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Directive 2008/112/EC of the European Parliament and of the CouncilShow full title

Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC of the European Parliament and of the Council in order to adapt them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)

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Article 2U.K.Amendments to Directive 88/378/EEC

Directive 88/378/EEC is hereby amended as follows:

1.

the word ‘preparation’ or ‘preparations’ within the meaning of Article 3(2) of Regulation (EC) No 1907/2006, in its version of 30 December 2006, shall be replaced by ‘mixture’ or ‘mixtures’ respectively throughout the text;

2.

from 1 December 2010, in section 2 of part II of Annex II, point (b) shall be replaced by the following:

‘(b)

Toys must not contain, as such, substances or mixtures which may become flammable due to the loss of non-flammable volatile components if, for reasons essential to their functioning, in particular materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, such toys contain mixtures which are dangerous as defined in Directive 67/548/EEC or substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures(1):

(i)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(ii)

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(iii)

hazard class 4.1;

(iv)

hazard class 5.1.;

3.

from 1 June 2015, in section 2 of part II of Annex II, point (b) shall be replaced by the following:

‘(b)

Toys must not contain, as such, substances or mixtures which may become flammable due to the loss of non-flammable volatile components if, for reasons essential to their functioning, in particular materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, such toys contain substances or mixtures fulfilling the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures(2):

(i)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(ii)

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(iii)

hazard class 4.1;

(iv)

hazard class 5.1.;

4.

from 1 December 2010, in section 3 of part II of Annex II, the first paragraph of point 3 shall be replaced by the following:

‘3.

Toys must not contain mixtures which are dangerous within the meaning of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(3) or substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(a)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(b)

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(c)

hazard class 4.1;

(d)

hazard class 5.1,

in amounts which may harm the health of children using them. In any event it is strictly forbidden to include, in a toy, such substances or mixtures if they are intended to be used as such while the toy is being used.;

5.

from 1 June 2015, in section 3 of part II of Annex II, the first paragraph of point 3 shall be replaced by the following:

‘3.

Toys must not contain substances or mixtures fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(a)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(b)

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(c)

hazard class 4.1;

(d)

hazard class 5.1;

in amounts which may harm the health of children using them. In any event it is strictly forbidden to include, in a toy, such substances or mixtures if they are intended to be used as such while the toy is being used.;

6.

from 1 December 2010, in section 4 of Annex IV, the title and point (a) shall be replaced by the following:

4.Toys containing inherently dangerous substances or mixtures. Chemical toys

(a)

Without prejudice to the application of the provisions laid down in Regulation (EC) No 1272/2008, the instructions for use of toys containing mixtures which are inherently dangerous or substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(i)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(ii)

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(iii)

hazard class 4.1;

(iv)

hazard class 5.1;

shall bear a warning of the hazardous nature of these substances or mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them, which shall be specified concisely according to the type of toy. The first aid to be given in the event of serious accidents resulting from the use of this type of toy shall also be mentioned. It shall also be stated that the toys must be kept out of reach of very young children.;

7.

from 1 June 2015, in section 4 of Annex IV, the title and point (a) shall be replaced by the following:

4.Toys containing inherently dangerous substances or mixtures. Chemical toys

(a)

Without prejudice to the application of the provisions laid down in Regulation (EC) No 1272/2008, the instructions for use of toys containing substances or mixtures fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to that Regulation:

(i)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(ii)

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(iii)

hazard class 4.1;

(iv)

hazard class 5.1;

shall bear a warning of the hazardous nature of these substances or mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them, which shall be specified concisely according to the type of toy. The first aid to be given in the event of serious accidents resulting from the use of this type of toy shall also be mentioned. It shall also be stated that the toys must be kept out of reach of very young children..

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