ddrg/super_eurlex huggingface dataset:
EN Official Journal of the European Union L 294/28

COMMISSION DIRECTIVE 2004/94/EC

of 15 September 2004

amending Council Directive 76/768/EEC as regards Annex IX

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on approximation of the laws of the Member States relating to cosmetic products (1), in particular the second subparagraph of Article 4a(1) thereof,

After consulting the Scientific Committee on Cosmetic products and Non-food Products intended for consumers,

Whereas:

(1) The contents of Annex IX to Directive 76/768/EEC should be established for the purpose of listing those alternative methods to animal testing that have been validated by the European Centre on Validation of Alternative Methods (ECVAM) of the Joint Research Centre and that are not listed in Annex V to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (2).

(2) As animal testing may not be replaced completely by an alternative method, it should be mentioned in Annex IX whether the alternative method fully or partially replaces animal testing.

(3) Directive 76/768/EEC should therefore be amended accordingly.

(4) There are at present, no alternative methods validated by ECVAM, other than those listed in Annex V to Council Directive 67/548/EEC.

(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The text in the Annex to this Directive is inserted in the Annex IX to Directive 76/768/EEC.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 September 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

2. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 15 September 2004. For the Commission Olli REHN Member of the Commission

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2004/88/EC (OJ L 287, 8.9.2004, p. 5).

(2) OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).
EN Official Journal of the European Union L 165/35

Corrigendum to Directive 2005/88/EC of the European Parliament and of the Council of 14 December 2005 amending Directive 2000/14/EC on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors

( Official Journal of the European Union L 344 of 27 December 2005 )

On page 45, in the table in Article 1(1), under the item ‘Welding and power generators’, in the second column, third row:

for:

‘10 > Pel’;

read:

‘Pel > 10’.
EN Official Journal of the European Union L 33/87

Corrigendum to Directive 2005/35/EC of the European Parliament and of the Council of 7 September 2005 on ship-source pollution and on the introduction of penalties for infringements

( Official Journal of the European Union L 255 of 30 September 2005 )

On page 15, in Article 16, in the first paragraph:

for:

‘Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 March 2007 and forthwith inform the Commission thereof.’

read:

‘Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 April 2007 and forthwith inform the Commission thereof.’
(6)

The review of daminozide revealed a number of open questions which were addressed by the EFSA. The Scientific Panel on Plant Health, Plant Protection Products and their Residues (PPR Panel) of the EFSA was asked to comment on the mechanism of action of the carcinogenic response of rodents to 1,1-dimethylhydrazide (UDMH) and to indicate whether or not a threshold could be derived for this effect. If yes, it was requested to indicate this value. The PPR Panel, having regard to the submitted questions, concluded (4) that, on the basis of the available data, it is not possible to identify the mechanism responsible for the carcinogenic action of UDMH in rodents. There is no in vitro evidence of genotoxicity of pure and oxidation-protected UDMH and in vivo studies are not available. In addition, the PPR Panel noted an apparent discrepancy in that daminozide long-term studies did not give rise to carcinogenicity in rats and mice at doses that should have produced internal doses of metabolically-formed UDMH at least one order of magnitude higher than those proven to be effective on direct testing. In addition, methylation of N7 guanine was found to be 50-fold higher in one study following oral administration of UDMH to rats, when compared to the corresponding data for daminozide. Thus, the PPR Panel considered that any conclusion on the mechanism of carcinogenicity of orally administered UDMH should be regarded to include a degree of uncertainty. The PPR Panel concluded that the weight of evidence is against a genotoxic mechanism. Among possible non-genotoxic mechanisms, altered regulation of cell proliferation or hormonal imbalance are plausible alternatives to genotoxicity, but these mechanisms have not been specifically investigated and thus a more definitive conclusion on the mechanism involved is not possible at the moment. In experimental testing of UDMH for carcinogenicity in rats and mice, no effects were observed at 0,09 mg/kg bw/day and 1,41 mg/kg bw/day, respectively. If the observed UDMH carcinogenicity is due to a non-genotoxic mechanism, the above indicated doses should be considered to be toxicological thresholds. However, taking together the uncertainties associated with the mechanism and the possibility that UDMH in greenhouse conditions may form oxidised derivatives that might be genotoxic, the PPR Panel is of the opinion that any use of these doses as thresholds should be undertaken only with due caution. The opinion was taken into consideration by the Standing Committee that concluded that the use of daminozide is acceptable under the specified conditions.
EN Official Journal of the European Union L 61/56

Corrigendum to Commission Directive 2006/64/CE of 18 July 2006 amending Council Directive 91/414/EEC to include clopyralid, cyprodinil, fosetyl and trinexapac as active substances

( Official Journal of the European Union L 206 of 27 July 2006 )

In the contents and in the title on page 107:

for:

‘Commission Directive 2006/64/CE …’,

read:

‘Commission Directive 2006/64/EC …’.
EN Official Journal of the European Union L 362/94

COMMISSION DIRECTIVE 2006/82/EC

of 23 October 2006

adapting Directive 91/321/EEC on infant formulae and follow-on formulae and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty of Accession of Bulgaria and Romania, and in particular Article 4(3) thereof,

Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,

Whereas:

(1) Pursuant to Article 56 of the Act of Accession, where acts which remain valid beyond 1 January 2007 require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary adaptations are to be adopted by the Commission in all cases where the Commission adopted the original act.

(2) The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the Institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

(3) Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae (1) and Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (2) should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directives 91/321/EEC and 1999/21/EC are amended as set out in the Annex.

Article 2

1. Member States shall adopt and publish, by the date of accession of Bulgaria and Romania to the European Union at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from the date of accession of Bulgaria and Romania to the European Union.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the fields covered by this Directive.

Article 3

This Directive shall enter into force subject to, and on the date of, the entry into force of the Treaty of Accession of Bulgaria and Romania.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 23 October 2006. For the Commission Olli REHN Member of the Commission

(1) OJ L 175, 4.7.1991, p. 35.

(2) OJ L 91, 7.4.1999, p. 29.
EN Official Journal of the European Union L 363/141

COUNCIL DIRECTIVE 2006/100/EC

of 20 November 2006

adapting certain Directives in the field of freedom of movement of persons, by reason of the accession of Bulgaria and Romania

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to the Treaty of Accession of Bulgaria and Romania (1), and in particular Article 4(3) thereof,

Having regard to the Act of Accession of Bulgaria and Romania, and in particular Article 56 thereof,

Having regard to the proposal from the Commission,

Whereas:

(1) Pursuant to Article 56 of the Act of Accession, where acts of the institutions remain valid beyond 1 January 2007, and require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the necessary acts are to be adopted by the Council, unless the Commission adopted the original act.

(2) The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directives 92/51/EEC, 77/249/EEC, 98/5/EC, 93/16/EEC, 77/452/EEC, 78/686/EEC, 78/687/EEC, 78/1026/EEC, 80/154/EEC, 85/433/EEC, 85/384/EEC and 2005/36/EC shall be amended as set out in the Annex.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the date of accession of Bulgaria and Romania to the European Union at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force subject to and on the date of the entry into force of the Treaty of Accession of Bulgaria and Romania.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 20 November 2006 For the Council The President J. KORKEAOJA

(1) OJ L 157, 21.6.2005, p. 11.

(2) OJ L 209, 24.7.1992, p. 25.

(3) OJ L 78, 26.3.1977, p. 17.

(4) OJ L 77, 14.3.1998, p. 36.

(5) OJ L 165, 7.7.1993, p. 1.

(6) OJ L 176, 15.7.1977, p. 1.

(7) OJ L 233, 24.8.1978, p. 1.

(8) OJ L 233, 24.8.1978 p. 10.

(9) OJ L 362, 23.12.1978, p. 1.

(10) OJ L 33, 11.2.1980, p. 1.

(11) OJ L 253, 24.9.1985, p. 37.

(12) OJ L 223, 21.8.1985, p. 15.

(13) OJ L 255 of 30.9.2005, p. 22.
EN Official Journal of the European Union L 195/29

COMMISSION DIRECTIVE 2007/48/EC

of 26 July 2007

amending Directive 2003/90/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (1), and in particular Article 7(2)(a) and (b) thereof,

Whereas:

(1) Commission Directive 2003/90/EC (2) was adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining the varieties, as far as such guidelines had been established. For other varieties that Directive provides that the guidelines of the International Union for the Protection of new Varieties of Plants (UPOV) are to apply.

(2) The CPVO and UPOV have since established further guidelines for a number of other species or have updated existing ones.

(3) Directive 2003/90/EC should therefore be amended accordingly.

(4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes I and II to Directive 2003/90/EC are replaced by the text in the Annex to this Directive.

Article 2

For examinations started before 1 November 2007 Member States may apply Directive 2003/90/EC in the version applying before its amendment by this Directive.

Article 3

Member States shall adopt and publish, by 31 October 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 November 2007.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 4

This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 26 July 2007. For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 193, 20.7.2002, p. 1. Directive as last amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 1).

(2) OJ L 254, 8.10.2003, p. 7. Directive as amended by Directive 2005/91/EC (OJ L 331, 17.12.2005, p. 24).
EN Official Journal of the European Union L 111/51

Corrigendum to Commission Directive 2008/113/EC of 8 December 2008 amending Council Directive 91/414/EEC to include several micro-organisms as active substances

( Official Journal of the European Union L 330 of 9 December 2008 )

On page 14, in the Annex, row 213, column ‘Common name, identification numbers’:

for:

‘T11’,

read:

‘T25’;

on page 14, in the Annex, row 213, column ‘Specific provisions’:

for:

‘T11’,

read:

‘T25’.
EN Official Journal of the European Union L 76/41

DIRECTIVE 2008/13/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 11 March 2008

repealing Council Directive 84/539/EEC on the approximation of the laws of the Member States relating to electro-medical equipment used in veterinary medicine

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1) Community policies on better regulation stress the importance of simplification of national and Community legislation as a crucial element in improving the competitiveness of enterprises and achieving the objectives of the Lisbon Agenda.

(2) The method of conformity assessment provided for by Council Directive 84/539/EEC (3) is no longer necessary for the purposes of the internal market and trade with third countries.

(3) The functioning of the internal market and the protection of users and animals can be better ensured by other Community legislation.

(4) Directive 84/539/EEC should therefore be repealed.

(5) The repeal of Directive 84/539/EEC entails that after 31 December 2008 the specimen mark of conformity of Annex III to that Directive will no longer be used and that the corresponding national implementing measures have to be repealed accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 84/539/EEC is hereby repealed with effect from 31 December 2008.

Article 2

Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2008. They shall forthwith communicate to the Commission the text of those measures and a correlation table between them and this Directive.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Article 3

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Done at Strasbourg, 11 March 2008. For the European Parliament The President H.-G. PÖTTERING For the Council The President J. LENARČIČ

(1) Opinion of 16 January 2008 (not yet published in the Official Journal).

(2) Opinion of the European Parliament of 29 November 2007 (not yet published in the Official Journal) and Council Decision of 14 February 2008.

(3) OJ L 300, 19.11.1984, p. 179. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
EN Official Journal of the European Union L 161/11

Corrigendum to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides

( Official Journal of the European Union L 309 of 24 November 2009 )

On page 75, Article 4(2), first subparagraph:

for:

‘2. By 14 December 2012, Member States shall communicate …’,

read:

‘2. By 26 November 2012, Member States shall communicate …’.

On page 75, Article 4(3), first subparagraph:

for:

‘3. By 14 December 2014, the Commission shall submit …’,

read:

‘3. By 26 November 2014, the Commission shall submit …’.

On page 75, Article 4(3), second subparagraph:

for:

‘By 14 December 2018, the Commission shall submit …’,

read:

‘By 26 November 2018, the Commission shall submit …’.

On page 75, Article 5(2):

for:

‘2. By 14 December 2013, Member States shall establish …’,

read:

‘2. By 26 November 2013, Member States shall establish …’.

On page 76, Article 6(4):

for:

‘4. The measures provided for in paragraphs 1 and 2 shall be established by 14 December 2015.’,

read:

‘4. The measures provided for in paragraphs 1 and 2 shall be established by 26 November 2015.’.

On page 76, Article 7(3):

for:

‘… the Commission, in cooperation with the Member States, shall develop by 14 December 2012 …’,

read:

‘… the Commission, in cooperation with the Member States, shall develop by 26 November 2012 …’.

On page 76, Article 8(2), first subparagraph:

for:

‘2. By 14 December 2016, Member States shall ensure …’,

read:

‘2. By 26 November 2016, Member States shall ensure …’.

On page 80, Article 17, second paragraph:

for:

‘Member States shall notify those provisions to the Commission by 14 December 2012 and …’,

read:

‘Member States shall notify those provisions to the Commission by 26 November 2012 and …’.

On page 81, Article 23(1), first subparagraph:

for:

‘1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 December 2011.’,

read:
EN Official Journal of the European Union L 355/92

Corrigendum to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys

( Official Journal of the European Union L 170 of 30 June 2009 )

On page 19:

Article 53(2):

for:

‘…, provided that such toys meet the requirements set out in Part 3 of Annex II to Directive 88/378/EEC and …’,

read:

‘…, provided that such toys meet the requirements set out in Section 3 of Part II of Annex II to Directive 88/378/EEC and …’;

Article 55, first paragraph:

for:

‘Directive 88/378/EEC, except Article 2(1) and Part 3 of Annex II, is repealed with effect from 20 July 2011. Article 2(1) thereof and Part 3 of Annex II thereto are repealed with effect from 20 July 2013.’,

read: