 mg/kg.

In the same opinion, the CCRSM also evaluated the halogenated substitutes for TCEP phosphate of tris [2-chloro-1-(chloromethyl) ethyl] (TDCP), CAS number 13674-87-8, and tris phosphate (2-chloro-1-methylethyl) (TCPP), CAS number 13674-84-5. These substitutes had been thoroughly evaluated in 2008 under Council Regulation (EEC) No 793/93 of 23 March 1993 on the assessment and control of the risk of existing substances.

In its opinion, the SCHER agreed with the conclusion of the risk assessments of the substitutes: information from the structures, the physicochemical properties and the toxicocytic and mutagenic profiles TCEP, TDCP and TCPP is sufficient to allow for qualitative extrapolation, which points to the possible carcinogenicity of the TCPP by a non-genotoxic mechanism. The CCRSM considers, on the basis of this extrapolation, that what is indicated for TCEP can be applied to its halogenated substitutes if used in the manufacture of toys.

TDCP is classified as a category 2 carcinogen in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, and the CCRSM considers that the TCPP, although not classified, may be carcinogen. For all the above on the TCEP and given the opinion of the SCHER, the limit values for TDCP and TCPP should also be set at 5 mg/kg.

Consequently, the Commission has proceeded to amend Appendix C of Annex II to Directive 2009 /48/EC of the European Parliament and of the Council of 18 June 2009 concerning the TCEP, the TCPP and the TDCP.

The substance bisphenol A is also a high volume chemical product, widely used to manufacture a wide variety of consumer products. It is used as a monomer in the manufacture of polycarbonate, which is used, among other things, for the manufacture of toys. In addition, bisphenol A has been found in certain toys.

bisphenol A is classified in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 as toxic for category 2 reproduction. 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 CMR, namely 5% as from 20 July 2013 and 3% from the date of June 1, 2015. It cannot be excluded, however, that this concentration may lead to an increase in the exposure of young children to bisphenol A as compared to the migration limit of 0.1 mg/l that they set for bisphenol A European standards EN 71-9:2005 + A1:2007, EN 71-10:2005 and EN 71-11:2005.

bisphenol A was thoroughly evaluated in 2003 and 2008 in accordance with Council Regulation (EEC) No 793/93 of 23 March 1993 on the assessment and control of the risk of existing substances (4). The final risk assessment report entitled 'Updated EU Risk Assessment Report of 4,4'-isopropylidenediphenol (bisphenol A) ' exposed, inter alia, that bisphenol A presents endocrinomodulatory activity in several tests. in vitro and in vivo and concluded that further research had to be done to clear the unknowns regarding the potential of bisphenol A to produce adverse effects in low-dose development. However, given their particular needs, children constitute a vulnerable group of consumers and, in order to achieve a high level of protection for children in the face of the risks caused by the presence of chemicals in toys, it is appropriate to incorporate 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.

On the basis of these considerations, the European Union Commission has assessed 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 with the the purpose of increasing the safety of toys and, in particular, that of toys intended for children under 36 months of age, thereby adopting the following Directives; Commission Directive 2014 /79/EU of 20 June 2014 on the protection of toys amending, as regards the TCEP, the TCPP and the TDCP, Appendix C to Annex II to Directive 2009 /48/EC of the European Parliament and of the Council on the safety of toys; Commission Directive 2014 /81/EU of 23 June 2014 amending Appendix C to Annex II to Directive 2009 /48/EC of the European Parliament and of the Council, on the safety of toys, as regards bisphenol A and Commission Directive 2014 /84/EU of 30 June 2014 amending Appendix A to Annex II to Directive 2009 /48/EC of the European Parliament and of the Council on the the safety of toys, as regards nickel.

It is therefore appropriate to amend Royal Decree 1205/2011 of 26 August 2011 on the safety of toys in order to incorporate the content of the abovementioned directives into the same Directive.

In the processing of this order, the affected sectors have been heard and the autonomous communities and cities of Ceuta and Melilla have been consulted, with the Council of Consumers and Users having issued a report.

This provision is made pursuant to the authorisation contained in the Final Disposition third of Royal Decree 1205/2011 of 26 August 2011 on the safety of toys, which empowers the Ministers of Health, Services Social and Equality and Industry, Energy and Tourism to amend jointly or separately, in accordance with their respective powers, the annexes of the royal decree, in order to keep them adapted to technical progress and, in particular, to the provisions of the Community rules.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality and the Minister of Industry, Energy and Tourism, according to the State Council, I have:

Single item. Amendment of Royal Decree 1205/2011 of 26 August on the safety of toys.

Appendices A and C to Annex II to Royal Decree 1205/2011 of 26 August 2011 are amended as follows:

One. Appendix A of Annex II is worded as follows:

" Appendix A

List of CMR substances and their authorised uses in accordance with Annex II, Part III, points 4, 5 and 6

Substance

Classification

Authorized Use

CMR 2.

In toys and in components of toys made from stainless steel.

In the components of toys intended to drive the electrical current. "

Two. Appendix C to Annex II is worded as follows:

" Appendix C

Specific limits for chemical substances used in toys intended for children under 36 months of age or in other toys intended to be placed in the mouth

Substance

No CAS

Limit Value

TCEP.

115 -96-8.

5 mg/kg (content limit).

TCPP.

13674-84-5.

5 mg/kg (limit of contents)

TDCP.

13674-87-8.

5 mg/kg (content limit).

Bisphenol A.

80-05-7.

0.1 mg/l (migration limit), according to the methods defined in EN 71-10:2005 and EN 71-11:2005. "

Final disposition first. Incorporation of European Union law.

By this order, Commission Directive 2014 /79/EU of 20 June 2014 amending, as regards TCEP, the TCPP and the TDCP, Appendix C to Annex II to the Directive is incorporated into Spanish law. 2009 /48/EC of the European Parliament and of the Council on the safety of toys; Commission Directive 2014 /81/EU of 23 June 2014 amending Appendix C to Annex II to Directive 2009 /48/EC of the European Parliament and of the Council of the Council, on the safety of toys, as regards bisphenol A and Directive 2014 /84/EU of the European Parliament and of the Council Commission of 30 June 2014 amending Appendix A of Annex II to Directive 2009 /48/EC of the European Parliament and of the Council on the safety of toys, as regards nickel.

Final disposition second. Entry into force.

This order shall enter into force with regard to the amendment of Appendix A to Annex II on the day following that of its publication in the Official Gazette of the State, as the amendment to Appendix C of Annex II shall do so on 21 December 2015.

Madrid, July 28, 2015. -Government Vice President and Minister of the Presidency Soraya Saenz de Santamaria Anton.