# C_2011159EN.01002301.xml

| 28.5.2011 | EN | Official Journal of the European Union | C 159/23 |
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28.5.2011

EN

Official Journal of the European Union

C 159/23

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Notification pursuant to Article 114, paragraph 4, 5 and 6 of the TFEU — Authorisation to maintain or introduce national measures being more stringent than provisions of an EU harmonisation measure

(Text with EEA relevance)

2011/C 159/11

| 1. | On 20 January 2011, the German Federal Government requested the Commission, pursuant to Article 114(4) of the Treaty on the Functioning of the European Union, the permission to retain the existing provisions provided in German law for the following five elements: lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances released from toy material, beyond the date of entry into force of Annex II, Part III, of Directive 2009/48/EC (1) (hereafter ‘the Directive’). |
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1.

On 20 January 2011, the German Federal Government requested the Commission, pursuant to Article 114(4) of the Treaty on the Functioning of the European Union, the permission to retain the existing provisions provided in German law for the following five elements: lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances released from toy material, beyond the date of entry into force of Annex II, Part III, of Directive 2009/48/EC (1) (hereafter ‘the Directive’).

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| 2. | The German Consumer Goods Ordinance (Bedarfsgegenständeverordnung) sets requirements for nitrosamines and nitrosatable substances. |
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2.

The German Consumer Goods Ordinance (Bedarfsgegenständeverordnung) sets requirements for nitrosamines and nitrosatable substances.

Bedarfsgegenständeverordnung

| 3. | The Consumer Goods Ordinance (Bedarfsgegenständeverordnung) requires that for nitrosamines and nitrosatable substances in toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth, the amount released as a result of migration must be so small as not to be laboratory detectable. |
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3.

The Consumer Goods Ordinance (Bedarfsgegenständeverordnung) requires that for nitrosamines and nitrosatable substances in toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth, the amount released as a result of migration must be so small as not to be laboratory detectable.

Bedarfsgegenständeverordnung

| 4. | The abovementioned Ordinance currently requires the migration of nitrosamines and nitrosatable substances to be below 0,01 mg/kg for nitrosamines and below 0,1 mg/kg for nitrosatable substances. |
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4.

The abovementioned Ordinance currently requires the migration of nitrosamines and nitrosatable substances to be below 0,01 mg/kg for nitrosamines and below 0,1 mg/kg for nitrosatable substances.

| 5. | The detailed provisions on nitrosamines and nitrosatable substances are laid down in Annex 4, point 1.b, and Annex 10, point 6, of the Consumer Goods Ordinance (Bedarfsgegenständeverordnung), published on the 23 December 1997, and most recently amended by the Ordinance of 6 March 2007. |
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5.

The detailed provisions on nitrosamines and nitrosatable substances are laid down in Annex 4, point 1.b, and Annex 10, point 6, of the Consumer Goods Ordinance (Bedarfsgegenständeverordnung), published on the 23 December 1997, and most recently amended by the Ordinance of 6 March 2007.

Bedarfsgegenständeverordnung

| 6. | The Second Equipment and Product Safety Act Ordinance (Zweite Verordnung zum Geräte- und Produktsicherheitsgesetz (Verordnung über die Sicherheit von Spielzeug) (2. GPSGV)) concerns in particular the following elements: lead, arsenic, mercury, barium and antimony. The limit values for the abovementioned elements contained in the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug — 2. GPSGV) are those laid down in Directive 88/378/EEC (2). The maximum daily bioavailability is 0,7 μg for lead, 0,1 μg for arsenic, 0,5 μg for mercury, 25 μg for barium and 0,2 μg for antimony. |
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6.

The Second Equipment and Product Safety Act Ordinance (Zweite Verordnung zum Geräte- und Produktsicherheitsgesetz (Verordnung über die Sicherheit von Spielzeug) (2. GPSGV)) concerns in particular the following elements: lead, arsenic, mercury, barium and antimony. The limit values for the abovementioned elements contained in the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug — 2. GPSGV) are those laid down in Directive 88/378/EEC (2). The maximum daily bioavailability is 0,7 μg for lead, 0,1 μg for arsenic, 0,5 μg for mercury, 25 μg for barium and 0,2 μg for antimony.

Zweite Verordnung zum Geräte- und Produktsicherheitsgesetz (Verordnung über die Sicherheit von Spielzeug) (2. GPSGV

Verordnung über die Sicherheit von Spielzeug — 2. GPSGV

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| 7. | The detailed provisions on the abovementioned elements are laid down in paragraph 2 of the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug — 2. GPSGV), most recently amended by the Ordinance of 6 March 2007. |
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7.

The detailed provisions on the abovementioned elements are laid down in paragraph 2 of the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug — 2. GPSGV), most recently amended by the Ordinance of 6 March 2007.

Verordnung über die Sicherheit von Spielzeug — 2. GPSGV

| 8. | The Directive lays down rules on the safety of toys and on their free movement in the Community. According to Article 54, Member States shall bring into force national provisions complying with this Directive by 20 January 2011, and they shall apply them as from 20 July 2011. Part III of Annex II of the Directive will be applicable as from 20 July 2013. |
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8.

The Directive lays down rules on the safety of toys and on their free movement in the Community. According to Article 54, Member States shall bring into force national provisions complying with this Directive by 20 January 2011, and they shall apply them as from 20 July 2011. Part III of Annex II of the Directive will be applicable as from 20 July 2013.

| 9. | The Directive contains, in Annex II, part III, point 8, specific values for nitrosamines and nitrosatable substances. These substances shall be prohibited for use in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances. |
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9.

The Directive contains, in Annex II, part III, point 8, specific values for nitrosamines and nitrosatable substances. These substances shall be prohibited for use in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances.

| 10. | Point 13 of part III of Annex II of the Directive contains specific migration limits for several elements, including lead, arsenic, mercury, barium and antimony. Three different migration limits exist, related to the type of toy material: dry, brittle, powder-like or pliable toy material, liquid or sticky toy material and scraped-off toy material. The following limits shall not be exceeded: 13,5, 3,4 and 160 mg/kg for lead, 3,8, 0,9 and 47 mg/kg for arsenic, 7,5, 1,9 and 94 mg/kg for mercury, 4 500, 1 125 and 56 000 mg/kg for barium, and 45, 11,3 and 560 mg/kg for antimony. |
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10.

Point 13 of part III of Annex II of the Directive contains specific migration limits for several elements, including lead, arsenic, mercury, barium and antimony. Three different migration limits exist, related to the type of toy material: dry, brittle, powder-like or pliable toy material, liquid or sticky toy material and scraped-off toy material. The following limits shall not be exceeded: 13,5, 3,4 and 160 mg/kg for lead, 3,8, 0,9 and 47 mg/kg for arsenic, 7,5, 1,9 and 94 mg/kg for mercury, 4 500, 1 125 and 56 000 mg/kg for barium, and 45, 11,3 and 560 mg/kg for antimony.

| 11. | By going further in terms of placing on the market, the current provisions contained in the German Ordinances are therefore more stringent than the legislation that will be applicable at EU level as from 20 July 2013. |
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11.

By going further in terms of placing on the market, the current provisions contained in the German Ordinances are therefore more stringent than the legislation that will be applicable at EU level as from 20 July 2013.

| 12. | The German Federal Government argues that maintaining the current provisions is necessary in order to protect children's health, which needs appropriate protection from exposure to harmful chemical substances. |
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12.

The German Federal Government argues that maintaining the current provisions is necessary in order to protect children's health, which needs appropriate protection from exposure to harmful chemical substances.

| 13. | For nitrosamines and nitrosatable substances, the German Federal Government considers that the limits contained in the Directive (0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances) are appropriate only with regards to balloons. Balloons are only put shortly in the mouth during blowing up, while the contact scenario for other toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth is longer. Therefore the exposure to nitrosamines in balloons is less important. For the toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth, the limits should be based on the ALARA (as low as reasonably achievable) principle in order to provide an appropriate level of safety. Therefore, the German Federal Government considers that maintaining the detection limits below 0,01 mg/kg for nitrosamines and 0,1 mg/kg for nitrosatable substances will ensure an adequate level of protection for children when using rubber toys intended or likely to be placed in the mouth. |
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13.

For nitrosamines and nitrosatable substances, the German Federal Government considers that the limits contained in the Directive (0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances) are appropriate only with regards to balloons. Balloons are only put shortly in the mouth during blowing up, while the contact scenario for other toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth is longer. Therefore the exposure to nitrosamines in balloons is less important. For the toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth, the limits should be based on the ALARA (as low as reasonably achievable) principle in order to provide an appropriate level of safety. Therefore, the German Federal Government considers that maintaining the detection limits below 0,01 mg/kg for nitrosamines and 0,1 mg/kg for nitrosatable substances will ensure an adequate level of protection for children when using rubber toys intended or likely to be placed in the mouth.

| 14. | With regards to certain elements, the German Federal Government argues that the limits for lead, arsenic, mercury, barium and antimony as established in the Directive are too high and may endanger the health and safety of children. The German authorities are aware that these limits are based on available tolerable daily intakes provided by the scientific community. However, using these tolerable daily intakes resulted in increasing the limits of the abovementioned heavy elements. This increase is considered as unnecessary by the German Federal Government. For lead and arsenic, only the ALARA principle can ensure an appropriate level of protection for children. For mercury, barium and antimony the German Federal Government argues that the lower limits contained in the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug — 2. GPSGV) considered as good manufacturing practices, should be maintained in order to ensure a higher level of protection for children. |
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14.

With regards to certain elements, the German Federal Government argues that the limits for lead, arsenic, mercury, barium and antimony as established in the Directive are too high and may endanger the health and safety of children. The German authorities are aware that these limits are based on available tolerable daily intakes provided by the scientific community. However, using these tolerable daily intakes resulted in increasing the limits of the abovementioned heavy elements. This increase is considered as unnecessary by the German Federal Government. For lead and arsenic, only the ALARA principle can ensure an appropriate level of protection for children. For mercury, barium and antimony the German Federal Government argues that the lower limits contained in the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug — 2. GPSGV) considered as good manufacturing practices, should be maintained in order to ensure a higher level of protection for children.

Verordnung über die Sicherheit von Spielzeug — 2. GPSGV

| 15. | The present notification will be assessed in the light of Directive 2009/48/EC and in accordance with Article 114(4) of the TFEU. The Commission has six months to approve or reject the notified measures, during which it shall check that they do not constitute a mean of arbitrary discrimination or a disguised restriction to trade and that they do not create unnecessary and disproportionate barriers to the functioning of the internal market. |
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15.

The present notification will be assessed in the light of Directive 2009/48/EC and in accordance with Article 114(4) of the TFEU. The Commission has six months to approve or reject the notified measures, during which it shall check that they do not constitute a mean of arbitrary discrimination or a disguised restriction to trade and that they do not create unnecessary and disproportionate barriers to the functioning of the internal market.

| 16. | Any comment on the present notification shall be sent to the Commission within 30 days from the publication of this notice. Any comment submitted after these 30 days will not be taken into account. |
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16.

Any comment on the present notification shall be sent to the Commission within 30 days from the publication of this notice. Any comment submitted after these 30 days will not be taken into account.

| 17. | Further details about the German notification can be obtained from:





  European Commission |
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| Directorate-General for Enterprise and Industry |
| DG ENTR. F3 — International Regulatory Agreements and Toys’ Safety |
| Ms Florina-Andreea Pantazi |
| Tel. +32 22975791 |
| E-mail: florina-andreea.pantazi@ec.europa.eu |

17.

Further details about the German notification can be obtained from:

European Commission

Directorate-General for Enterprise and Industry

DG ENTR. F3 — International Regulatory Agreements and Toys’ Safety

Ms Florina-Andreea Pantazi

Tel. +32 22975791

E-mail: florina-andreea.pantazi@ec.europa.eu

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(1)  Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (Text with EEA relevance), OJ L 170, 30.6.2009, p. 1.

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(2)  Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys (OJ L 187, 16.7.1988, p. 1).

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