# L_2006362EN.01009401.xml

| 20.12.2006 | EN | Official Journal of the European Union | L 362/94 |
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20.12.2006

EN

Official Journal of the European Union

L 362/94

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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. |
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(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. |
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(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, |
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(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

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

1

(2)  
  OJ L 91, 7.4.1999, p. 29.

2

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ANNEX

FREE MOVEMENT OF GOODS

FOODSTUFFS

| 1. | 31991 L 0321: Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae (OJ L 175, 4.7.1991, p. 35), as amended by:






  — | 11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21), |
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1.

—

11994 N: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden (OJ C 241, 29.8.1994, p. 21),

| — | 31996 L 0004: Commission Directive 96/4/EC of 16.2.1996 (OJ L 49, 28.2.1996, p. 12), |
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31996 L 0004: Commission Directive 96/4/EC of 16.2.1996 (OJ L 49, 28.2.1996, p. 12),

| — | 31999 L 0050: Commission Directive 1999/50/EC of 25.5.1999 (OJ L 139, 2.6.1999, p. 29), |
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—

31999 L 0050: Commission Directive 1999/50/EC of 25.5.1999 (OJ L 139, 2.6.1999, p. 29),

| — | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33), |
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—

12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33),

| — | 32003 L 0014: Commission Directive 2003/14/EC of 10.2.2003 (OJ L 41, 14.2.2003, p. 37). |
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—

32003 L 0014: Commission Directive 2003/14/EC of 10.2.2003 (OJ L 41, 14.2.2003, p. 37).

| (a) | In Article 7(1), the following is added after the words ‘počiatočná dojčenská výživa’ and ‘následná dojčenská výživa’:






  ‘— | in Bulgarian:

  “храни за кърмачета” and “преходни храни”, |
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(a)

In Article 7(1), the following is added after the words ‘počiatočná dojčenská výživa’ and ‘následná dojčenská výživa’:

‘—

in Bulgarian:

“храни за кърмачета” and “преходни храни”,

| — | in Romanian:

  “preparate pentru sugari” and “pentru copii de vârstă mică”.’; |
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—

in Romanian:

“preparate pentru sugari” and “pentru copii de vârstă mică”.’;

| (b) | In Article 7(1), the following is added after the words ‘počiatočná dojčenská mliečna výživa’ and ‘následná dojčenská mliečna výživa’:






  ‘— | in Bulgarian:

  “млека за кърмачета” and “преходни млека”, |
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(b)

In Article 7(1), the following is added after the words ‘počiatočná dojčenská mliečna výživa’ and ‘následná dojčenská mliečna výživa’:

‘—

in Bulgarian:

“млека за кърмачета” and “преходни млека”,

| — | in Romanian:

  “lapte pentru sugari” and “pentru copii de vârstă mică”. ’. |
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—

in Romanian:

“lapte pentru sugari” and “pentru copii de vârstă mică”. ’.

| 2. | 31999 L 0021: Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29), as amended by:






  — | 12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33). |
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2.

—

12003 T: Act concerning the conditions of accession and the adjustments to the Treaties — Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic (OJ L 236, 23.9.2003, p. 33).

In Article 4(1), the list starting with ‘in Spanish’ and ending with ‘medicinska ändamål’, is replaced by the following list:

| ‘— | in Bulgarian:

  “Диетични храни за специални медицински цели” |
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‘—

in Bulgarian:

“Диетични храни за специални медицински цели”

| — | in Spanish:

  “Alimento dietético para usos médicos especiales” |
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—

in Spanish:

“Alimento dietético para usos médicos especiales”

| — | in Czech:

  “Dietní potravina určená pro zvláštní lékařské účely” |
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—

in Czech:

“Dietní potravina určená pro zvláštní lékařské účely”

| — | in Danish:

  “Levnedsmiddel/Levnedsmidler til særlige medicinske formål” |
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—

in Danish:

“Levnedsmiddel/Levnedsmidler til særlige medicinske formål”

| — | in German:

  “Diätetisches/Diätetische Lebensmittel für besondere medizinische Zwecke (Bilanzierte Diäten)” |
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—

in German:

“Diätetisches/Diätetische Lebensmittel für besondere medizinische Zwecke (Bilanzierte Diäten)”

| — | in Estonian:

  “Toit meditsiinilisel näidustusel kasutamiseks” |
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—

in Estonian:

“Toit meditsiinilisel näidustusel kasutamiseks”

| — | in Greek:

  “Διαιτητικά τρόφιμα για ειδικούς ιατρικούς σκοπούς” |
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—

in Greek:

“Διαιτητικά τρόφιμα για ειδικούς ιατρικούς σκοπούς”

| — | in English:

  “Food(s) for special medical purposes” |
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—

in English:

“Food(s) for special medical purposes”

| — | in French:

  “Aliment(s) diététique(s) destiné(s) à des fins médicales spéciales” |
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—

in French:

“Aliment(s) diététique(s) destiné(s) à des fins médicales spéciales”

| — | in Italian:

  “Alimento dietetico destinato a fini medici speciali” |
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—

in Italian:

“Alimento dietetico destinato a fini medici speciali”

| — | in Latvian:

  “Diētiskā pārtika cilvēkiem ar veselības traucējumiem” |
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—

in Latvian:

“Diētiskā pārtika cilvēkiem ar veselības traucējumiem”

| — | in Lithuanian:

  “Specialios medicininės paskirties maisto produktai” |
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—

in Lithuanian:

“Specialios medicininės paskirties maisto produktai”

| — | in Hungarian:

  “Speciális – gyógyászati célra szánt – tápszer” |
| --- | --- |

—

in Hungarian:

“Speciális – gyógyászati célra szánt – tápszer”

| — | in Maltese:

  “Ikel dijetetiku għal skopijiet mediċi speċifiċi” |
| --- | --- |

—

in Maltese:

“Ikel dijetetiku għal skopijiet mediċi speċifiċi”

| — | in Dutch:

  “Dieetvoeding voor medisch gebruik” |
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—

in Dutch:

“Dieetvoeding voor medisch gebruik”

| — | in Polish:

  “Dietetyczne środki spożywcze specjalnego przeznaczenia medycznego” |
| --- | --- |

—

in Polish:

“Dietetyczne środki spożywcze specjalnego przeznaczenia medycznego”

| — | in Portuguese:

  “Produto dietético de uso clínico” |
| --- | --- |

—

in Portuguese:

“Produto dietético de uso clínico”

| — | in Romanian:

  “Alimente dietetice pentru scopuri medicale speciale” |
| --- | --- |

—

in Romanian:

“Alimente dietetice pentru scopuri medicale speciale”

| — | in Slovak:

  “dietetická potravina na osobitné lekárske účely” |
| --- | --- |

—

in Slovak:

“dietetická potravina na osobitné lekárske účely”

| — | in Slovenian:

  “Dietno (dietetično) živilo za posebne zdravstvene namene” |
| --- | --- |

—

in Slovenian:

“Dietno (dietetično) živilo za posebne zdravstvene namene”

| — | in Finnish:

  “Kliininen ravintovalmiste/kliinisiä ravintovalmisteita” |
| --- | --- |

—

in Finnish:

“Kliininen ravintovalmiste/kliinisiä ravintovalmisteita”

| — | in Swedish:

  “Livsmedel för speciella medicinska ändamål” ’. |
| --- | --- |

—

in Swedish:

“Livsmedel för speciella medicinska ändamål” ’.

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