Proposal for a COUNCIL DIRECTIVE adapting certain directives in the field of food safety, veterinary and phytosanitary policy, by reason of the accession of Croatia
Date: 2013-02-08
Institutions: European Commission
Subjects: Croatia, accession to the European Union, approximation of laws, directive (EU), food safety, plant health control, veterinary legislation

EUROPEAN 
COMMISSION 

Brussels, 8.2.2013  
COM(2013) 62 final 

2013/0041 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

adapting certain directives in the field of food safety, veterinary and phytosanitary 
policy, by reason of the accession of Croatia 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The proposal for a Council Directive adapting certain directives in the field of food 
safety, veterinary and phytosanitary policy is necessitated by the upcoming accession 
of the Republic of Croatia to the European Union. 

The  Treaty  concerning  the  accession  of  the  Republic  of  Croatia  to  the  European 
Union1 was signed by all Member States of the European Union and the Republic of 
Croatia at Brussels on 9 December 2011. 

Article 3 (3) of the Treaty of Accession stipulates that it shall enter into force on 1 
July 2013 provided that all the instruments of ratification have been deposited before 
that date. 

Article 3(4) of the Treaty of Accession enables the institutions of the Union to adopt 
before accession measures referred to, inter alia, in Article 50 of the Act concerning 
the  conditions  of accession of the Republic of Croatia2. These measures  shall enter 
into  force  only  subject  to  and  on  the  date  of  the  entry  into  force  of  the  Treaty  of 
Accession. 

Article  50  of  the  Act  of  Accession  provides  that  where  acts  of  the  institutions 
adopted  prior  to  accession  require  adaptation  by  reason  of  accession,  and  the 
necessary  adaptations  have  not  been  provided  for  in  this  Act  or  its  Annexes,  the 
Council  or  the  Commission  (if  the  original  acts  were  adopted  by  the  Commission) 
shall adopt the necessary acts.  

Point 2 of the Final Act3 refers to the political agreement on a set of adaptations to be 
adopted  by  the  institutions  which  was  reached  between  the  Member  States  and 
Croatia  in  the  context  of  the  approval  of  the  Treaty  of  Accession;  the  High 
Contracting  Parties  of  the  Treaty  of  Accession  invited  the  Council  and  the 
Commission to adopt these adaptations before accession in accordance with Article 
50 of the Act of Accession, completed and updated where necessary to take account 
of the evolution of the law of the Union. 

The present proposal for a Council Directive covers the technical adaptations to all 
Council  directives  as  well  as to  European  Parliament  and  Council  directives  which 
require technical adaptation by reason of the accession of Croatia in the field of food 
safety,  veterinary  and  phytosanitary  policy  –  corresponding  to  negotiation  chapter 
12. 

This  proposal  is  part  of  a  series  of  proposals  for  Council  directives  by  the 
Commission  to  the  Council  which  regroup  the  technical  adaptations  to  Council 
directives as well as to European Parliament and Council directives corresponding to 
negotiation  chapters  into  separate  proposals  for  different  Council  directives.  This 

1 
2 
3 

OJ L 112, 24.4.2012, p. 10. 
OJ L 112, 24.4.2012, p. 21. 
OJ L 112, 24.4.2012, p. 95. 

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structure  is  designed  to  facilitate  the  transposition  of  the  directives  concerned  by 
Member States into their respective legal orders. The package of proposals for legal 
acts which the Commission has transmitted to the Council is composed of this series 
of  proposals  for  Council  directives  on  the  one  hand,  as  well  as  of  a  proposal  for  a 
single  Council  regulation  which  covers  the  relevant  European  Parliament  and 
Council  regulations  and  decisions  as  well  as  the  relevant  Council  regulations  and 
decisions on the other hand. This is in line with the approach which was taken in the 
past in view of the accession of Bulgaria and Romania4. 

It is foreseen that all the legal acts included in this package will be published in the 
Official Journal of the European Union at the same date. 

The present proposal and the other proposals included in this package will take into 
account  technical  adaptations  to  the  acquis  which  were  published  in  the  Official 
Journal  of  the  European  Union  until  1  September  2012.  The  reasons  for  this  are  to 
provide sufficient time for the legislative processes involved on the one hand, and for 
the  fulfilment  of  the  ensuing  transposition  and  notification  obligations  by  Member 
States as regards directives on the other hand. Adaptations which may be necessary 
to  the  acquis  published  in  the  Official  Journal  of  the  European  Union  after  1 
September  2012  will  be  foreseen  in  the  relevant  acts  themselves  or  done  at  a  later 
stage  through  the  appropriate  procedure.  In  addition,  the  Commission  intends  to 
informally provide a list of such legislation to Member States in early July 2013. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

As  this  proposal  is  of  a  purely  technical  nature  and  does  not  involve  any  political 
choices, consultations with interested parties or impact assessments would not have 
made sense. 

4 

OJ L 363, 20.12.2006, p. 1. 

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

The legal basis for the proposal is Article 50 of the Act concerning the conditions of 
accession of the Republic of Croatia. 

The  principles  of subsidiarity and  proportionality are fully respected. The action of 
the  Union  is  necessary  under  the  principle  of  subsidiarity  (Article  5  (3)  TEU) 
because  it  concerns  technical  adaptations  to  legal  acts  which  were  enacted  by  the 
Union.  The  proposal  respects  the  principle  of  proportionality  (Article  5  (4)  TEU) 
because it does not go beyond what is necessary to reach the objective pursued. 

4. 

BUDGETARY IMPLICATION 

The proposal has no budgetary implications.  

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2013/0041 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

adapting certain directives in the field of food safety, veterinary and phytosanitary 
policy, by reason of the accession of Croatia 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, 

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

Having regard to the Act of Accession of the Republic of Croatia, and in particular Article 50 
thereof, 

Having regard to the proposal from the Commission, 

Whereas: 

(1) 

(2) 

(3) 

1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

Pursuant to Article 50 of the Act of Accession, where acts which remain valid beyond 
1 July 2013 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 Council, unless the original act was adopted by 
the Commission. 

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. 

Directives  64/432/EEC1,  89/108/EEC2,  91/68/EEC3,  96/23/EC4,  97/78/EC5, 
2000/13/EC6, 
and 
2009/156/EC11 should therefore be amended accordingly, 

2003/99/EC10 

2000/75/EC7, 

2003/85/EC9, 

2002/99/EC8, 

OJ 121, 29.7.1964, p. 1977. 
OJ L 40, 11.2.1989, p. 34. 
OJ L 46, 19.2.1991, p. 19. 
OJ L 125, 23.5.1996, p. 10. 
OJ L 24, 30.1.1998, p. 9. 
OJ L 109, 6.5.2000, p. 29. 
OJ L 327, 22.12.2000, p. 74. 
OJ L 18, 23.1.2003, p. 11. 
OJ L 306, 22.11.2003, p. 1. 
OJ L 325, 12.12.2003, p. 31. 

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HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Directives  64/432/EEC,  89/108/EEC,  91/68/EEC,  96/23/EC,  97/78/EC,  2000/13/EC, 
2000/75/EC, 2002/99/EC, 2003/85/EC, 2003/99/EC and 2009/156/EC shall be amended as set 
out in the Annex. 

Article 2 

1. 

Member States shall adopt and publish, by the date of accession of the Republic of 
Croatia to the European Union at the latest, the laws, regulations and administrative 
provisions  necessary 
this  Directive.  They  shall  forthwith 
communicate to the Commission the text of those provisions. 

to  comply  with 

They  shall  apply  those  provisions  from  the  date  of  accession  of  the  Republic  of 
Croatia 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 field covered by this Directive. 

This Directive shall enter into force subject to, and as from the date of the entry into force of 
the Treaty of Accession of the Republic of Croatia. 

Article 3 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the Council 
The President 

11 

OJ L 192, 23.7.2010, p. 1. 

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FOOD SAFETY, VETERINARY AND PHYTOSANITARY POLICY 

I. FOOD SAFETY LEGISLATION 

ANNEX 

1. 

2. 

31989 L 0108:  Council  Directive  89/108/EEC  of  21  December  1988  on  the 
approximation of the laws of the Member States relating to quick-frozen foodstuffs 
for human consumption (OJ L 40, 11.2.1989, p. 34):  

The following is added to Article 8(1)(a): 

– 

'in Croatian: "brzo smrznuto".' 

32000 L 0013: Directive 2000/13/EC of the European Parliament and of the Council 
of 20 March 2000 on the approximation of the laws of the member States relating to 
the labelling, presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29): 

(a) 

In  Article  5(3)  second  subparagraph,  the  list  starting  with  ‘in  Bulgarian’  and 
ending with ‘bestrålad’ or ‘behandlad med joniserande strålning’ is replaced by 
the following : 

– 

'in Bulgarian: 

'облъчено' or 'обработено с йонизиращо лъчение', 

– 

in Spanish: 

'irradiado' or 'tratado con radiación ionizante', 

– 

in Czech: 

'ozářeno' or 'ošetřeno ionizujícím zářením', 

– 

in Danish: 

'bestrålet/…'  or  'strålekonserveret'  or  'behandlet  med  ioniserende  stråling'  or 
'konserveret med ioniserende stråling', 

– 

in German: 

'bestrahlt' or 'mit ionisierenden Strahlen behandelt', 

– 

in Estonian: 

'kiiritatud' or 'töödeldud ioniseeriva kiirgusega', 

– 

in Greek: 

'επεξεργασμένο με ιονίζουσα ακτινοβολία' or 'ακτινοβολημένο', 

– 

in English: 

'irradiated' or 'treated with ionising radiation', 

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– 

in French: 

'traité par rayonnements ionisants' or 'traité par ionisation', 

– 

in Croatian:  

'konzervirano zračenjem' or 'podvrgnuto ionizirajućem zračenju', 

– 

in Italian: 

'irradiato' or 'trattato con radiazioni ionizzanti', 

– 

in Latvian: 

'apstarots' or 'apstrādāts ar jonizējošo starojumu', 

– 

in Lithuanian: 

'apšvitinta' or 'apdorota jonizuojančiąja spinduliuote', 

– 

in Hungarian: 

'sugárkezelt'or 'ionizáló energiával kezelt', 

– 

in Maltese: 

'ittrattat bir-radjazzjoni' or 'ittrattat b'radjazzjoni jonizzanti', 

– 

in Dutch: 

'doorstraald'  or  'door  bestraling  behandeld'  oder  'met  ioniserende  stralen 
behandeld', 

– 

in Polish: 

'napromieniony' or 'poddany działaniu promieniowania jonizującego', 

– 

in Portuguese: 

'irradiado' or 'tratado por irradiação' or 'tratado por radiação ionizante', 

– 

in Romanian: 

'iradiate' or 'tratate cu radiaţii ionizate', 

– 

in Slovak: 

'ošetrené ionizujúcim žiarením', 

– 

in Slovenian: 

'obsevano' or 'obdelano z ionizirajočim sevanjem', 

— in Finnish: 

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'säteilytetty' or 'käsitelty ionisoivalla säteilyllä', 

– 

in Swedish: 

'bestrålad' or 'behandlad med joniserande strålning'.’ 

(b) 

In  Article  10(2)  the  list  starting  with  ‘in  Bulgarian’  and  ending  with  ‘sista 
förbrukningsdag’ is replaced by the following: 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

'in Bulgarian: 'използвай преди', 

in Spanish: 'fecha de caducidad', 

in Czech: 'spotřebujte do', 

in Danish: 'sidste anvendelsesdato', 

in German: 'verbrauchen bis', 

in Estonian: 'kõlblik kuni', 

in Greek: 'ανάλωση μέχρι', 

in English: 'use by', 

in French: 'à consommer jusqu'au', 

in Croatian: 'upotrijebiti do', 

in Italian: 'da consumare entro', 

in Latvian: 'izlietot līdz', 

in Lithuanian: 'tinka vartoti iki', 

in Hungarian: 'fogyasztható', 

in Maltese: 'uża sa', 

in Dutch: 'te gebruiken tot', 

in Polish: 'należy spożyć do', 

in Portuguese: 'a consumir até', 

in Romanian: 'expiră la data de', 

in Slovak: 'spotrebujte do', 

in Slovenian: 'porabiti do', 

in Finnish: 'viimeinen käyttöajankohta', 

in Swedish: 'sista förbrukningsdag'.’ 

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II. VETERINARY LEGISLATION 

1. 

2. 

31964  L  0432:  Council  Directive  64/432/EEC  of  26  June  1964  on  animal  health 
problems affecting intra-Community trade in bovine  animals  and swine (OJ  L 121, 
29.7.1964, p. 1977): 

In Article 2 (2), point (p) the following is added: 

– 

'Croatia: županija;'.  

31991  L  0068:  Council  Directive  91/68/EEC  of  28  January  1991  on  animal  health 
conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 
19.2.1991, p. 19): 

In Article 2(b), the list in point 14 starting with 'Belgium' and ending with 'județ' is 
replaced by the following: ' 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Belgium: 

province —provincie 

Germany: 

Regierungsbezirk 

Denmark: 

amt or island 

France: département 

Italy:  provincia 

Luxemburg  — 

Netherlands: 

rrv-kring 

England, Wales and Northern Ireland: county Scotland: 

United Kingdom: 
district or island area 

Ireland: 

county 

Greece: 

νομός 

Spain:  provincia 

Portugal: 
região autónoma 

continente:  distrito,  and  other  parts  of  Portugal's  territory: 

Austria: 

Bezirk 

Sweden: 

län 

Finland: 

lääni/län 

Czech Republic: 

kraj 

Estonia: 

maakond 

Cyprus: 

επαρχία (district) 

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– 

– 

– 

Latvia: rajons 

Lithuania: 

apskritis 

Hungary: 

megye 

–  Malta:  — 

– 

– 

– 

– 

– 

– 

Poland: powiat 

Slovenia: 

območje 

Slovakia: 

kraj 

Bulgaria: 

област  

Romania: 

județ; 

'Croatia: županija'. 

3. 

4. 

31996 L 0023: Council Directive 96/23/EC of 29 April 1996 on measures to monitor 
certain  substances  and  residues  thereof  in  live  animals  and  animal  products  and 
repealing  Directives  85/358/EEC  and  86/469/EEC  and  Decisions  89/187/EEC  and 
91/664/EEC (OJ L 125, 23.5.1996, p. 10): 

In Article 8(3), the following subparagraph is inserted after the third subparagraph: 

'Croatia  shall,  for  the  first time by 31  March 2014,  forward to  the Commission the 
results of their residue and substance detection plans and of their control measures.' 

31997  L  0078:  Council  Directive  97/78/EC  of  18  December  1997  laying  down  the 
principles  governing  the  organisation  of  veterinary  checks  on  products  entering  the 
Community from third countries (OJ L 24, 30.1.1998, p. 9): 

Annex I is replaced by the following: 

'ANNEX I 

TERRITORIES LISTED IN ARTICLE 1 

1. 

2. 

3. 

4. 

5. 

6. 

The territory of the Kingdom of Belgium. 

The territory of the Republic of Bulgaria. 

The territory of the Czech Republic. 

The territory of the Kingdom of Denmark with the 
exception of the Faroe Islands and Greenland. 

The territory of the Federal Republic of Germany. 

The territory of the Republic of Estonia. 

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7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

24. 

25. 

26. 

27. 

28. 

The territory of the Hellenic Republic. 

The territory of the Kingdom of Spain with the 
exception of Ceuta and Melilla. 

The territory of the French Republic. 

The territory of the Republic of Croatia. 

The territory of Ireland. 

The territory of the Italian Republic. 

The territory of the Republic of Cyprus. 

The territory of the Republic of Latvia. 

The territory of the Republic of Lithuania. 

The territory of the Grand Duchy of 
Luxembourg. 

The territory of the Republic of Hungary. 

The territory of the Republic of Malta. 

The territory of the Kingdom of the Netherlands 
in Europe. 

The territory of the Republic of Austria. 

The territory of the Republic of Poland. 

The territory of the Portuguese Republic. 

The territory of Romania. 

The territory of the Republic of Slovenia. 

The territory of the Slovak Republic. 

The territory of the Republic of Finland. 

The territory of the Kingdom of Sweden. 

The territory of the United Kingdom of Great 
Britain and Northern Ireland.' 

5. 

32000  L  0075:  Council  Directive  2000/75/EC  of  20  November  2000  laying  down 
specific  provisions  for  the  control  and  eradication  of  bluetongue  (OJ L 327, 
22.12.2000, p. 74): 

The title of Annex II is replaced by the following: 

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'ANNEX II 

A. 

LABORATORIO COMUNITARIO DE REFERENCIA DE LA FIEBRE 
CATARRAL OVINA  
EF-REFERENCELABORATORIUM FOR BLUETONGUE  
GEMEINSCHAFTLICHES REFERENZLABORATORIUM FÜR DIE 
BLAUZUNGENKRANKHEIT 
ΚΟΙΝΟΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΑΦΟΡΑΣ ΓΙΑ ΤΟΝ ΚΑΤΑΡΡΟΪΚΟ 
ΠΥΡΕΤΟ ΤΟΥ ΠΡΟΒΑΤΟΥ 
COMMUNITY REFERENCE LABORATORY FOR BLUETONGUE 
LABORATOIRE COMMUNAUTAIRE DE RÉFÉRENCE POUR LA 
FIÈVRE CATARRHALE DU MOUTON 
REFERENTNI LABORATORIJ ZAJEDNICE ZA BOLEST PLAVOG 
JEZIKA 
LABORATORIO COMUNITARIO DI RIFERIMENTO PER LA FEBBRE 
CATARRALE DEGLI OVINI 
COMMUNAUTAIR REFERENTIELABORATORIUM VOOR 
BLUETONGUE 
LABORATÓRIO COMUNITÁRIO DE REFERÊNCIA EM RELAÇÃO À 
FEBRE CATARRAL OVINA 
LAMPAAN BLUETONGUE-TAUTIA VARTEN NIMETTY YHTEISÖN 
VERTAILULABORATORIO 
GEMENSKAPENS REFERENSLABORATORIUM FÖR BLUETONGUE'. 

6. 

32002 L 0099: Council Directive 2002/99/EC of 16 December 2002 laying down the 
animal  health  rules  governing 
the  production,  processing,  distribution  and 
introduction  of  products  of  animal  origin  for  human  consumption  (OJ  L  18, 
23.1.2003, p. 11): 

Annex II is amended as follows: 

(a) the first indent of point 2 is replaced by the following: 

– 

'on the upper part, the name or ISO code of the Member State in capitals: AT, 
BE, DE, DK, ES, FI, FR, GR, HR, IE, IT, LU, NL, PT, SE and UK,'. 

(b) the third indent of point 2 is replaced by the following: 

– 

'on the lower part, one of the following sets of initials CE, EC, EF, EG, EK, EZ 
or EY,'. 

7. 

32003 L 0085: Council Directive 2003/85/EC of 29 September 2003 on Community 
measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC 
and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (OJ 
L 306, 22.11.2003, p. 1): 

In Part A of Annex XI, the following is inserted after the entry for France:  

'HR 

Croatia 

Hrvatski veterinarski institut 

Croatia' 

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10 000 Zagreb 

8. 

32003 L 0099: Directive 2003/99/EC of the European Parliament and of the Council 
of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending 
Council  Decision 90/424/EEC  and  repealing  Council  Directive  92/117/EEC  (OJ  L 
325, 12.12.2003, p. 31): 

In Article 9(1), the second subparagraph is replaced by the following: 

'Each Member State shall transmit to the Commission every year by the end of May, 
and  for  Croatia,  for  the  first  time,  by  the  end  of  May  2014,  a  report  on  trends  and 
sources of zoonoses, zoonotic agents and antimicrobial resistance, covering the data 
collected pursuant to Articles 4, 7, and 8 during the previous year. Reports, and any 
summaries of them, shall be made publicly available.' 

9. 

32009  L  0156:  Council  Directive  2009/156/EC  of  30  November  2009  on  animal 
health  conditions  governing  the  movement  and  importation  from  third  countries  of 
equidae (OJ L 192, 23.7.2010, p. 1): 

In Article 4(6), the introductory sentence of the first subparagraph is replaced by the 
following: 

'Where a Member State draws up or has drawn up a voluntary or compulsory control 
programme  for  a  disease  to  which  equidae  are  susceptible,  it  may  present  the 
programme  to  the  Commission,  within  six  months  from  4  July  1990  for  Belgium, 
Denmark,  Germany,  Ireland,  Greece,  Spain,  France,  Italy,  Luxembourg,  the 
Netherlands,  Portugal  and  the  United  Kingdom,  from  1  January  1995  for  Austria, 
Finland  and  Sweden,  from  1  May  2004  for  the  Czech  Republic,  Estonia,  Cyprus, 
Latvia,  Lithuania,  Hungary,  Malta,  Poland,  Slovenia  and  Slovakia,  from  1  January 
2007  for  Bulgaria  and  Romania  and  from  1  July  2013  for  Croatia,  outlining  in 
particular:' 

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