Proposal for a Regulation of the European Parliament and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC, as amended by Decision 2006/512/EC, with regard to the regulatory procedure with scrutiny - Part Two - Adaptation to the regulatory procedure with scrutiny
Date: 2007-12-19
Institutions: European Commission
Subjects: European Commission, capacity to exercise rights, comitology, institutional reform, interinstitutional relations, legislative-executive relations, power of implementation, powers of the institutions (EU)

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 19.12.2007 
COM(2007) 824 final 

2007/0293 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

adapting a number of instruments subject to the procedure referred to in Article 251 of 
the Treaty to Council Decision 1999/468/EC, as amended by Decision 2006/512/EC, with 
regard to the regulatory procedure with scrutiny 

Adaptation to the regulatory procedure with scrutiny 
Part Two 

(presented by the Commission) 

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TABLE OF CONTENTS 

ANNEX...................................................................................................................................... 8 

1. 

Humanitarian aid.......................................................................................................... 8 

1.1. 

Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid 8 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

2.6. 

2.7. 

2.8. 

2.9. 

3. 

3.1. 

3.2. 

Enterprise ..................................................................................................................... 9 

Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of 
the Member States relating to aerosol dispensers ........................................................ 9 

Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions 
relating to the placing on the market and supervision of explosives for civil uses.... 10 

Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 
on the approximation of the laws of the Member States relating to the noise emission 
in the environment by equipment for use outdoors.................................................... 11 

Regulation (EC) No 2003/2003 of the European Parliament and of the Council 
of 13 October 2003 relating to fertilisers ................................................................... 12 

Directive 2004/9/EC of the European Parliament and of the Council of 
11 February 2004 on the inspection and verification of good laboratory practice 
(GLP) (codified version) ............................................................................................ 13 

Directive 2004/10/EC of the European Parliament and of the Council of 
11 February 2004 on the harmonisation of laws, regulations and administrative 
provisions relating to the application of the principles of good laboratory practice and 
the verification of their applications for tests on chemical substances 
(codified version) ....................................................................................................... 14 

Regulation (EC) No 273/2004 of the European Parliament and of the Council 
of 11 February 2004 on drug precursors .................................................................... 15 

Regulation (EC) No 648/2004 of the European Parliament and of the Council 
of 31 March 2004 on detergents ................................................................................ 16 

Regulation (EC) No 726/2004 of the European Parliament and of the Council 
of 31 March 2004 laying down Community procedures for the authorisation and 
supervision of medicinal products for human and veterinary use and 
establishing a European Medicines Agency .............................................................. 18 

Environment............................................................................................................... 21 

Council Directive 82/883/EEC of 3 December 1982 on procedures for the 
surveillance and monitoring of environments concerned by waste from the titanium 
dioxide industry.......................................................................................................... 21 

Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, 
and in particular of the soil, when sewage sludge is used in agriculture ................... 21 

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3.3. 

3.4. 

3.5. 

3.6. 

3.7. 

3.8. 

3.9. 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

4.5. 

4.6. 

5. 

5.1. 

European Parliament and Council Directive 94/62/EC of 20 December 1994 on 
packaging and packaging waste ................................................................................. 22 

Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur 
content of certain liquid fuels and amending Directive 93/12/EEC .......................... 24 

Directive 2001/81/EC of the European Parliament and of the Council of 
23 October 2001 on national emission ceilings for certain atmospheric pollutants .. 25 

Directive 2003/87/EC of the European Parliament and of the Council of 
13 October 2003 establishing a scheme for greenhouse gas emission allowance 
trading within the Community and amending Council Directive 96/61/EC.............. 25 

Regulation (EC) No 850/2004 of the European Parliament and of the Council 
of 29 April 2004 on persistent organic pollutants and amending Directive 
79/117/EEC ................................................................................................................ 27 

Directive 2004/107/EC of the European Parliament and of the Council of 
15 December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic 
aromatic hydrocarbons in ambient air........................................................................ 29 

Regulation (EC) No 1013/2006 of the European Parliament and of the Council 
of 14 June 2006 on shipments of waste ..................................................................... 31 

Eurostat ...................................................................................................................... 34 

Council Regulation (EEC) No 3924/91 of 19 December 1991 on 
the establishment of a Community survey of industrial production .......................... 34 

Council Directive 96/16/EC of 19 March 1996 on statistical surveys of 
milk and milk products .............................................................................................. 36 

Directive 2001/109/EC of the European Parliament and of the Council 
of 19 December 2001 concerning the statistical surveys to be carried out by the 
Member States in order to determine the production potential of plantations of 
certain species of fruit trees........................................................................................ 37 

Regulation (EC) No 91/2003 of the European Parliament and of the Council 
of 16 December 2002 on rail transport statistics........................................................ 38 

Regulation (EC) No 437/2003 of the European Parliament and of the Council 
of 27 February 2003 on statistical returns in respect of the carriage of passengers, 
freight and mail by air ................................................................................................ 40 

Regulation (EC) No 48/2004 of the European Parliament and of the Council of 
5 December 2003 on the production of annual Community statistics on the steel 
industry for the reference years 2003-2009 ............................................................... 42 

Internal market ........................................................................................................... 43 

Directive 2004/25/EC of the European Parliament and of the Council of 
21 April 2004 on takeover bids.................................................................................. 43 

6. 

Health and consumer protection................................................................................. 44 

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6.1. 

6.2. 

6.3. 

6.4. 

6.5. 

6.6. 

6.7. 

6.8. 

6.9. 

Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound 
feedingstuffs............................................................................................................... 44 

Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in 
animal nutrition .......................................................................................................... 45 

Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, 
amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and 
repealing Directive 77/101/EEC ................................................................................ 47 

Directive 2002/32/EC of the European Parliament and of the Council of 
7 May 2002 on undesirable substances in animal feed .............................................. 48 

Regulation (EC) No 998/2003 of the European Parliament and of the Council 
of 26 May 2003 on the animal health requirements applicable to the non-commercial 
movements of pet animals and amending Council Directive 92/65/EEC.................. 50 

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. ......... 51 

Regulation (EC) No 852/2004 of the European Parliament and of the Council 
of 29 April 2004 on the hygiene of foodstuffs........................................................... 53 

Regulation (EC) No 853/2004 of the European Parliament and of the Council 
of 29 April 2004 laying down specific hygiene rules for food of animal origin ....... 54 

Regulation (EC) No 854/2004 of the European Parliament and of the Council 
of 29 April 2004 laying down specific rules for the organisation of official controls 
on products of animal origin intended for human consumption ................................ 56 

6.10.  Regulation (EC) No 183/2005 of the European Parliament and of the Council 

of 12 January 2005 laying down requirements for feed hygiene ............................... 57 

7. 

7.1. 

7.2. 

7.3. 

7.4. 

Energy and transport .................................................................................................. 58 

Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording 
equipment in road transport ....................................................................................... 58 

Council Directive 97/70/EC of 11 December 1997 setting up a harmonised safety 
regime for fishing vessels of 24 metres in length and over........................................ 59 

Council Directive 1999/35/EC of 29 April 1999 on a system of 
mandatory surveys for the safe operation of regular ro-ro ferry and 
high-speed passenger craft services ........................................................................... 60 

Regulation (EC) No 417/2002 of the European Parliament and of the Council 
of 18 February 2002 on the accelerated phasing-in of double hull or equivalent 
design requirements for single hull oil tankers and repealing Council Regulation 
(EC) No 2978/94 ........................................................................................................ 62 

7.5. 

Regulation (EC) No 782/2003 of the European Parliament and of the Council 
of 14 April 2003 on the prohibition of organotin compounds on ships ..................... 63 

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7.6. 

7.7. 

7.8. 

7.9. 

Directive 2004/8/EC of the European Parliament and of the Council of 
11 February 2004 on the promotion of cogeneration based on a useful heat 
demand in the internal energy market and amending Directive 92/42/EEC.............. 64 

Directive 2004/52/EC of the European Parliament and of the Council of 29 April 
2004 on the interoperability of electronic road toll systems in the Community........ 66 

Regulation (EC) No 725/2004 of the European Parliament and of the Council 
of 31 March 2004 on enhancing ship and port facility security................................. 67 

Regulation (EC) No 789/2004 of the European Parliament and of the Council 
of 21 April 2004 on the transfer of cargo and passenger ships between registers 
within the Community and repealing Council Regulation (EEC) No 613/91 ........... 68 

7.10.  Directive 2005/44/EC of the European Parliament and of the Council of 

7 September 2005 on harmonised river information services (RIS) on inland 
waterways in the Community .................................................................................... 69 

7.11.  Directive 2005/65/EC of the European Parliament and of the Council of 

26 October 2005 on enhancing port security ............................................................. 70 

Chronological index ................................................................................................................. 71 

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2007/0293 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

adapting a number of instruments subject to the procedure referred to in Article 251 of 
the Treaty to Council Decision 1999/468/EC, as amended by Decision 2006/512/EC, with 
regard to the regulatory procedure with scrutiny 

Adaptation to the regulatory procedure with scrutiny 
Part Two 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Articles 37, 44(1), 71, 80(2), 95, 152(4)(b), 175(1), 179 and 285 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the European Central Bank3, 

Following consultation of the Committee of the Regions, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas: 

(1) 

Council  Decision  1999/468/EC  of  28 June  1999  laying  down  the  procedures  for  the 
exercise  of  implementing  powers  conferred  on  the  Commission5  was  amended  by 
Decision  2006/512/EC,  which  introduced  the  regulatory  procedure  with  scrutiny  for 
measures  of  general  scope  designed  to  amend  non-essential  elements  of  a  basic 
instrument adopted in accordance with the procedure laid down in Article 251 of the 
Treaty,  inter  alia  by  deleting  some  of  those  elements  or  by  supplementing  the 
instrument by the addition of new non-essential elements. 

1 
2 
3 
4 
5 

OJ C [...], [...], p. [...]. 
OJ C [...], [...], p. [...]. 
OJ C [...], [...], p. [...]. 
OJ C [...], [...], p. [...]. 
OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 

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(2) 

(3) 

In accordance with the joint statement of the European Parliament, the Council and the 
Commission6  on  Decision  2006/512/EC,  for  this  new  procedure  to  be  applicable  to 
instruments adopted in accordance with the procedure laid down in Article 251 of the 
Treaty  which  are  already  in  force,  those  instruments  must  be  adopted  in  accordance 
with the applicable procedures. 

The amendments that need to be made to instruments for this purpose concern only the 
committee procedures and so, in the case of Directives, do not require transposition by 
the Member States, 

HAVE ADOPTED THIS REGULATION: 

The  instruments  listed  in  the  Annex  are  hereby  adapted,  in  accordance  with  that  Annex,  to 
Decision 1999/468/EC, as amended by Decision 2006/512/EC. 

Article 1 

References  to  provisions  of  the  instruments  listed  in  the  Annex  are  understood  to  be 
references to those provisions as adapted by this Regulation. 

Article 2 

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

Article 3 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

6 

OJ C 255, 21.10.2006, p. 1. 

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ANNEX 

1. 

HUMANITARIAN AID 

1.1. 

Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian 
aid7 

As regards Council Regulation (EC) No 1257/96, power should in particular be conferred on 
the Commission to adopt implementing Regulations for that Regulation. Since those measures 
are  of  general  scope  and  are  designed  to  supplement  Regulation  (EC)  No  1257/96  by  the 
addition  of  new  non-essential  elements,  they  must  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC 

Accordingly, Regulation (EC) No 1257/96 is amended as follows: 

(1) 

In Article 13, the fourth paragraph is replaced by the following: 

“Decisions  to  continue  operations  adopted  by  the  emergency  procedure  shall  be 
taken  by  the  Commission,  acting  in  accordance  with  the  procedure  laid  down  in 
Article 17(2) and within the limits set in the second indent of Article 15(2).” 

(2) 

Article 15 is replaced by the following: 

“Article 15  

1. 

The  Commission  shall  adopt  implementing  Regulations  for  this  Regulation. 
That measure, designed to amend non-essential elements of this Regulation by 
supplementing it, shall be adopted according to the regulatory procedure with 
scrutiny referred to in Article 17(4). 

2.  Acting  in  accordance  with  the  procedure  laid  down  in  Article  17(3),  the 

Commission shall: 

- 

- 

decide  on  Community  financing  for  the  humanitarian-aid  protection 
operations referred to in Article 2(c), 

decide  to  take  direct  Commission  action  or  finance  action  by  Member 
States' specialised agencies. 

3.  Acting  in  accordance  with  the  procedure  laid  down  in  Article  17(2),  the 

Commission shall: 

- 

approve global plans intended to provide a coherent framework for action 
in  a  given  country  or  region  where  the  scale  and  complexity  of  the 
humanitarian  crisis  is  such  that  it  seems  likely  to  continue,  and  the 
budgets for those plans. In this context, the Commission and the Member 

7 

OJ L 163, 2.7.1996, p. 1. 

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States shall examine the priorities to be established in the implementation 
of these global plans, 

- 

decide  on  projects  in  excess  of  ECU  2  million,  without  prejudice  to 
Article 13.” 

(3) 

Article 17 is replaced by the following: 

1. 

The Commission shall be assisted by a Committee. 

“Article 17 

2.  Where  reference  is  made  to  this  paragraph,  Articles  4  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The time limit laid down in Article 4(3) of Decision 1999/468/EC shall be one 
month. 

3.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The time limit laid down in Article 5(6) of Decision 1999/468/EC shall be one 
month. 

4.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

2. 

ENTERPRISE 

2.1. 

Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws 
of the Member States relating to aerosol dispensers8 

As regards Directive 75/324/EEC, power should in particular be conferred on the Commission 
to adopt the necessary technical adaptations to that Directive and the required amendments to 
adapt  the  Annex  to  technical  progress.  Since  those  measures  are  of  general  scope  and  are 
designed  to  amend  non-essential  elements  of  that  Directive,  they  must  be  adopted  in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 
1999/468/EC. 

Accordingly, Directive 75/324/EEC is amended as follows: 

(1) 

Article 5 is replaced by the following: 

8 

OJ L 147, 9.6.1975, p. 40. 

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“Article 5 

The  Commission  shall  adopt  the  amendments  required  to  adapt  the  Annex  to  this 
Directive  to  technical  progress.  Those  measures,  designed  to  amend  non-essential 
elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 7(2)”. 

(2) 

Article 7 is amended as follows: 

(a)  Paragraph 2 is replaced by the following: 

“2.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof”. 

(b)  Paragraph 3 is deleted. 

(3) 

In Article 10, paragraph 3 is replaced by the following: 

“3.  The Commission may adopt necessary technical adaptations of this Directive. 
Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 7(2).  

In  that  case,  the  Member  State  having  adopted  safeguard  measures  may 
maintain them until the entry into force of the adaptations.” 

2.2. 

Council  Directive  93/15/EEC  of  5  April  1993  on  the  harmonisation  of  the 
provisions  relating  to  the  placing  on  the  market  and  supervision  of  explosives 
for civil uses9 

As  regards  Directive  93/15/EEC,  powers  are  conferred  on  the  Commission  in  particular  to 
adapt  the  Directive  to  take  account  of  any  future  amendments  to  the  United  Nations 
recommendations and to set the conditions for the application of Article 14, second paragraph. 
Since those measures are of general scope and are designed to amend non-essential elements 
of  Directive  93/15/EEC,  they  must  be  adopted  in  accordance  with  the  regulatory  procedure 
with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 93/15/EEC is amended as follows: 

(1) 

Article 13 is replaced by the following: 

“Article 13 

The Commission shall be assisted by a committee.  

The  committee  shall  examine  any  matter  concerning  the  application  of  this 
Directive.  

1. 

2. 

9 

OJ L 121, 15.05.1993, p. 20. 

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3.  Where  reference  is  made  to  this  paragraph,  Articles  4  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.  

4.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.  

5. 

The  Commission  shall,  in  accordance  with  the  procedure  referred  to  in 
paragraph 3, adopt implementing measures in particular to take account of any 
future amendments to the United Nations recommendations.”  

(2) 

The second paragraph of Article 14 is replaced by the following: 

“Member  States  shall  ascertain  whether  such  undertakings  possess  a  system  for 
keeping  track  of  explosives  such  that  those  holding  explosives  can  be  identified  at 
any  time.  The  Commission  may  adopt  measures  setting  the  conditions  for  the 
application  of  this  paragraph.  Those  measures,  designed  to  amend  non-essential 
elements of this Directive by supplementing it, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 13(4).” 

2.3. 

Directive 2000/14/EC of the European Parliament and of the Council of 8 May 
2000  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  the 
noise emission in the environment by equipment for use outdoors10 

As regards Directive 2000/14/EC, power should in particular be conferred on the Commission 
to  establish  the  conditions  under  which  amendments  which  are  necessary,  in  the  light  of 
adaptation to technical progress, should be adopted. Since those measures are of general scope 
and are designed to amend non-essential elements of that Directive, they must be adopted in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 
1999/468/EC. 

Accordingly, Directive 2000/14/EC is amended as follows: 

(1) 

Article 18 is amended as follows: 

(a) 

paragraph 2 is replaced by the following: 

“2.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

(b)  paragraph 3 is deleted. 

(2) 

The following Article 18a is inserted: 

10 

OJ L 162, 3.7.2000, p.1. 

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“Article 18a 

The Commission shall adopt implementing measures for the adaptation to technical 
progress of Annex III, provided they do not have any direct impact on the measured 
sound  power  level  of  equipment  listed  in  Article  12,  in  particular  through  the 
inclusion of references to relevant European standards. 

Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 18(2).” 

(3) 

In Article 19, point (b) is replaced by the following: 

“(b)  assist the Commission in the adaptation to technical progress of Annex III”. 

2.4. 

Regulation (EC) No 2003/2003 of the European Parliament and of the Council 
of 13 October 2003 relating to fertilisers11 

As  regards  Regulation  (EC)  No  2003/2003,  power  should  in  particular  be  conferred  on  the 
Commission to adapt its annexes to technical progress, to adapt the measuring, sampling and 
analysis methods, to adopt rules regarding control measures and to include new types of EC 
fertilisers. Since those measures are of general scope and are designed to amend non-essential 
elements  of  Regulation  (EC)  No  2003/2003,  they  must  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 2003/2003 is amended as follows: 

(1) 

In Article 29, paragraph 4 is replaced by the following: 

“4.  The  Commission  shall  adapt  and  modernise  the  measuring,  sampling  and 
analysis methods and shall, wherever possible, use European Standards. Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  shall 
be adopted in accordance with the regulatory procedure with scrutiny referred 
to  in  Article  32(3).  The  same  procedure  shall  apply  to  the  adoption  of 
implementing rules needed to specify the control measures provided for in this 
Article and in Articles 8, 26 and 27. Such rules shall in particular address the 
question  of  the  frequency  with  which  tests  need  to  be  repeated,  as  well  as 
measures  that  are  designed  to  ensure  that  the  fertiliser  put  on  the  market  is 
identical with the fertiliser tested.”  

(2) 

Article 31 is amended as follows: 

(a)  Paragraph 1 is replaced by the following: 

“1.  The Commission shall adapt Annex I to include new types of fertilisers.” 

(b)  Paragraph 3 is replaced by the following: 

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OJ L 304, 21.11.2003, p. 1. 

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“3.  The  Commission  shall  adapt  the  Annexes  to  take  account  of  technical 

progress.”  

(c)  The following paragraph 4 is added: 

“4.  The measures referred to in paragraphs 1 and 3, designed to amend non-
essential elements of this Regulation, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 32(3).” 

(3) 

Article 32 is replaced by the following: 

“Article 32 

Committee procedure 

1. 

The Commission shall be assisted by a Committee. 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months. 

3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

2.5. 

Directive  2004/9/EC  of  the  European  Parliament  and  of  the  Council  of 
11 February 2004 on the inspection and verification of good laboratory practice 
(GLP) (codified version)12 

As regards Directive 2004/9/EC, power should in particular be conferred on the Commission 
to  adapt  Annex  I  to  technical  progress  and  change  the  formula  in  Article  2(2).  Since  those 
measures are of general scope and are designed to amend non-essential elements of Directive 
2004/9/EC, they must be adopted in accordance with the regulatory procedure with scrutiny 
provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 2004/9/EC is amended as follows: 

(1) 

Article 7 is replaced by the following: 

“Article 7 

1. 

The  Commission  shall  be  assisted  by  the  Committee  established  by 
Article 29(1) of Directive 67/548/EEC(*), hereinafter “the Committee”. 

12 

OJ L 50, 20.2.2004, p. 28. 

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2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months. 

3  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

_____________________ 

(*)  OJ 196, 16.8.1967, p. 1, as amended by Council Regulation (EC) No 807/2003 

of 14 April 2003, OJ L 122, 16.5.2003" 

(2) 

In Article 8, paragraph 2 is replaced by the following: 

“2.  The Commission shall adopt implementing measures for the following: 

(a) 

adaptation of the formula referred to in Article 2(2); 

(b) 

the adaptation of Annex I to take account of technical progress. 

Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 7(3).” 

2.6. 

Directive  2004/10/EC  of  the  European  Parliament  and  of  the  Council  of 
11 February 2004 on the harmonisation of laws, regulations and administrative 
provisions  relating  to  the  application  of  the  principles  of  good  laboratory 
practice  and  the  verification  of  their  applications  for  tests  on  chemical 
substances (codified version)13 

As regards Directive 2004/10/EC, power should in particular be conferred on the Commission 
to adapt the Annex to technical progress. Since those measures are of general scope and are 
designed to amend non-essential elements of Directive 2004/10/EC, they must be adopted in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 
1999/468/EC. 

Accordingly, Directive 2004/10/EC is amended as follows: 

(1) 

The following Article 3a is inserted: 

“Article 3a 

The  Commission  may  adapt  the  Annex  to  technical  progress,  with  regard  to 
principles of GLP. 

13 

OJ L 50, 20.2.2004, p. 44. 

EN 

14 

   EN 

 
 
                                                 
Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 4(2).” 

(2) 

Article 4 is replaced by the following: 

“Article 4 

1. 

The  Commission  shall  be  assisted  by  the  Committee  established  by 
Article 29(1) of Directive 67/548/EEC(*). 

2.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

_____________________ 

(*)  OJ 196, 16.8.1967, p. 1, as amended by Council Regulation (EC) No 807/2003 

of 14 April 2003, OJ L 122, 16.5.2003." 

(3) 

In Article 5(2) the third subparagraph is replaced by the following:  

“The  Commission  may  adopt  implementing  measures  to  introduce  necessary 
technical adaptations of this Directive. 

Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 4(2). 

In the case referred to in the third subparagraph the Member State which adopted the 
safeguard  measures  may  maintain  them  until  the  entry  into  force  of  those 
adaptations.” 

2.7. 

Regulation (EC) No 273/2004 of the European Parliament and of the Council of 
11 February 2004 on drug precursors14 

As  regards  Regulation  (EC)  No  273/2004,  power  should  in  particular  be  conferred  on  the 
Commission  to  adopt  measures  for  the  implementation  of  the  Regulation.  Since  those 
measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of 
Regulation  (EC)  No  273/2004,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 273/2004 is amended as follows: 

(1) 

Article 14 is amended as follows: 

(a) 

the introductory sentence is replaced by the following: 

14 

OJ L 47, 18.2.2004, p. 1. 

EN 

15 

   EN 

 
                                                 
“Where necessary, the Commission shall adopt implementation measures concerning 
the following:” 

(b) 

the following second and third paragraphs are added: 

“The  measures  referred  to  in  points  (a)  to  (e)  of  the  first  paragraph,  designed  to 
amend non-essential elements of this Regulation, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 15(3). 

The  measures  referred  to  in  point  (f)  of  the  first  paragraph  shall  be  adopted  in 
accordance with the procedure referred to in Article 15(2)” 

(2) 

Article 15 is replaced by the following: 

“Article 15 

Committee  

1. 

The  Commission  shall  be  assisted  by  the  Committee  set  up  in  Article  30  of 
Council Regulation (EC) No 111/2005(*). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  4  and  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 
The  time  limit  laid  down  in  Article  4(3)  of  Decision  1999/468/EC  shall  be 
three months. 

3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

_______________________ 

(*) OJ L 22, 26.1.2005, p. 1.” 

2.8. 

Regulation (EC) No 648/2004 of the European Parliament and of the Council of 
31 March 2004 on detergents15 

As  regards  Regulation  (EC)  No  648/2004,  power  should  in  particular  be  conferred  on  the 
Commission  to  adapt  its  annexes  and  to  adopt  any  amendments  or  additions  necessary  for 
applying  the  rules  of  this  Regulation  to  solvent-based  detergents,  where  necessary.  Since 
those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of 
Regulation  (EC)  No  648/2004,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 648/2004 is amended as follows: 

(1) 

Article 12 is replaced by the following: 

15 

OJ L 104, 8.4.2004, p.1. 

EN 

16 

   EN 

 
                                                 
“Article 12 

Committee procedure 

1. 

The Commission shall be assisted by a Committee. 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months. 

3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

(2) 

Article 13 is replaced by the following: 

“Article 13 

Adaptation of the Annexes 

1. 

2. 

3. 

The  Commission  shall  adopt  any  amendments  necessary  for  adapting  the 
Annexes and shall, wherever possible, use European Standards.  

The  Commission  shall  adopt  any  amendments  or  additions  necessary  for 
applying the rules of this Regulation to solvent-based detergents. 

The  measures  referred  to  in  paragraphs  1  and  2,  designed  to  amend  non-
essential elements of this Regulation, shall be adopted in accordance with the 
regulatory procedure with scrutiny referred to in Article 12(3).” 

(3) 

In Annex VII, point A, the antepenultimate paragraph is replaced by the following: 

“If  individual  risk-based  concentration  limits  for  the  fragrance  allergens  are 
subsequently  established  by  the  SCCNFP,  the  Commission  shall  propose  the 
adoption  of  such  limits  to  replace  the  limit  of  0.01%  mentioned  above.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  shall  be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 12(3).” 

EN 

17 

   EN 

 
2.9. 

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 
31  March  2004  laying  down  Community  procedures  for  the  authorisation  and 
supervision  of  medicinal  products  for  human  and  veterinary  use  and 
establishing a European Medicines Agency16 

As  regards  Regulation  (EC)  No  726/2004,  power  should  in  particular  be  conferred  on  the 
Commission  to  adapt  certain  provisions  and  annexes,  to  adopt  arrangements  and  principles 
and guidelines, and to lay down specific conditions of application. Since those measures are 
of  general  scope  and  are  designed  to  amend  non-essential  elements  of  Regulation  (EC)  No 
726/2004 and/or to supplement this Regulation by the addition of new non-essential elements, 
they must be adopted in accordance with the regulatory procedure with scrutiny provided for 
in Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 726/2004 is amended as follows:  

(1) 

In Article 3, paragraph 4 is replaced by the following:  

“4.  After  the  competent  committee  of  the  Agency  has  been  consulted,  the 
Commission may re-examine the Annex in the light of technical and scientific 
progress  and  may  adopt  any  necessary  amendments  without  extending  the 
scope of the centralised procedure. 

Those measures, designed to amend non-essential elements of this Regulation, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 87(2a).” 

(2) 

In Article 14(7), the third subparagraph is replaced by the following:  

“The Commission shall adopt a Regulation laying down provisions for granting such 
authorisation.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Regulation by supplementing it, shall be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 87(2a).” 

(3) 

In Article 16, paragraph 4 is replaced by the following:  

“4.  The  Commission  shall,  after  consulting  the  Agency,  adopt  appropriate 
provisions for the examination of variations to marketing authorisations in the 
form  of  a  regulation.  Those  measures,  designed  to  amend  non-essential 
elements  of  this  Regulation  by  supplementing  it,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
87(2a).” 

(4) 

Article 24 is amended as follows: 

(a) 

in paragraph 2, the first subparagraph is replaced by the following: 

“The  holder  of  the  marketing  authorisation  for  a  medicinal  product  for  human  use 
shall  ensure  that  all  suspected  serious  unexpected  adverse  reactions  and  any 
suspected transmission via a medicinal product of any infectious agent occurring in 

16 

OJ L 136, 30. 4.2004, p. 1.  

EN 

18 

   EN 

 
                                                 
the  territory  of  a  third  country  are  reported  promptly  to  Member  States  and  the 
Agency,  and  no  later  than  15  days  following  receipt  of  the  information.  The 
Commission shall adopt provisions for the reporting of suspected unexpected adverse 
reactions  which  are  not  serious,  whether  occurring  in  the  Community  or  in  a  third 
country.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
regulation  by  supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 87(2a).” 

(b)  paragraph 4 is replaced by the following:  

“4.  The  Commission  may  lay  down  provisions  to  amend  paragraph  3  in  view  of 
experience gained with its operation. Those measures, designed to amend non-
essential  elements  of  this  regulation,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 87(2a).” 

(5) 

Article 29 is replaced by the following: 

“Article 29 

The Commission may adopt any amendment which may be necessary to update the 
provisions  of  this  Chapter  in  order  to  take  account  of  scientific  and  technical 
progress.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
regulation,  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 87(2a).” 

(6) 

In Article 41, paragraph 6 is replaced by the following: 

“6.  The  Commission  shall,  after  consulting  the  Agency,  adopt  appropriate 
provisions for the examination of variations to marketing authorisations in the 
form  of  a  regulation.  Those  measures,  designed  to  amend  non-essential 
elements of this regulation by supplementing it, shall be adopted in accordance 
with the regulatory procedure with scrutiny referred to in Article 87(2a).” 

(7) 

Article 49 is amended as follows:  

(a) 

in paragraph 2 the first subparagraph is replaced by the following: 

“The holder of the marketing authorisation for a veterinary medicinal product shall 
ensure  that  all  suspected  serious  unexpected  adverse  reactions,  and  adverse  human 
reactions, and any suspected transmission via a medicinal product of any infectious 
agent  occurring  in  the  territory  of  a  third  country  are  reported  promptly  to  the 
Member  States  and  the  Agency,  and  no  later  than  15  days  following  receipt  of  the 
information.  The  Commission  shall  adopt  provisions  for  the  reporting  of  suspected 
unexpected  adverse  reactions  which  are  not  serious,  whether  occurring  in  the 
Community or in a third country. Those measures, designed to amend non-essential 
elements of this regulation by supplementing it, shall be adopted in accordance with 
the procedure referred to in Article 87(2a).” 

EN 

19 

   EN 

 
(b)  paragraph 4 is replaced by the following: 

“The  Commission  may  lay  down  provisions  to  amend  paragraph  3  in  view  of 
experience  gained  with  its  operation.  Those  measures,  designed  to  amend  non-
essential  elements  of  this  regulation,  shall  be  adopted  in  accordance  with  the 
procedure referred to in Article 87(2a).” 

(8) 

Article 54 is replaced by the following: 

“Article 54 

The Commission may adopt any amendment which may be necessary to update the 
provisions  of  this  Chapter  in  order  to  take  account  of  scientific  and  technical 
progress.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
regulation,  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 87(2a).” 

(9) 

In Article 70, paragraph 2 is replaced by the following: 

“2.  However, 

the  Commission 

shall  adopt  provisions  establishing 

the 
circumstances in which small and medium-sized enterprises may pay reduced 
fees,  defer  payment  of  the  fee,  or  receive  administrative  assistance.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 87(2a).” 

(10) 

In Article 84(3), the first subparagraph is replaced by the following: 

“At  the  Agency’s  request,  the  Commission  may  impose  financial  penalties  on  the 
holders  of  marketing  authorisations  granted  under  this  Regulation  if  they  fail  to 
observe  certain  obligations  laid  down  in  connection  with  the  authorisations.  The 
maximum  amounts  as  well  as  the  conditions  and  methods  for  collection  of  these 
penalties shall be laid down by the Commission. Those measures, designed to amend 
non-essential  elements  of  this  Regulation  by  supplementing  it,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).”  

(11) 

Article 87 is amended as follows: 

a) 

The following paragraph 2a is inserted: 

“2a.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof”.  

b) 

Paragraph 4 is deleted. 

EN 

20 

   EN 

 
3. 

ENVIRONMENT 

3.1. 

Council  Directive  82/883/EEC  of  3  December  1982  on  procedures  for  the 
surveillance  and  monitoring  of  environments  concerned  by  waste  from  the 
titanium dioxide industry17  

As regards Directive 82/883/EEC, power should in particular be conferred on the Commission 
to  adapt  the  contents  of  the  Annexes  as  regards  parameters  listed  in  the  ‘optional 
determination’  column  and  reference  methods  of  measurement  to  scientific  and  technical 
progress. Since those measures are of general scope and are designed to amend non-essential 
elements  of  Directive  82/883/EEC,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 82/883/EEC is amended as follows: 

(1) 

Article 9 is replaced by the following: 

“Article 9 

The  Commission  shall  adopt  the  requisite  amendments  to  adapt  to  scientific  and 
technical  progress  the  contents  of  the  Annexes  as  regards  parameters  listed  in  the 
'optional determination' column and reference methods of measurement. 

Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 11(2).” 

(2) 

Article 11 is replaced by the following:  

“Article 11 

1. 

The Commission shall be assisted by the committee on adaptation to technical 
progress. 

2.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

3.2. 

Council  Directive  86/278/EEC  of  12  June  1986  on  the  protection  of  the 
environment,  and  in  particular  of  the  soil,  when  sewage  sludge  is  used  in 
agriculture18 

As regards Directive 86/278/EEC, power should in particular be conferred on the Commission 
to adapt to technical and scientific progress provisions of the Annexes. Since those measures 
are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of  Directive 
86/278/EEC, they must be adopted in accordance with the regulatory procedure with scrutiny 
provided for in Article 5a of Decision 1999/468/EC. 

17 
18 

OJ L 378, 31.12.1982, p. 1. 
OJ L 181, 4.7.1986, p. 6. 

EN 

21 

   EN 

 
                                                 
Accordingly, Directive 86/278/EEC is amended as follows: 

(1) 

Article 13 is replaced by the following: 

“Article 13 

The Commission shall adapt to technical and scientific progress the provisions of the 
Annexes to the Directive, except for the parameters and values listed in Annexes I A, 
I  B  and  I  C,  any  factors  likely  to  affect  the  evaluation  of  the  values,  and  the 
parameters for analysis referred to in Annexes II A and II B. 

Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 15(2).” 

(2) 

Article 15 is replaced by the following: 

“Article 15 

1. The Commission shall be assisted by the Committee for adapting this Directive to 
technical and scientific progress. 

2. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof.” 

3.3. 

European Parliament and Council Directive 94/62/EC of 20 December 1994 on 
packaging and packaging waste19  

As regards Directive 94/62/EC, power should in particular be conferred on the Commission to 
examine  and,  where  necessary,  review  the  illustrative  examples  for  the  definition  of 
packaging and to determine the conditions under which concentration levels of heavy metals 
present in packaging or packaging components will not apply to some materials and product 
loops, the types of packaging exempted from the requirement regarding concentration levels 
and the technical measures necessary to deal with any difficulties encountered in applying the 
provisions  of  this  Directive.  Since  those  measures  are  of  general  scope  and  are  designed  to 
amend  non-essential  elements  of  Directive  94/62/EC  or  to  supplement  that  Directive  by  the 
addition  of  new  non-essential  elements,  they  must  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 94/62/EC is amended as follows: 

(1) 

In Article 3(1), the fourth subparagraph is replaced by the following: 

“The  Commission  shall,  as  appropriate,  examine  and,  where  necessary,  review  the 
illustrative examples for the definition of packaging given in Annex I. As a priority, 
the following items shall be addressed: CD and video cases, flower pots, tubes and 

19 

OJ L 365, 31.12.1994, p. 10. 

EN 

22 

   EN 

 
                                                 
cylinders  around  which  flexible  material  is  wound,  release  paper  of  self-adhesive 
labels  and  wrapping  paper.  Those  measures,  designed  to  amend  non-essential 
elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 21(3)." 

(2) 

In Article 11, paragraph 3 is replaced by the following: 

“3.  The Commission shall determine the conditions under which the concentration 
levels  referred  to  in  paragraph  1  will  not  apply  to  recycled  materials  and  to 
product loops which are in a closed and controlled chain, as well as the types of 
packaging which are exempted from the requirement referred to in paragraph 1, 
third indent. 

Those measures, designed to amend non-essential elements of this Directive by 
supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 21(3)." 

(3) 

In Article 12, paragraph 3 is replaced by the following: 

“3. 

In order to harmonise the characteristics and presentation of the data produced 
and  to  make  the  data  of  the  Member  States  compatible,  Member  States  shall 
provide the Commission with their available data by means of formats which 
shall be adopted on the basis of Annex III, in accordance with the regulatory 
procedure referred to in Article 21(2).” 

(4) 

Article 19 is replaced by the following:  

“Article 19 

Adaptation to scientific and technical progress 

(a)  The amendments necessary for adapting to scientific and technical progress the 
identification  system  (as  referred  to  in  Article  8(2)  and  Article  10,  second 
paragraph,  last  indent),  and  the  formats  relating  to  the  database  system  (as 
referred to in Article 12(3) and Annex III) shall be adopted in accordance with 
the regulatory procedure referred to in Article 21(2). 

(b)  The  Commission  shall  adopt  the  amendments  necessary  for  adapting  to 
scientific  and  technical  progress  the  illustrative  examples  on  the  definition  of 
packaging (as referred to in Annex I). Those measures, designed to amend non-
essential  elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 21(3).”  

(5) 

In Article 20, paragraph 1 is replaced by the following: 

“1.  The Commission shall determine technical measures necessary to deal with any 
difficulties  encountered  in  applying  the  provisions  of  this  Directive  in 
particular  to  inert  packaging  materials,  put  on  the  market  in  very  small 
quantities  (i.e.  approximately  0.1%  by  weight)  in  the  Community,  primary 
packaging  for  medical  devices  and  pharmaceutical  products,  small  packaging 

EN 

23 

   EN 

 
and  luxury  packaging.  Those  measures,  designed  to  amend  non-essential 
elements of this Directive by supplementing it, shall be adopted in accordance 
with the regulatory procedure with scrutiny referred to in Article 21(3).” 

(6) 

In Article 21, paragraph 3 is replaced by the following: 

“3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

3.4. 

Council  Directive  1999/32/EC  of  26  April  1999  relating  to  a  reduction  in  the 
sulphur content of certain liquid fuels and amending Directive 93/12/EEC20 

As regards Directive 1999/32/EC, power should in particular be conferred on the Commission 
to  establish  criteria  for  the  use  of  emission  abatement  technologies  by  ships  of  all  flags  in 
enclosed ports, harbours and estuaries in the Community and to adopt amendments necessary 
to  make  technical  adaptations  to  some  provisions  in  the  light  of  scientific  and  technical 
progress. Since those measures are of general scope and are designed to amend non-essential 
elements of Directive 1999/32/EC or to supplement that Directive by the addition of new non-
essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 1999/32/EC is amended as follows:  

(1) 

In Article 4c, paragraph 3 is replaced by the following:  

“3.  Criteria  shall  be  established  by  the  Commission  for  the  use  of  emission 
abatement  technologies  by  ships  of  all  flags  in  enclosed  ports,  harbours  and 
estuaries in the Community. Those measures, designed to amend non-essential 
elements of this Directive by supplementing it, shall be adopted in accordance 
with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article  9(2).  The 
Commission shall communicate these criteria to the IMO.” 

(2) 

In Article 7, paragraph 4 is replaced by the following:  

“4.  Any amendments necessary to make technical adaptations to Article 2, points 
1,  2,  3,  3a,  3b  and  4,  or  Article  6(2)  in  the  light  of  scientific  and  technical 
progress  shall  be  adopted  by  the  Commission.  Those  measures,  designed  to 
amend non-essential elements of this Directive, shall be adopted in accordance 
with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article  9(2).  Such 
adaptations shall not result in any direct changes to the scope of this Directive 
or to limits on sulphur in fuel specified in this Directive.” 

(3) 

Article 9 is replaced by the following:  

20 

OJ L 121, 11.5.1999, p. 13. 

EN 

24 

   EN 

 
                                                 
“Article 9 

Committee 

1. 

The Commission shall be assisted by a committee. 

2.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

3.5. 

Directive  2001/81/EC  of  the  European  Parliament  and  of  the  Council  of 
23 October  2001  on  national  emission  ceilings  for  certain  atmospheric 
pollutants21 

As regards Directive 2001/81/EC, power should in particular be conferred on the Commission 
to update the methodologies to be used in accordance with Annex III. Since those measures 
are of general scope and are designed to amend non-essential elements of that Directive, inter 
alia by supplementing it, they must be adopted in accordance with the regulatory procedure 
with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 2001/81/EC is amended as follows: 

(1) 

In Article 7, paragraph 4 is replaced by the following: 

“4.  Any  updating of the methodologies to be used in accordance with Annex III, 
shall be adopted by the Commission. Those measures, designed to amend non-
essential  elements  of  this  Directive,  inter  alia  by  supplementing  it,  shall  be 
adopted in accordance with the regulatory procedure with scrutiny referred to 
in Article 13(3).” 

(2) 

In Article 13, paragraph 3 is replaced by the following: 

“3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

3.6. 

Directive  2003/87/EC  of  the  European  Parliament  and  of  the  Council  of 
13 October  2003  establishing  a  scheme  for  greenhouse  gas  emission  allowance 
trading within the Community and amending Council Directive 96/61/EC22 

As regards Directive 2003/87/EC, power should in particular be conferred on the Commission 
to adopt provisions necessary for the implementation of Article 11b(5), to adopt a Regulation 
for  a  standardised  and  secured  system  of  registries  including  provisions  concerning  the  use 
and  identification  of  CERs  and  ERUs  in  the  Community  scheme  and  the  monitoring  of  the 
level  of  such  use,  to  amend  Annex  III  as  laid  down  in  Article  22,  to  approve  inclusion  of 
activities  and  greenhouse  gases  not  listed  in  Annex  I,  to  draw  up  any  necessary  provisions 
relating to the mutual recognition of allowances under agreements with third countries, and to 

21 
22 

OJ L 309, 27.11.2001, p. 22. 
OJ L 275, 25.10.2003, p. 32. 

EN 

25 

   EN 

 
                                                 
adopt  standardised  or  accepted  measures  for  monitoring  of  emissions  of  other  greenhouse 
gases.  Since  those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential 
elements of Directive 2003/87/EC or to supplement that Directive by the addition of new non-
essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 2003/87/EC is amended as follows: 

(1) 

In Article 11b, paragraph 7 is replaced by the following: 

“7.  Provisions for the implementation of paragraphs 3 and 4, particularly in respect 
of  the  avoidance  of  double  counting,  shall  be  adopted  by  the  Commission  in 
accordance  with  the  regulatory  procedure  referred  to  in  Article 23(2).  The 
Commission  shall  adopt  provisions  for  the  implementation  of  paragraph  5 
where the host party meets all eligibility requirements for JI project activities. 
Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive, 
by  supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 23(3).” 

(2) 

In Article 19, paragraph 3 is replaced by the following: 

“3. 

In order to implement this Directive, the Commission shall adopt a Regulation 
for a standardised and secured system of registries in the form of standardised 
electronic  databases  containing  common  data  elements  to  track  the  issue, 
holding,  transfer  and  cancellation  of  allowances,  to  provide  for  public  access 
and  confidentiality  as  appropriate  and  to  ensure  that  there  are  no  transfers 
incompatible  with  obligations  resulting  from  the  Kyoto  Protocol.  That 
Regulation shall also include  provisions concerning the use and identification 
of CERs and ERUs in the Community scheme and the monitoring of the level 
of  such  use.  That  measure,  designed  to  amend  non-essential  elements  of  this 
Directive  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 23(3).” 

(3) 

Article 22 is replaced by the following : 

“Article 22 

Amendments to Annex III 

The  Commission  may  amend  Annex  III,  with  the  exception  of  criteria  (1),  (5)  and 
(7),  for  the  period  from  2008  to  2012  in  the  light  of  the  reports  provided  for  in 
Article 21 and of the experience of the application of this Directive. Those measures, 
designed  to  amend  non-essential  elements  of  this  Directive,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 23(3).”  

(4) 

In Article 23, paragraph 3 is replaced by the following: 

“3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof." 

EN 

26 

   EN 

 
(5) 

In Article 24, paragraph 1 is replaced by the following: 

“1.  Taking  into  account  all  relevant  criteria,  in  particular  effects  on  the  internal 
market, potential distortions of competition, the environmental integrity of the 
scheme  and  reliability  of  the  planned  monitoring  and  reporting  system, 
Member States may from 2008 apply emission allowance trading in accordance 
with this Directive to: 

a) 

b) 

installations  which  are  not  listed  in  Annex  I,  provided  that  inclusion  of 
such installations is approved by the Commission in accordance with the 
procedure referred to in Article 23(2), and 

activities and greenhouse gases which are not listed in Annex I, provided 
that inclusion of such activities and greenhouse gases is approved by the 
Commission. That measure, designed to amend non-essential elements of 
this  Directive  by  supplementing  it,  shall  be  adopted  in  accordance  with 
the regulatory procedure with scrutiny referred to in Article 23(3). 

From  2005  Member  States  may  under  the  same  conditions  apply  emissions 
allowance trading to installations carrying out activities listed in Annex I below 
the capacity limits referred to in that Annex.” 

(6) 

In Article 25, paragraph 2 is replaced by the following:  

“2.  Where  an  agreement  referred  to  in  paragraph  1  has  been  concluded,  the 
Commission  shall  adopt  any  necessary  provisions  relating  to  the  mutual 
recognition of allowances under that agreement. Those  measures, designed to 
amend  non-essential  elements  of  this  Directive  by  supplementing  it,  shall  be 
adopted in accordance with the regulatory procedure with scrutiny referred to 
in Article 23(3).” 

(7) 

In  Annex  IV,  the  paragraph  under  the  heading  “Monitoring  of  emissions  of  other 
greenhouse gases” is replaced by the following: 

“Standardised  or  accepted  methods  shall  be used, developed by the Commission in 
collaboration  with  all  relevant  stakeholders.  Those  measures,  designed  to  amend 
non-essential  elements  of  this  Directive  by  supplementing  it,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 23(3).” 

3.7. 

Regulation (EC) No 850/2004 of the European Parliament and of the Council of 
29  April  2004  on  persistent  organic  pollutants  and  amending  Directive 
79/117/EEC23 

As  regards  Regulation  (EC)  No  850/2004,  power  should  in  particular  be  conferred  on  the 
Commission to specify some concentration limits in the annexes, to amend annexes whenever 
a substance is listed in the Convention or the Protocol, to modify the existing entries and to 
adapt annexes to scientific and technical progress. Since those measures are of general scope 
and  are  designed  to  amend  non-essential  elements  of  Regulation  (EC)  No  850/2004,  they 

23 

OJ L 158, 30.4.2004, p. 7. 

EN 

27 

   EN 

 
                                                 
must  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  provided  for  in 
Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 850/2004 is amended as follows: 

(1) 

Article 7 is amended as follows: 

(a) 

In paragraph 4, point (a) is replaced by the following: 

“(a)  waste containing or contaminated by any substance listed in Annex IV may be 
otherwise disposed of or recovered in accordance with the relevant Community 
legislation,  provided  that  the  content  of  the  listed  substances  in  the  waste  is 
below  the  concentration  limits  to  be  specified  in  Annex  IV.  Those  measures, 
designed to amend non-essential elements of this Regulation, shall be adopted 
in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 17(3).  Until  such  time  as  concentration  limits  are  specified  in 
accordance  with  such  procedure,  the  competent  authority  of  a  Member  State 
may  adopt  or  apply  concentration  limits  or  specific  technical  requirements  in 
respect of the disposal or recovery of waste under this subparagraph;” 

(b) 

In paragraph 5, the first subparagraph is replaced by the following: 

“Concentration limits in Annex V, part 2 shall be established by the Commission for 
the  purposes  of  paragraph  4(b)  of  this  Article.  Those  measures,  designed  to  amend 
non-essential  elements  of  this  Regulation,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 17(3)” 

(2) 

Article 14 is replaced by the following: 

“Article 14 

Amendment of Annexes 

1.  Whenever  a  substance  is  listed  in  the  Convention  or  the  Protocol,  the 
Commission shall amend Annexes I, II and III accordingly where appropriate.  

Those measures, designed to amend non-essential elements of this Regulation, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 16(3). 

2.  Whenever  a  substance  is  listed  in  the  Convention  or  the  Protocol,  the 

Commission shall amend Annex IV accordingly where appropriate.  

Those measures, designed to amend non-essential elements of this Regulation, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 17(3). 

3. 

The Commission shall adopt modifications to the existing entries in Annexes I 
to III, including their adaptation to scientific and technical progress.  

EN 

28 

   EN 

 
Those measures, designed to amend non-essential elements of this Regulation, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 16(3). 

4. 

The Commission shall adopt modifications to the existing entries in Annex IV 
and  modifications  to  Annex  V,  including  their  adaptation  to  scientific  and 
technical progress.  

Those measures, designed to amend non-essential elements of this Regulation, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 17(3).” 

(3) 

Article 16 is amended as follows: 

(a)  Paragraph 1 is replaced by the following: 

“1.  The Commission shall be assisted by the Committee established by Article 29 
of  Council  Directive  67/548/EEC(*)  for  all  matters  under  this  Regulation 
except for those relating to waste. 

____________________________ 

(*) OJ 196, 16.8.1967, p. 1, as amended by Council Regulation (EC) No 807/2003 of 
14 April 2003, OJ L 122, 16.5.2003.” 

(b)  paragraph 3 is replaced by the following: 

“3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

(4) 

In Article 17, paragraph 3 is replaced by the following : 

“3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.”  

3.8. 

Directive  2004/107/EC  of  the  European  Parliament  and  of  the  Council  of 
15 December 2004 relating to arsenic, cadmium, mercury, nickel and polycyclic 
aromatic hydrocarbons in ambient air24 

As  regards  Directive  2004/107/EC,  power  should  in  particular  be  conferred  on  the 
Commission  to  adapt  certain  provisions  and  Annexes  to  scientific  and  technical  progress. 
Since those measures are of general scope and are designed to amend non-essential elements 
of Directive 2004/107/EC, they must be adopted in accordance with the regulatory procedure 
with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 2004/107/EC is amended as follows: 

24 

OJ L 23, 26.1.2005, p. 3. 

EN 

29 

   EN 

 
                                                 
(1) 

Article 4 is amended as follows: 

(a)  Paragraph 9 is replaced by the following: 

“9. 

Irrespective  of  concentration  levels,  one  background  sampling  point  shall  be 
installed every 100000 km2 for the indicative measurement, in ambient air, of 
arsenic, cadmium, nickel, total gaseous mercury, benzo(a)pyrene and the other 
polycyclic  aromatic  hydrocarbons  referred  to  in  paragraph  8  and  of  the  total 
deposition of arsenic, cadmium, mercury, nickel, benzo(a)pyrene and the other 
polycyclic  aromatic  hydrocarbons  referred  to  in  paragraph  8.  Each  Member 
State shall set up at least one measuring station; however, Member States may, 
by  agreement,  and  in  accordance  with  guidelines  to  be  drawn  up  under  the 
procedure referred to in Article 6(2), set up one or several common measuring 
stations, covering neighbouring zones in adjoining Member States, to achieve 
the  necessary  spatial  resolution.  Measurement  of  particulate  and  gaseous 
divalent mercury is also recommended. Where appropriate, monitoring shall be 
coordinated  with  the  European  Monitoring  and  Evaluation  of  Pollutants 
(EMEP) monitoring strategy and measurement programme. The sampling sites 
for these pollutants shall be selected in such a way that geographical variation 
and long-term trends can be identified. Sections I, II and III of Annex III shall 
apply.” 

(b)  Paragraph 15 is replaced by the following: 

“15.  Any  amendments  necessary  to  adapt  the  provisions  of  this  Article  and  of 
Section II of Annex II and of Annexes III, IV and V to scientific and technical 
progress  shall  be  adopted  by  the  Commission.  Those  measures,  designed  to 
amend non-essential elements of this Directive, shall be adopted in accordance 
with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article  6(3).  They 
may not result in any direct or indirect changes to target values.” 

(2) 

In Article 5, paragraph 4 is replaced by the following: 

“4.  The  Commission  shall  adopt,  in  accordance  with  the  procedure  referred  to  in 
Article  6(2),  any  detailed  arrangements  for  forwarding  the  information  to  be 
provided under paragraph 1 of this Article.” 

(3) 

In Article 6, paragraph 3 is replaced by the following: 

“3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

(4) 

Annex V, point V is replaced by the following: 

“V. Reference air quality modelling techniques 

Reference  air  quality  modelling  techniques  cannot  be  specified  at  present.  The 
Commission  may  make  amendments  to  adapt  this  point  to  scientific  and  technical 
progress.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Directive, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 6(3).” 

EN 

30 

   EN 

 
3.9. 

Regulation (EC) No 1013/2006 of the European Parliament and of the Council 
of 14 June 2006 on shipments of waste25 

As  regards  Regulation  (EC)  No  1013/2006,  power  should  in  particular  be  conferred  on  the 
Commission to determine an issue as described in Article 11(3) of Regulation 1013/2006, to 
amend  the  annexes  as  laid  down  in  Article  58  of  Regulation  1013/2006  and  to  adopt 
additional  measures  as  laid  down  in  Article  59  of  Regulation  1013/2006.  Since  those 
measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of 
Regulation  (EC)  No  1013/2006  or  to  supplement  Regulation  (EC)  No  1013/2006  by  the 
addition  of  new  non-essential  elements,  they  must  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 1013/2006 is amended as follows: 

(1) 

In Article 11(3), the third subparagraph is replaced by the following: 

“If there is no satisfactory solution, either Member State may refer the matter to the 
Commission.  The  issue  shall  then  be  determined  in  accordance  with  the  regulatory 
procedure referred to in Article 59a(2)." 

(2) 

Article 58 is replaced by the following:  

“Article 58 

1. 

The  Commission  may  amend  the  Annexes  to  take  account  of  scientific  and 
technical progress. Those measures, designed to amend non-essential elements 
of  this  Regulation,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 59a(3). In addition: 

(a)  Annexes  I,  II,  III,  IIIA,  IV  and  V  shall  be  amended  to  take  account  of 
changes agreed under the Basel Convention and the OECD Decision; 

(b)  unclassified  wastes  may  be  added  to  Annex  IIIB,  IV  or  V  on  a 
provisional  basis  pending  a  decision  on  their  inclusion  in  the  relevant 
Annexes to the Basel Convention or to the OECD Decision; 

(c) 

following  the  submission  of  a  request  by  a  Member  State,  mixtures  of 
two or more wastes listed in Annex III may be considered for inclusion in 
Annex IIIA in the cases referred to in Article 3(2) on a provisional basis 
pending a decision on their inclusion in the relevant Annexes to the Basel 
Convention  or  to  the  OECD  Decision.  Annex  IIIA  may  contain  the 
proviso that one or more of the entries therein shall not apply for exports 
to countries to which the OECD Decision does not apply; 

(d) 

the exceptional cases referred to in Article 3(3) shall be determined and, 
where necessary, such waste shall be added to Annexes IVA and V and 
deleted from Annex III; 

25 

OJ L 190, 12.7.2006, p. 1. 

EN 

31 

   EN 

 
                                                 
(e)  Annex  V  shall  be  amended  to  reflect  agreed  changes  to  the  list  of 
hazardous  waste  adopted  in  accordance  with  Article  1(4)  of  Directive 
91/689/EEC; 

(f)  Annex VIII shall be amended to reflect relevant international conventions 

and agreements. 

2.  When  amending  Annex  IX,  the  Committee  established  by  Council  Directive 

91/692/EEC shall be fully associated with the deliberations.” 

(3) 

Article 59 is replaced by the following: 

“Article 59 

Additional measures 

1. 

The  Commission  may  adopt,  in  accordance  with  the  regulatory  procedure 
referred  to  in  Article  59a(2),  the  following  additional  measures  related  to  the 
implementation of this Regulation: 

(a) 

guidelines for the application of Article 12(1)(g); 

(b)  guidelines on the application of Article 15 in relation to the identification 
and  tracking  of  waste  undergoing  substantial  changes  in  the  interim 
recovery or disposal operation; 

(c) 

(d) 

(e) 

(f) 

guidelines  for  the  cooperation  of  competent  authorities  with  regard  to 
illegal shipments as referred to in Article 24; 

and 

practical 
technical 
implementation  of  electronic  data  interchange  for  the  submission  of 
documents and information in accordance with Article 26(4); 

organisational 

requirements 

the 

for 

further  guidance  concerning  the  use  of  languages  referred  to  in 
Article 27; 

further clarification of the procedural requirements of Title II as regards 
their  application  to  exports,  imports  and  transit  of  waste  from,  to,  and 
through the Community; 

(g) 

further guidance concerning undefined legal terms. 

2. 

The Commission may adopt implementing measures concerning the following:  

(a) 

(b) 

a method for calculating the financial guarantee or equivalent insurance 
as set out in Article 6; 

further conditions and requirements in relation to pre-consented recovery 
facilities as referred to in Article 14. 

EN 

32 

   EN 

 
Those measures, designed to amend non-essential elements of this Regulation 
by  supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 59a(3)." 

(4) 

The following Article 59a is inserted: 

"Article 59a 

Committee procedure 

1. 

The Commission shall be assisted by the committee set up in Article 18(1) of 
Directive 2006/12/EC(*). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months. 

3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

_______________________ 

(*) OJ L 114, 27.4.2006, p. 9.” 

(5) 

Article 63 is amended as follows: 

(a) 

in paragraph 2, the third subparagraph is replaced by the following: 

“With  the  exception  of  glass  waste,  paper  waste  and  waste  pneumatic  tyres, 
this  period  may  be  extended  until  no  later  than  31  December  2012  in 
accordance with the regulatory procedure referred to in Article 59a(2)” 

(b) 

in paragraph 4, the third subparagraph is replaced by the following: 

“This  period  may  be  extended  until  no  later  than  31  December  2012  in 
accordance with the procedure referred to in Article 59a(2).” 

(c) 

paragraph 5 is amended as follows:  

(i) 

the third subparagraph is replaced by the following: 

“This  period  may  be  extended  until  no  later  than  31  December  2015  in 
accordance with the regulatory procedure referred to in Article 59a(2).” 

(ii) 

the fifth subparagraph is replaced by the following: 

“This  period  may  be  extended  until  no  later  than  31  December  2015  in 
accordance with the regulatory procedure referred to in Article 59a(2)” 

EN 

33 

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4. 

EUROSTAT 

4.1. 

Council  Regulation  (EEC)  No  3924/91  of  19  December  1991  on  the 
establishment of a Community survey of industrial production26  

As  regards  Regulation  (EEC)  No  3924/91,  power  should  in  particular  be  conferred  on  the 
Commission to establish and update the list of products concerned by that Regulation. Power 
should  also  be  conferred  on  it  to  adopt  detailed  rules  as  regards  representativeness  and 
periodicity  for  certain  products  and  to  establish  the  arrangements  for  survey  contents  and 
implementing  measures,  including  the  measures  for  adjustment  to  technical  progress 
concerning  collection  of  data  and  the  processing  of  the  results.  Since  those  measures  are  of 
general  scope  and  are  designed  to  amend  non-essential  elements  of  Regulation  (EEC) 
No 3924/91, inter alia by supplementing it by the addition of new non-essential elements, they 
must  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  provided  for  in 
Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EEC) No 3924/91 is amended as follows: 

(1) 

In Article 2, paragraph 6 is replaced by the following: 

“6.  The Prodcom list, the information actually collected for each heading and the 
other  implementing  procedures  of  this  Regulation  shall  be  established  and 
updated by the Commission. Those measures, designed to amend non-essential 
elements of this Regulation, inter alia by supplementing it, shall be adopted in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
10(3).” 

(2) 

Article 3 is amended as follows: 

a) 

In  paragraph  2  the  words  “in  Article  10”  are  replaced  by  the  words  “in 
Article 10(2)”. 

b) 

Paragraph 5 is replaced by the following: 

“5.  Detailed  rules  for  applying  this  Article,  including  measures  for 
adjustment  to  technical  progress,  shall  be  adopted,  as  necessary,  by  the 
Commission. Those measures, designed to amend non-essential elements 
of  this  Regulation,  inter  alia  by  supplementing  it,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 10(3).” 

(3) 

Article 4 is replaced by the following: 

26 

OJ L 374, 31.12.1991, p.1. Regulation last amended by Regulation (EC) No 1893/2006 of the European 
Parliament and of the Council (OJ L 393, 30.12.2006, p. 1). 

EN 

34 

   EN 

 
                                                 
“Article 4 

Survey periods 

The survey shall cover an annual period of one calendar year. 

However,  for  certain  headings  in  the  Prodcom  list,  monthly  or  quarterly 
surveys  may  be  decided  by  the  Commission.  Those  measures,  designed  to 
amend non-essential elements of this Regulation, inter alia by supplementing it, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 10(3).” 

(4) 

In Article 5, paragraph 1 is replaced by the following: 

“1.  The required information shall be collected by the Member States using survey 
questionnaires  the  content  of  which  shall  comply  with  the  arrangements 
defined by the Commission. Those measures, designed to amend non-essential 
elements of this Regulation, inter alia by supplementing it, shall be adopted in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 10(3).” 

(5) 

In Article 6 and in Article 7(2) the words “in Article 10” are replaced by the words 
“in Article 10(2)”.  

(6) 

Articles 9 and 10 are replaced by the following: 

“Article 9 

Implementing measures 

The measures for adjustment to technical progress concerning collection of data and 
the processing of the results shall be adopted by the Commission. Those measures, 
designed  to  amend  non-essential  elements  of  this  Regulation,  inter  alia  by 
supplementing  it,  shall  be  laid  down  in  accordance  with  the  regulatory  procedure 
with  scrutiny  referred  to  in  Article  10(3).  Other  measures  for  implementing  this 
Regulation  shall  be  adopted  by  the  Commission  in  accordance  with  the  procedure 
referred to in Article 10(2). 

Article 10 

Committee 

1. 

The  Commission  shall  be  assisted  by  the  Statistical  Programme  Committee 
established by Council Decision 89/382/EEC, Euratom(*). 

2.  Where  reference  is  made  to  this  paragraph,  Article  4  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

EN 

35 

   EN 

 
The  time  limit  laid  down  in  Article  4(3)  of  Decision  1999/468/EC  shall  be 
three months. 

3.  Where reference is made to this paragraph, Articles 5a(1) to (4), and Article 7 
of Decision 1999/468/EC shall apply, having regard to the provisions of Article 
8 thereof. 

____________________________ 

(*) OJ L 181, 28.6.1989, p. 47.” 

4.2. 

Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and 
milk products27  

As regards Directive 96/16/EC, power should in particular be conferred on the Commission to 
adopt the definitions for the agricultural holdings among which Member States must conduct 
surveys of the production of milk and its use, determine the list of milk products covered by 
the surveys and lay down standard definitions to be used for communicating the results to the 
Commission.  Since  those  measures  are  of  general  scope  and  are  designed  to  supplement 
Directive  96/16/EC  by  adding  new  non-essential  elements,  they  must  be  adopted  in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 
1999/468/EC. 

Accordingly, Directive 96/16/EC is amended as follows: 

(1) 

Article 1(2) is replaced by the following: 

"2) 

shall  carry  out  annual  surveys  of  the  production  of  milk  and  its  use  among 
agricultural  holdings  as  defined  by  the  Commission;  the  measures  defining 
agricultural  holdings,  designed  to  amend  non-essential  elements  of  this 
Directive  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 7(3)." 

(2) 

Article 3(2) and (3) are replaced by the following:  

"2.  The  list  of  milk  products  covered  by  the  surveys  shall  be  adopted  by  the 
Commission.  Those  measures,  designed  to  amend  non-essential  elements  of 
this  Directive  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 7(3). 

3. 

The  standard  definitions  to  be  used  for  communicating  the  results  for  the 
various  products  shall  be  drawn  up  by  the  Commission.  Those  measures, 
designed  to  amend  non-essential  elements  of  this  Directive  by  supplementing 
it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 7(3)." 

(3) 

In  Article  4(2)  and  Article  6(1),  the  words  "in  Article  7"  are  replaced  by  "in 
Article 7(2)". 

27 

OJ  L  78,  28.3.1996,  p.  27.  Directive  as  last  amended  by  Directive  2003/107/EC  of  the  European 
Parliament and of the Council (OJ L 7, 13.1.2004, p. 40). 

EN 

36 

   EN 

 
                                                 
(4) 

Article 7 is replaced by the following: 

"Article 7 

1. 

The Commission shall be assisted by the Standing Committee on Agricultural 
Statistics set up by Council Decision 72/279/EEC(*).  

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months. 

3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

____________________ 

(*) OJ L 179, 7.8.1972, p. 1." 

4.3. 

Directive  2001/109/EC  of  the  European  Parliament  and  of  the  Council  of  19 
December  2001  concerning  the  statistical  surveys  to  be  carried  out  by  the 
Member States in order to determine the production potential of plantations of 
certain species of fruit trees28 

As  regards  Directive  2001/109/EC,  power  should  in  particular  be  conferred  on  the 
Commission to amend the list of species of fruit trees and the table of species surveyed in the 
Member  States,  to  adopt  the  detailed  rules  for  the  application  of  certain  articles  and  to 
determine  the  boundaries  of  the  production  areas  to  be  adopted  for  Member  States.  Since 
those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of 
Directive 2001/109/EC and to supplement the Directive by the addition of new non-essential 
elements,  they  must  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 2001/109/EC is amended as follows: 

(1) 

The third subparagraph of Article 1(2) is replaced by the following: 

"The  list  of  said  species  and  the  said  table  may  be  amended  by  the  Commission. 
Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 8(2)." 

28 

OJ L 13, 16.1.2002, p. 21. Directive as last amended by Directive 2006/110/EC (OJ L 363, 20.12.2006, 
p. 418). 

EN 

37 

   EN 

 
 
                                                 
(2) 

Article 2(2) is replaced by the following: 

"2.  Detailed  rules  for  applying  this  Article  shall  be  adopted  by  the  Commission. 
Those measures, designed to amend non-essential elements of this Directive by 
supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 8(2)." 

(3) 

Article 3(4) is replaced by the following: 

"4.  Detailed  rules  for  applying  this  Article  shall  be  adopted  by  the  Commission. 
Those measures, designed to amend non-essential elements of this Directive by 
supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 8(2)." 

(4) 

Article 4(2) is replaced by the following: 

"2.  The  results  referred  to  in  paragraph  1  shall  be  supplied  for  each  production 
area. The boundaries of the production areas to be adopted for Member States 
shall be adopted by the Commission. Those measures, designed to amend non-
essential  elements  of  this  Directive  by  supplementing  it,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 8(2)." 

(5) 

Article 8 is replaced by the following: 

"Article 8 

1. 

The Commission shall be assisted by the Standing Committee on Agricultural 
Statistics set up by Council Decision 72/279/EEC(*).  

2.  Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4)  and  5(a),  and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions 
of Article 8 thereof. 

(*) OJ L 179, 7.8.1972, p.1." 

4.4. 

Regulation (EC) No 91/2003 of the European Parliament and of the Council of 
16 December 2002 on rail transport statistics29 

As  regards  Regulation  (EC)  No  91/2003,  power  should  in  particular  be  conferred  on  the 
Commission to adapt the definitions and adopt additional provisions, to adapt the content of 
the annexes and to define the guidelines for the reports on the quality and comparability of the 
results.  Since  those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential 
elements  of  Regulation  (EC)  No  91/2003  and  to  supplement  it  by  the  addition  of  new  non-
essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny provided for in Article 5a of Decision 1999/468/EC. 

29 

OJ L 14, 21.1.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1192/2003 (OJ L 
167, 4.7.2003, p. 13). 

EN 

38 

   EN 

 
 
                                                 
Accordingly, Regulation (EC) No 91/2003 is amended as follows: 

(1) 

Article 3(2) is replaced by the following: 

"2.  The  definitions  referred  to  in  paragraph  1  may  be  adapted,  and  additional 
definitions needed to ensure harmonisation of statistics may be adopted by the 
Commission.  Those  measures,  designed  to  amend  non-essential  elements  of 
this Regulation, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 11(3)." 

(2) 

Article 4 is amended as follows: 

a) 

Paragraph 2 is replaced by the following: 

"2.  Annexes B and D set out simplified reporting requirements, which may be used 
by  Member  States  as  alternatives  to  the  normal  detailed  reporting  set  out  in 
Annexes  A  and  C,  for  undertakings  for  which  the  total  volume  of  goods  or 
passenger transport is less than 500 million tonne-km or 200 million passenger-
km respectively. These thresholds may be adapted by the Commission. Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  shall 
be adopted in accordance with the regulatory procedure with scrutiny referred 
to in Article 11(3)." 

b) 

Paragraph 5 is replaced by the following: 

"5.  The  contents  of  the  Annexes  may  be  adapted  by  the  Commission.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  shall 
be adopted in accordance with the regulatory procedure with scrutiny referred 
to in Article 11(3)." 

(3) 

Article 10 is replaced by the following: 

"Article 10 

Implementing procedures 

1. 

The  arrangements  for  transmission  of  the  data  to  Eurostat  shall  be  made  in 
accordance with the procedure specified in Article 11(2).  

2. 

The Commission shall adopt the following implementing measures:  

a) 

b) 

c) 

d) 

adaptation of the thresholds for simplified reporting (Article 4); 

adaptation  of  the  definitions  and  adoption  of  additional  definitions 
(Article 3(2)); 

adaptation of the contents of the annexes (Article 4); 

definition  of  the  guidelines  for  the  reports  on  the  quality  and 
comparability of the results (Articles 8 and 9).  

EN 

39 

   EN 

 
Those  measures,  designed  to  amend  or  supplement  non-essential  elements  of 
this Regulation, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 11(3)." 

(4) 

Article 11 is replaced by the following: 

"Article 11 

Committee 

1. 

The  Commission  shall  be  assisted  by  the  Statistical  Programme  Committee 
instituted by Council Decision 89/382/EEC, Euratom(*). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months.  

3.  Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(a), and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions 
of Article 8 thereof. 

_____________________ 

(*) OJ L 181, 28.6.1989, p. 47." 

(5) 

4.5. 

In point 5 of Annex H, and in Annex J, the words "in Article 11(2)" are replaced by 
"in Article 11(3)". 

Regulation (EC) No 437/2003 of the European Parliament and of the Council of 
27 February 2003 on statistical returns in respect of the carriage of passengers, 
freight and mail by air30  

As  regards  Regulation  (EC)  No  437/2003,  power  should  in  particular  be  conferred  on  the 
Commission to amend the definitions in the Regulation, to adopt additional provisions and to 
adapt the content of the annexes thereto. Since those measures are of general scope and are 
designed  to  amend  non-essential  elements  of  Regulation  (EC)  No  437/2003,  they  must  be 
adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a 
of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 437/2003 is amended as follows: 

30 

OJ L 66, 11.3.2003, p. 1. Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 
363, 20.12.2006, p. 1.)  

EN 

40 

   EN 

 
                                                 
(1) 

Article 3(2) is replaced by the following: 

"2.  Each Member State shall collect all data set out in Annex I for all Community 
airports  in  its  territory  with  traffic  in  excess  of  150 000  passenger  units 
annually. 

A list of Community airports covered by the first subparagraph shall be drawn 
up by the Commission and, if necessary, updated. Those measures, designed to 
amend  non-essential  elements  of  this  Regulation,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 11(3)." 

(2) 

Article 5 is replaced by the following: 

"Article 5 

Accuracy of statistics 

The collection of data shall be based on complete returns, unless other standards of 
accuracy  are  established  by  the  Commission.  Those  measures,  designed  to  amend 
non-essential  elements  of  this  Regulation  by  supplementing  it,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 11(3)." 

(3) 

Article 7(2) is replaced by the following: 

"2.  The results shall be transmitted according to the data files shown in Annex I. 
The  files  shall  be  specified  by  the  Commission.  That  measure,  designed  to 
amend  non-essential  elements  of  this  Regulation,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 11(3).  

The medium to be used for transmission shall be specified by the Commission 
in accordance with the procedure laid down in Article 11(2)." 

(4) 

Article 10 is replaced by the following: 

"Article 10 

Implementing arrangements 

1. 

— 

The following implementing measures shall be adopted in accordance with the 
procedure referred to in Article 11(2): 

description  of  the  data  codes  and  the  medium  to  be  used  for  transmission  of 
results to the Commission (Article 7), 

— 

dissemination of statistical results (Article 8). 

EN 

41 

   EN 

 
2. 

The Commission shall adopt the following implementing measures: 

— 

adaptation of the specifications in the Annexes to this Regulation, 

— 

adaptation of the data collection characteristics (Article 3), 

— 

the list of Community airports covered by Article 3(2), 

— 

accuracy of statistics (Article 5), 

— 

description of the data files (Article 7). 

Those  measures,  designed  to  amend  or  supplement  non-essential  elements  of  this 
Regulation,  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 11(3)."  

(5) 

Article 11 is replaced by the following: 

"Article 11 

Committee 

1. 

The  Commission  shall  be  assisted  by  the  Statistical  Programme  Committee 
established by Council Decision 89/382/EEC, Euratom(*). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months. 

3.  Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(a), and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions 
of Article 8 thereof. 

___________________________ 

(*) OJ L 181, 28.6.1989, p. 47." 

4.6. 

Regulation (EC) No 48/2004 of the European Parliament and of the Council of 
5 December 2003 on the production of annual Community statistics on the steel 
industry for the reference years 2003-200931 

As  regards  Regulation  (EC)  No  48/2004,  powers  should  in  particular  be  conferred  on  the 
Commission to establish and update the list of characteristics concerned by that Regulation. 
Since those measures are of general scope and are designed to amend non-essential elements 
of  Regulation  (EC)  No  48/2004,  inter  alia  by  supplementing  it  by  the  addition  of  new  non-

31 

OJ L 7, 13.1.2004, p. 1. 

EN 

42 

   EN 

 
                                                 
essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny provided for in Article 5a of Decision 1999/468/EC.  

Accordingly, Regulation (EC) No 48/2004 is amended as follows: 

(1) 

Article 7 is replaced by the following: 

“Article 7 

Implementing measures 

1. 

2. 

this  Regulation  concerning 
The  measures  for 
transmission  formats  and  the  first  transmission  period  shall  be  adopted  in 
accordance with the procedure referred to in Article 8(2). 

implementation  of 

the 

The  measures  for  the  implementation  of  this  Regulation  concerning  any 
alteration  to  the  list  of  characteristics,  provided  that  no  significant  additional 
burden  is  imposed  upon  the  Member  States,  designed  to  amend  non-essential 
elements of this Regulation, inter alia by supplementing it, shall be adopted in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 8(3).” 

(2) 

In Article 8, paragraph 3 is replaced by the following: 

“3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

5. 

INTERNAL MARKET 

5.1. 

Directive 2004/25/EC of the European Parliament and of the Council of 21 April 
2004 on takeover bids32 

As  regards  Directive  2004/25/EC,  power  should  be  conferred  on  the  Commission  to  adopt 
rules  for  the  application  of  Article  6(3)  on  the  contents  of  the  offer  document.  Since  those 
measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of  this 
Directive,  inter  alia  by  supplementing  it  or  by  the  addition  of  new  non-essential  elements, 
they must be adopted in accordance with the regulatory procedure with scrutiny provided for 
in Article 5a of Decision 1999/468/EC.  

Directive  2004/25/EC  provided  for  a  time  restriction  concerning  the  implementing  powers 
conferred  on  the  Commission.  In  their  joint  statement  on  Decision  2006/512/EC  amending 
Decision  1999/468/EC,  the  European  Parliament,  the  Council  and  the  Commission  have 
stated  that  Decision  2006/512/EC  provides  a  horizontal  and  satisfactory  solution  to  the 
European Parliament's wish to scrutinise the implementation of instruments adopted under the 
co-decision procedure and that, accordingly, implementing powers should be conferred on the 

32 

OJ L 142, 30.4.2004, p. 12. 

EN 

43 

   EN 

 
                                                 
Commission without time limit. Following the introduction of the regulatory procedure with 
scrutiny,  the  provision  establishing  that  time  restriction  in  Directive  2004/25/EC  should  be 
deleted. 

Accordingly, Directive 2004/25/EC is amended as follows: 

(1) 

In Article 6, paragraph 4 is replaced by the following:  

“4.  The  Commission  shall  adopt  rules  for  the  application  of  paragraph  3.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Directive  by 
supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 18(2).”  

(2) 

Article 18 is amended as follows: 

(a) 

paragraph 2 is replaced by the following:  

“2.  Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4),  and 
Article  7  of  Decision  1999/468/EC  shall  apply,  having  regard  to  the 
provisions of Article 8 thereof.” 

(b)  paragraph 3 is deleted. 

6. 

HEALTH AND CONSUMER PROTECTION 

6.1. 

Council  Directive  79/373/EEC  of  2  April  1979  on  the  marketing  of  compound 
feedingstuffs33 

As regards Directive 79/373/EEC, power should in particular be conferred on the Commission 
to adopt exceptions to  the  prescriptions on the packaging of feedingstuffs  and  to amend the 
Annex.  Since  those  measures  are  of  general scope  and  are  designed  to  amend  non-essential 
elements  of  Directive  79/373/EEC  and  to  supplement  the  Directive  by  the  addition  of  new 
non-essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory  procedure 
with scrutiny provided for in Article 5a of Decision 1999/468/EC.  

Accordingly, Directive 79/373/EEC is amended as follows: 

(1) 

Article 4(2) is replaced by the following: 

"2.  The  Commission  shall  adopt  exceptions  to  the  principle  of  paragraph  1  to  be 
authorised  at  Community  level.  Those  measures,  designed  to  amend  non-
essential  elements  of  this  Directive,  inter  alia  by  supplementing  it,  shall  be 
adopted in accordance with the regulatory procedure with scrutiny referred to 
in  Article  13(3),  provided  that  the  identity  and  quality  of  the  compound 
feedingstuffs concerned are ensured." 

(2) 

Article 10 is replaced by the following:  

33 

OJ L 86, 6.4.1979, p. 30. 

EN 

44 

   EN 

 
                                                 
In the light of advances in scientific and technical knowledge: 

"Article 10 

a) 

categories  grouping  several  feed  materials  shall  be  established  not  later  than 
22 January 1991 in accordance with the procedure laid down in Article 13(2); 

b)  methods  of  calculating  the  energy  value  of  compound  feedingstuffs  may  be 
established in accordance with the procedure laid down in Article 13(2); 

c) 

amendments  to  the  Annex  shall  be  adopted  by  the  Commission;  those 
measures, designed to amend non-essential elements of this Directive, shall be 
adopted in accordance with the regulatory procedure with scrutiny referred to 
in Article 13(3)."  

(3) 

Article 13(3) is replaced by the following: 

"3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof." 

6.2. 

Council Directive 82/471/EEC of 30 June 1982 concerning certain products used 
in animal nutrition34 

As regards Directive 82/471/EEC, power should in particular be conferred on the Commission 
to adopt amendments and to lay down the criteria required to define the products included in 
the  Directive.  Since  those  measures  are  of  general  scope  and  are  designed  to  amend  non-
essential elements of Directive 82/471/EEC and to supplement the Directive by the addition 
of  new  non-essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. On grounds of 
urgency, the urgent procedure provided for in Article 5a(6) of Decision 1999/468/EC for the 
adoption of amendments to the Directive must be used. 

Accordingly, Directive 82/471/EEC is amended as follows: 

(1) 

Article 6 is amended as follows: 

(a)  Paragraph 1 is replaced by the following: 

"1.  Amendments to be made to the Annex as a result of developments in scientific 
or technical knowledge shall be adopted by the Commission. Those measures, 
designed to amend non-essential elements of this Directive, shall be adopted in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 13(3). In the case of the products referred to in Sections 1.1 and 1.2 of 
the Annex, the Commission shall consult the Scientific Committee for Animal 
Nutrition and the Scientific Committee for Food. 

34 

OJ L 213, 21.7.1982, p. 8. 

EN 

45 

   EN 

 
                                                 
However, in the case of products obtained from yeasts of the ‘Candida’ variety 
and  cultivated  on  n-alkanes,  referred to in Article  4(1), the Commission shall 
adopt  a  position  within  two  years  of  notification  of  this  Directive,  after 
consulting  the  Scientific  Committee  for  Animal  Nutrition  and  the  Scientific 
Committee for Food." 

(b)  Paragraph 3 is replaced by the following: 

"3.  Criteria  making  it  possible  to  define  the  products  included  in  this 
Directive,  particularly  the  criteria  of  composition  and  purity  and  the 
physico-chemical  and  biological  properties,  may  be  adopted  by  the 
Commission  in  the  light  of  scientific  and  technical  knowledge.  Those 
measures, designed to amend non-essential elements of this Directive by 
supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 13(3)." 

(2) 

In  the  second  subparagraph  of  Article  7(2),  "Article  13"  is  replaced  by  "Article 
13(2)".  

(3) 

Article 8(3) is replaced by the following: 

"3. 

If the Commission considers that amendments to this Directive are necessary to 
alleviate the difficulties referred to in paragraph 1 and to ensure the protection 
of  human  or  animal  health,  it  shall  adopt  such  measures.  Those  measures, 
designed to amend non-essential elements of this Directive, shall be adopted in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 13(4). The Member State that has adopted safeguard measures may in 
that event retain them until the amendments have entered into force." 

(4) 

Article 13 is amended as follows: 

(a)  Paragraph 3 is replaced by the following: 

"3.  Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4)  and 
Article  7  of  Decision  1999/468/EC  shall  apply,  having  regard  to  the 
provisions of Article 8 thereof." 

(b)  The following paragraph 4 is added: 

"4.  Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) 
and Article 7 of Decision 1999/468/EC shall apply, having regard to the 
provisions of Article 8 thereof." 

(5) 

Article 14 is deleted. 

EN 

46 

   EN 

 
6.3. 

Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, 
amending  Directives  70/524/EEC,  74/63/EEC,  82/471/EEC  and  93/74/EEC  and 
repealing Directive 77/101/EEC35 

As regards Directive 96/25/EC, power should in particular be conferred on the Commission to 
lay  down  and  amend  the  list  of  materials  whose  circulation  or  use  for  animal  nutrition 
purposes  is  restricted  or  prohibited  and  to  amend  the  annex  in  the  light  of  advances  in 
scientific  and  technical  knowledge.  Since  those  measures  are  of  general  scope  and  are 
designed  to  amend  non-essential  elements  of  Directive  96/25/EC  and  to  supplement  the 
Directive by the addition of new non-essential elements, they must be adopted in accordance 
with  the  regulatory  procedure  with  scrutiny  provided  for  in  Article  5a  of  Decision 
1999/468/EC.  

When, on imperative grounds of urgency, the normal time limits for the regulatory procedure 
with  scrutiny  cannot  be  complied  with,  the  Commission  must  be  able  to  use  the  urgent 
procedure  provided  for  in  Article  5a(6)  of  Decision  1999/468/EC  for  the  amendment  of  the 
list  of  materials  whose  circulation  or  use  for  animal  nutrition  purposes  is  restricted  or 
prohibited. 

On  grounds  of  efficiency,  the  normal  time  limits  for  the  regulatory  procedure  with  scrutiny 
must  be  curtailed  for  the  adoption  of  amendments  to  the  annex  in  the  light  of  advances  in 
scientific and technical knowledge. 

Accordingly, Directive 96/25/EC is amended as follows: 

(1) 

The second indent of Article 5(1)(g) is replaced by the following:  

"- 

Community  measures  included  on  a  list  to  be  drawn  up  by  the  Commission; 
that  measure,  designed  to  amend  non-essential  elements  of  this  Directive  by 
supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 13(3)." 

(2) 

Article 11 is replaced by the following: 

"Article 11 

1.  A  numerical  coding  system  for  the  listed  feed  materials  based  on  glossaries 
concerning  the  origin,  part  of  the  product/by-product  used,  processing  and 
maturity/quality  of  the  feed  materials  enabling  feed  to  be  identified  at 
international level — in particular by name and description — may be adopted 
in accordance with the procedure referred to in Article 13(2). 

2. 

The list of materials whose circulation or use for animal nutrition purposes is 
restricted or prohibited shall be drawn up by the Commission in order to ensure 
their  compliance  with  Article  3.  That  measure,  designed  to  amend  non-
essential  elements  of  this  Directive  by  supplementing  it,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 13(3). 

35 

OJ L 125, 23.5.1996, p. 35. 

EN 

47 

   EN 

 
                                                 
3. 

The  list  referred  to  paragraph  2  shall  be  amended  by  the  Commission  in  the 
light  of  advances  in  scientific  and  technical  knowledge.  Those  measures, 
designed  to  amend  non-essential  elements  of  this  Directive  by  supplementing 
it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred  to  in  Article  13(3).  On  imperative  grounds  of  urgency,  the 
Commission may use the urgent procedure referred to in Article 13(5) with a 
view to adopting those measures. 

4.  Amendments to be made to the Annex as a result of developments in scientific 
or technical knowledge shall be adopted by the Commission. Those measures, 
designed to amend non-essential elements of this Directive, shall be adopted in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 13(4)." 

(3) 

Article 13 is amended as follows: 

a) 

Paragraph 3 is replaced by the following: 

"3.  Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4)  and 
Article  7  of  Decision  1999/468/EC  shall  apply,  having  regard  to  the 
provisions of Article 8 thereof." 

b) 

The following paragraphs 4 and 5 are added: 

"4.  Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4)  and 
(5)(b), and Article 7 of Decision 1999/468/EC shall apply, having regard 
to the provisions of Article 8 thereof. 

The  time  limits  laid  down  in  Article  5a(3)(c),  (4)(b)  and  (4)(e)  of 
Decision 1999/468/EC shall be two months, one month and two months 
respectively. 

5.  Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) 
and Article 7 of Decision 1999/468/EC shall apply, having regard to the 
provisions of Article 8 thereof." 

6.4. 

Directive 2002/32/EC of the European Parliament and of the Council of 7 May 
2002 on undesirable substances in animal feed36 

As regards Directive 2002/32/EC, power should in particular be conferred on the Commission 
to  amend  Annexes  I  and  II  and  adapt  them  in  the  light  of  developments  in  scientific  and 
technical  knowledge,  and  to  lay  down  additional  criteria  for  detoxification  processes.  Since 
those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of 
Directive  2002/32/EC  and  to  supplement  it  by  the  addition  of  new  non-essential  elements, 
they must be adopted in accordance with the regulatory procedure with scrutiny provided for 
in Article 5a of Decision 1999/468/EC.  

36 

OJ L 140, 30.5.2002, p. 10. 

EN 

48 

   EN 

 
 
                                                 
When,  on  imperative  grounds  of  urgency,  the  time limits  normally  applicable  for  the 
regulatory procedure with scrutiny cannot be complied with, the Commission should be able 
to  use  the  urgent  procedure  provided  for  in  Article  5a(6)  of  Decision  1999/468/EC  for  the 
adaptation  of  Annexes  I  and  II  in  the  light  of  developments  in  scientific  and  technical 
knowledge.  

Accordingly, Directive 2002/32/EC is amended as follows: 

(1) 

The first subparagraph of Article 7(2) is replaced by the following: 

"An  immediate  decision  shall  be  taken  as  to  whether  Annexes  I  and  II  should  be 
amended.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Directive, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 11(4)." 

(2) 

Article 8(1) and (2) are replaced by the following:  

"1.  The Commission shall adapt Annexes I and II in the light of developments in 
scientific  and  technical  knowledge.  Those  measures,  designed  to  amend  non-
essential  elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the 
regulatory procedure  with scrutiny referred to in Article 11(3). On imperative 
grounds of urgency, the Commission may use the urgent procedure referred to 
in Article 11(4) with a view to adopting those amendments. 

2. 

Furthermore the Commission: 

-  shall  periodically  adopt  consolidated  versions  of  Annexes  I  and  II 
incorporating  any  adaptations  made  pursuant  to  paragraph  1,  in  accordance 
with the procedure provided for in Article 11(2), 

- may define acceptability criteria for detoxification processes as a complement 
to  the  criteria  provided  for  products  intended  for  animal  feed  which  have 
undergone  such  processes.  Those  measures,  designed  to  amend  non-essential 
elements of this Directive by supplementing it, shall be adopted in accordance 
with the regulatory procedure with scrutiny referred to in Article 11(3)." 

(3) 

Article 11 is replaced by the following: 

"Article 11 

1. 

The Commission shall be assisted by the Standing Committee for Feedingstuffs 
set up by Article 1 of Decision 70/372/EEC(*). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.  

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months. 

EN 

49 

   EN 

 
3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

4.  Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions 
of Article 8 thereof. 

_________________________________ 

(*) OJ L 170, 3.8.1970, p.1." 

(4) 

Article 12 is deleted. 

6.5. 

Regulation (EC) No 998/2003 of the European Parliament and of the Council of 
26  May  2003  on  the  animal  health  requirements  applicable  to  the  non-
commercial  movements  of  pet  animals  and  amending  Council  Directive 
92/65/EEC37. 

As  regards  Regulation  (EC)  No  998/2003,  power  should  in  particular  be  conferred  on  the 
Commission to amend the list of species of animals set out in Part C of Annex I and the lists 
of countries and territories set out in Parts B and C of Annex II. Since those measures are of 
general scope and are designed to amend non-essential elements of that Regulation, they must 
be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  provided  for  in 
Article 5a of Decision 1999/468/EC. 

On  grounds  of  efficiency,  the  normal  time  limits  for  the  regulatory  procedure  with  scrutiny 
should be curtailed for the adoption of the list of certain third countries. 

Accordingly, Regulation (EC) No 998/2003 is amended as follows: 

(1) 

Article 10 is amended as follows: 

(a)  The introductory phrase is replaced by the following: 

“The list of third countries provided for in part C of Annex II shall be drawn up 
by  the  Commission  [before  the  date  provided  for  in  the  second  paragraph  of 
Article 25]. To be included on that list, a third country must first demonstrate 
its status with regard to rabies and that:” 

(b)  The following second subparagraph is added: 

“Those measures, designed to amend non-essential elements of this Regulation, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 24(5).” 

(2) 

Article 19 is replaced by the following: 

37 

OJ L 146, 13.6.2003, p. 1. 

EN 

50 

   EN 

 
                                                 
“Article 19 

Part  C  of  Annex  I  and  parts  B  and  C  of  Annex  II  may  be  amended  by  the 
Commission  to  take  account  of  developments  in  the  situation  within  Community 
territory  or  in  third  countries  as  regards  diseases  affecting  the  species  of  animals 
covered  by  this  Regulation,  in  particular  rabies,  and,  if  need  be,  limit,  for  the 
purposes  of  this  Regulation,  the  number  of  animals  which  can  be  moved.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  shall  be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 24(4)”. 

(3) 

Article 21 is replaced by the following: 

“Article 21 

Any  transitional  implementing  provisions  may  be  adopted  by  the  Commission  to 
permit the changeover from the current arrangements to the arrangements established 
by  this  Regulation.  Those  measures,  designed  to  amend  non-essential  elements  of 
this  Regulation,  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 24(4)” 

(4) 

Article 24 is amended as follows: 

a) 

Paragraph 4 is replaced by the following: 

“4.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

b) 

The following paragraph 5 is added: 

“5.  Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions 
of Article 8 thereof.  

time 

limits 

The 
in  Article  5a(3)(c),  (4)(b)  and  (4(e)  of 
Decision 1999/468/EC  shall  be  two  months,  one  month  and  two  months 
respectively.” 

laid  down 

6.6. 

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/EEC38 

As regards Directive 2003/99/EC, power should in particular be conferred on the Commission 
to  establish  coordinated  monitoring  programmes  concerning  zoonoses  and  zoonotic  agents. 
Since those measures are of general scope and are designed to amend non-essential elements 
of  that  Directive  and  to  supplement  it  by  the  addition  of  new  non-essential  elements,  they 

38 

OJ L 325, 12.12.2003, p. 31. 

EN 

51 

   EN 

 
                                                 
must  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  provided  for  in 
Article 5a of Decision 1999/468/EC. 

On  the  grounds  of  urgency,  it  is  necessary  to  apply  the  urgent  procedure  provided  for  in 
Article 5a(6)  of  Decision  1999/468/EC  for  the  adoption  of  amendments  to  Annex  I  to 
Directive 2003/99/EC in order to add zoonoses and zoonotic agents to, or delete them from, 
the lists provided for therein. 

Accordingly, Directive 2003/99/EC is amended as follows: 

(1) 

In Article 4, paragraph 4 is amended as follows: 

(a)  The introductory phrase is replaced by the following: 

“Annex I may be amended by the Commission to add zoonoses or zoonotic agents to, 
or  delete  them  from,  the  lists  therein,  taking  account  in  particular  of  the  following 
criteria:” 

(b)  The following second subparagraph is added: 

“Those measures, designed to amend non-essential elements of this Directive, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 12(4).” 

(2) 

In Article 5, paragraph 1 is replaced by the following: 

“1. 

If  data  collected  through  routine  monitoring  in  accordance  with  Article  4  are 
not  sufficient,  coordinated  monitoring  programmes  concerning  one  or  more 
zoonoses  and/or  zoonotic  agents  may  be  established  by  the  Commission, 
especially  when  specific  needs  are  identified,  to  assess  risks  or  to  establish 
baseline values related to zoonoses or zoonotic agents at the level of Member 
States  or  at  Community  level.  Those  measures,  designed  to  amend  non-
essential  elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 12(3).” 

(3) 

Article 11 is replaced by the following: 

“Article 11 

Amendments to the Annexes and transitional or implementing measures 

Annexes  II,  III  and  IV  may  be  amended  by  the  Commission.  Those  measures, 
designed  to  amend  non-essential  elements  of  this  Directive,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 12(3). 

Any  appropriate  transitional  or  implementing  measures  may  be  adopted  in 
accordance with the procedure referred to in Article 12(2).” 

EN 

52 

   EN 

 
(4) 

Article 12 is amended as follows: 

a) 

Paragraph 3 is replaced by the following: 

“3.  Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.” 

b) 

The following paragraph 4 is added: 

“4.  Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions 
of Article 8 thereof.” 

6.7. 

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 
29 April 2004 on the hygiene of foodstuffs39 

As  regards  Regulation  (EC)  No  852/2004,  power  should  in  particular  be  conferred  on  the 
Commission  to  adopt  provisions  relating  to  specific  hygiene  rules  and  to  the  approval  of 
establishments, and to grant derogations from Annexes I and II subject to certain conditions. 
Since those measures are of general scope and are designed to amend non-essential elements 
of  this  Regulation  and  to  supplement  it  by  the  addition  of  new  non-essential  elements,  they 
must  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  provided  for  in 
Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 852/2004 is amended as follows: 

(1) 

Article 4(4) is replaced by the following: 

"4.  The criteria, requirements and targets referred to in paragraph 3, and associated 
sampling and analysis methods shall be laid down by the Commission. Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation  by 
supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 14(3)." 

(2) 

Point (c) of Article 6(3) is replaced by the following: 

"(c)  by  a  decision  adopted  by  the  Commission;  that  measure,  designed  to  amend 
non-essential elements of this Regulation, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 14(3)." 

(3) 

Article 13 is amended as follows: 

a) 

Paragraph 1 is amended as follows: 

i) 

the introductory clause is replaced by the following: 

"Annexes I and II may be adapted or updated by the Commission taking into 
account:" 

39 

OJ L 139, 30.4.2004, p. 1. 

EN 

53 

   EN 

 
                                                 
ii) 

the following second subparagraph is added: 

"Those measures, designed to amend non-essential elements of this Regulation, 
inter  alia  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 14(3)." 

b) 

Paragraph 2 is replaced by the following: 

"2  Derogations from Annexes I and II may be granted by the Commission, 
in  particular  in  order  to  facilitate  the  implementation  of  Article  5  for 
small  businesses,  taking  into  account  the  relevant  risk  factors,  provided 
that such derogations do not affect the achievement of the objectives of 
this  Regulation.  Those  measures,  designed  to  amend  non-essential 
elements  of  this  Regulation  by  supplementing  it,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 14(3)."  

(4) 

Article 14(3) is replaced by the following: 

"3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof." 

6.8. 

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 
29 April 2004 laying down specific hygiene rules for food of animal origin40 

As  regards  Regulation  (EC)  No  853/2004,  power  should  in  particular  be  conferred  on  the 
Commission to adopt provisions relating to the general obligations of food business operators 
and  to  the  special  guarantees  for  placing  food  on  the  market  in  Sweden  or  Finland,  and  to 
allow derogations from the annexes subject to certain conditions. Since those measures are of 
general  scope  and  are  designed  to  amend  non-essential  elements  of  this  Regulation  and  to 
supplement  it  by  the  addition  of  new  non-essential  elements,  they  must  be  adopted  in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 
1999/468/EC. 

Accordingly, Regulation (EC) No 853/2004 is amended as follows: 

(1) 

In Article 3(2), the first sentence is replaced by the following: 

"Food business operators shall not use any substance other than potable water — or, 
when  Regulation  (EC)  No  852/2004  or  this  Regulation  permits  its  use,  clean  water 
— to remove surface contamination from products of animal origin, unless use of the 
substance  has  been  approved  by  the  Commission.  Those  measures,  designed  to 
amend  non-essential  elements  of  this  Regulation  by  supplementing  it,  shall  be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 12(3)." 

40 

OJ L 139, 30.4.2004, corrected version in OJ L 226, 25.6.2004, p. 22.  

EN 

54 

   EN 

 
                                                 
(2) 

Article 8(3) is replaced by the following: 

"3.  

a) 

b) 

The requirements of paragraphs 1 and 2 may be updated by the Commission to 
take account in particular of changes to Member States' control programmes or 
the adoption of microbiological criteria in accordance with Regulation (EC) No 
852/2004.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Regulation, inter alia by supplementing it, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 12(3). 

In  accordance  with  the  procedure  referred  to  in  Article  12(2),  the  rules  laid 
down in paragraph 2 of this Article in respect of any of the foodstuffs referred 
to in paragraph 1 of this Article may be extended, in whole or in part, to any 
Member State, or any region of a Member State, that has a control programme 
recognised as equivalent to that approved for Sweden and Finland in respect of 
the food of animal origin concerned." 

(3) 

Article 10 is amended as follows: 

(a)  Paragraph 1 is amended as follows: 

i) 

the introductory clause is replaced by the following: 

"Annexes II and III may be adapted or updated by the Commission taking into 
account:" 

ii) 

the following second subparagraph is added: 

"Those measures, designed to amend non-essential elements of this Regulation, 
inter  alia  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 12(3)." 

(b)  Paragraph 2 is replaced by the following: 

"2.  Exemptions  from  Annex  II  and  III  may  be  granted  by  the  Commission, 
provided  that  they  do  not  affect  the  achievement  of  the  objectives  of  this 
Regulation. Those measures, designed to amend non-essential elements of this 
Regulation, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 12(3)." 

(4) 

The introductory clause of Article 11 is replaced by the following: 

"Without  prejudice  to  the  generality  of  Article  9  and  Article  10(1),  implementing 
measures  may  be  laid  down  in  accordance  with  the  procedure  referred  to  in 
Article 12(2), or amendments to  Annex II or III, measures designed to amend non-
essential  elements  of  this  Regulation,  may  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 12(3):" 

EN 

55 

   EN 

 
(5) 

Article 12(3) is replaced by the following: 

"3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof." 

6.9. 

Regulation (EC) No 854/2004 of the European Parliament and of the Council of 
29 April 2004 laying down specific rules for the organisation of official controls 
on products of animal origin intended for human consumption41 

As regards Regulation (EC) No 854/2004, powers should be conferred on the Commission to 
amend  or  adapt  the  annexes  thereto.  Since  those  measures  are  of  general  scope  and  are 
designed  to  amend  non-essential  elements  of  that  Regulation,  they  must  be  adopted  in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 
1999/468/EC. 

Accordingly, Regulation (EC) No 854/2004 is amended as follows: 

(1) 

Article 17(1) and (2) are replaced by the following: 

"1.  Annexes  I,  II,  III,  IV,  V  and  VI  may  be  amended  or  supplemented  by  the 
Commission  to  take  account  of  scientific  and  technical  progress.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Regulation,  inter 
alia  by  supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 19(3). 

2. 

Exemptions  from  Annexes  I,  II,  III,  IV,  V  and  VI  may  be  granted  by  the 
Commission, provided that they do not affect the achievement of the objectives 
of this Regulation. Those measures, designed to amend non-essential elements 
of this Regulation by supplementing it, shall be adopted in accordance with the 
regulatory procedure with scrutiny referred to in Article 19(3)." 

(2) 

The introductory clause of Article 18 is replaced by the following:  

"Without  prejudice  to  the  generality  of  Article  16  and  Article  17(1),  implementing 
measures  may  be  laid  down  in  accordance  with  the  procedure  referred  to  in 
Article 19(2), or amendments to Annexes I, II, III, IV, V or VI, measures designed to 
amend non-essential elements of this Regulation, may be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 19(3), to specify:"  

(3) 

Article 19(3) is replaced by the following: 

"3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof." 

41 

OJ L 139, 30.4.2004, corrected version in OJ L 226, 25.6.2004, p. 83. 

EN 

56 

   EN 

 
                                                 
6.10.  Regulation (EC) No 183/2005 of the European Parliament and of the Council of 

12 January 2005 laying down requirements for feed hygiene42 

As  regards  Regulation  (EC)  No  183/2005,  power  should  in  particular  be  conferred  on  the 
Commission  to  define  the  microbiological  criteria  and  targets  to  be  met  by  feed  business 
operators, to adopt measures for the approval of establishments, to amend Annexes I, II and 
III, and to grant derogations from those annexes. Since those measures are of general scope 
and  are  designed  to  amend  non-essential  elements  of  Regulation  (EC)  No  183/2005  and  to 
supplement  it  by  the  addition  of  new  non-essential  elements,  they  must  be  adopted  in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 
1999/468/EC. 

Accordingly, Regulation (EC) No 183/2005 is amended as follows: 

(1) 

The second subparagraph of Article 5(3) is replaced by the following: 

"The  criteria  and  targets  referred  to  in  points  (a)  and  (b)  shall  be  adopted  by  the 
Commission.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Regulation by supplementing it, shall be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 31(3)." 

(2) 

Article 10(3) is replaced by the following: 

"3)  approval is required by a Regulation adopted by the Commission; this measure, 
designed to amend non-essential elements of this Regulation by supplementing 
it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 31(3)." 

(3) 

Article 27 is replaced by the following: 

"Article 27 

Amendments to Annexes I, II and III 

Annexes I, II and III may be amended to take account of: 

a) 

b) 

the development of codes of good practice; 

the  experience  gained  from  the  implementation  of  HACCP-based  systems 
pursuant to Article 6; 

(c) 

technological developments; 

(d) 

scientific advice, particularly new risk assessments; 

(e) 

the setting of feed safety targets; 

and 

42 

OJ L 35, 8.2.2005, p. 1. 

EN 

57 

   EN 

 
                                                 
(f) 

the development of requirements relating to specific operations. 

Those measures, designed to amend non-essential elements of this Regulation, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 31(3)." 

(4) 

Article 28 is replaced by the following: 

"Article 28 

Derogations from Annexes I, II and III 

Derogations  from  Annexes  I,  II  and  III  may  be  granted  by  the  Commission  for 
particular  reasons,  provided  that  such  derogations  do  not  affect  the  achievement  of 
the objectives of this Regulation. Those measures, designed to amend non-essential 
elements of this Regulation by supplementing it, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 31(3)."  

(5) 

Article 31(3) is replaced by the following: 

"3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof." 

7. 

ENERGY AND TRANSPORT 

7.1. 

Council  Regulation  (EEC)  No  3821/85  of  20  December  1985  on  recording 
equipment in road transport43 

As  regards  Regulation  (EEC)  No  3821/85,  power  should  in  particular  be  conferred  on  the 
Commission to make the necessary amendments to adapt the Annexes to technical progress. 
Since those measures are of general scope and are designed to amend non-essential elements 
of  Regulation  (EEC)  No  3821/85,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EEC) No 3821/85 is amended as follows:  

(1) 

Article 5(2) is replaced by the following: 

"The  system's  security  must  comply  with  the  technical  requirements  laid  down  in 
Annex IB. The Commission shall ensure that the said Annex stipulates that recording 
equipment may not be granted EC component type-approval until the whole system 
(the  recording  equipment  itself,  driver  card  and  electrical  gearbox  connections)  has 
demonstrated its capacity to resist attempts to tamper with or alter the data on driving 
times. Those measures, designed to amend non-essential elements of this Regulation, 
shall be adopted in accordance with the regulatory procedure with scrutiny referred 

43 

OJ L 370, 31.12.1985, p. 8. 

EN 

58 

   EN 

 
                                                 
to in Article 18(2). The tests necessary to establish this shall be carried out by experts 
familiar with up-to-date tampering techniques." 

(2) 

Article 17(1) is replaced by the following:  

"1.  The  amendments  required  to  adjust  the  annexes  to  technical  progress,  which 
are  measures  designed  to  amend  non-essential  elements  of  this  Regulation, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 18(2)." 

(3) 

Article 18 is replaced by the following:  

1. 

The Commission shall be assisted by a Committee. 

"Article 18  

2.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof." 

7.2. 

Council Directive 97/70/EC of 11 December 1997 setting up a harmonised safety 
regime for fishing vessels of 24 metres in length and over44 

As regards Directive 97/70/EC, power should in particular be conferred on the Commission to 
adopt  provisions  for  the  harmonised  interpretation  of  provisions  of  the  Annex  to  the 
Torremolinos Protocol and for the implementation of the Directive. The Commission should 
also be empowered to amend certain provisions of the Directive and of the annexes thereto in 
order to apply, for the purpose of the Directive, subsequent amendments to the Torremolinos 
Protocol which entered into force after the adoption of the Directive. Since those measures are 
of  general  scope  and  are  designed  to  amend  non-essential  elements  of  Directive  97/70/EC, 
they must be adopted in accordance with the regulatory procedure with scrutiny provided for 
in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 97/70/EC is amended as follows: 

(1) 

(2) 

In Article 4(4)(b), the words "in Article 9" are replaced by "in Article 9(2)".  

In Article 8, the first subparagraph is replaced by the following: 

"The  following  adaptations,  which  are  measures  designed  to  amend  non-essential 
elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 9(3): 

44 

OJ L 34, 9.2.1998, p. 1. 

EN 

59 

   EN 

 
                                                 
a) 

provisions may be adopted and incorporated for: 

– 

interpretation  of  provisions  of 

a  harmonised 
the 
Torremolinos  Protocol  which  have  been  left  to  the  discretion  of  the 
administrations  of  individual  contracting  parties,  as  far  as  necessary  to 
ensure their consistent implementation in the Community, 

the  Annex 

to 

– 

the implementation of this Directive without broadening its scope. 

b)  Articles 2, 3, 4, 6 and 7 of this Directive may be adapted and its Annexes may 
be  amended  in  order  to  apply,  for  the  purpose  of  this  Directive,  subsequent 
amendments to the Torremolinos Protocol which have entered into force after 
the adoption of this Directive." 

(3) 

Article 9 is replaced by the following: 

"Article 9  

Committee 

1. 

The  Commission  shall  be  assisted  by  the  Committee  on  Safe  Seas  and  the 
Prevention of Pollution from Ships  (COSS)  set  up  by  Article 3  of  Regulation 
(EC) No 2099/2002(*). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The time limit laid down in Article 5(6) of Decision 1999/468/EC shall be two 
months. 

3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

_______________ 

(*) OJ L 324, 29.11.2002, p.1." 

7.3. 

Council  Directive  1999/35/EC  of  29  April  1999  on  a  system  of  mandatory 
surveys for the safe operation of regular ro-ro ferry and high-speed  passenger 
craft services45 

As regards Directive 1999/35/EC, power should in particular be conferred on the Commission 
to adapt the Annexes, definitions and references to Community instruments and instruments 
of  the  International  Maritime  Organisation  (IMO)  in  order  to  bring  them  into  line  with 
Community or IMO measures which have subsequently entered into force. The Commission 
should also be empowered to amend the annexes in order to improve the regime established 
by the Directive. Since those measures are of general scope and are designed to amend non-

45 

OJ L 138, 1.6.1999, p. 1. 

EN 

60 

   EN 

 
                                                 
essential  elements  of  Directive  1999/35/EC,  they  must  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 1999/35/EC is amended as follows: 

(1) 

In Article 4(1)(d), last sentence, Article 11(6) and (8), and Article 13(3), second and 
last sentences, the words "in Article 16" are replaced by "in Article 16(2)". 

(2) 

Article 16 is replaced by the following: 

"Article 16 

Committee 

1. 

The  Commission  shall  be  assisted  by  the  Committee  on  Safe  Seas  and  the 
Prevention of Pollution from Ships  (COSS)  set  up  by  Article 3  of  Regulation 
(EC) No 2099/2002 of the European Parliament and of the Council(*). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Council 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof.  

The time limit laid down in Article 5(6) of Decision 1999/468/EC shall be two 
months.  

3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

___________________________ 

(*) OJ L 324, 29.11.2002, p.1." 

(3) 

Article 17 is replaced by the following: 

"Article 17 

Amendment procedure 

The  Annexes  to  this  Directive,  the  definitions,  the  references  to  Community 
instruments  and  references  to  IMO  instruments  may  be  amended  to  the  extent 
necessary  to  bring  them  into  line  with  Community  or  IMO  measures  which  have 
entered into force, but without broadening the scope of this Directive. 

The Annexes may also be amended when it is necessary to improve the arrangements 
established by this Directive, but without broadening its scope. 

EN 

61 

   EN 

 
Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 16(3). 

The  amendments  to  the  international  instruments  referred  to  in  Article  2  may  be 
excluded from the scope of this  Directive pursuant to  Article 5 of Regulation (EC) 
No 2099/2002."  

7.4. 

Regulation (EC) No 417/2002 of the European Parliament and of the Council of 
18  February  2002  on  the  accelerated  phasing-in  of  double  hull  or  equivalent 
design requirements for single hull oil tankers and repealing Council Regulation 
(EC) No 2978/9446 

As  regards  Regulation  (EC)  No  417/2002,  power  should  in  particular  be  conferred  on  the 
Commission to amend certain references to the relevant regulations in MARPOL 73/78 and to 
Resolutions  MEPC  111(50)  and  94(46)  in  order  to  bring  the  references  into  line  with 
amendments  to  these  regulations  and  resolutions  adopted  by  the  IMO,  in  so  far  as  such 
amendments do not broaden the scope of this Regulation. Since those measures are of general 
scope  and  are  designed  to  amend  non-essential  elements  of  Regulation  (EC)  No  417/2002, 
they must be adopted in accordance with the regulatory procedure with scrutiny provided for 
in Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 417/2002 is amended as follows: 

(1) 

Article 10 is replaced by the following: 

"Article 10 

Committee procedure 

1. 

The  Commission  shall  be  assisted  by  the  Committee  on  Safe  Seas  and  the 
Prevention of Pollution from  Ships (COSS)  set  up  by  Article 3  of  Regulation 
(EC) No 2099/2002 of the European Parliament and of the Council(*). 

2.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

_______________ 

(*) OJ L 324, 29.11.2002, p.1." 

46 

OJ L 64, 7.3.2002, p. 1. 

EN 

62 

   EN 

 
                                                 
(2) 

In Article 11, the first subparagraph is replaced by the following: 

"The Commission may amend the references in the Articles of this Regulation to the 
regulations  of  Annex  I  of  MARPOL  73/78  and  to  Resolutions  MEPC  111(50)  and 
94(46), as amended by MEPC Resolutions 99(48) and 112(50), in order to bring the 
references into line with amendments to these regulations and resolutions adopted by 
the IMO, in so far as such amendments do not broaden the scope of this Regulation. 
Those measures, designed to amend non-essential elements of this Regulation, shall 
be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 10(2)." 

7.5. 

Regulation (EC) No 782/2003 of the European Parliament and of the Council of 
14 April 2003 on the prohibition of organotin compounds on ships47 

As  regards  Regulation  (EC)  No  782/2003,  power  should  in  particular  be  conferred  on  the 
Commission  to  introduce  a  harmonised  survey  and  certification  regime  for  certain  ships,  to 
take certain measures as regards ships sailing under the flag of a third State, to lay down port 
State  control  procedures,  and  to  amend  certain  references  and  annexes  to  take  account  of 
developments  at  international  level,  in  particular  in  the  International  Maritime  Organisation 
(IMO),  or  to  improve  the  effectiveness  of  the  Regulation  in  the  light  of  experience.  Since 
those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of 
Regulation  (EC)  No  782/2003,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Regulation (EC) No 782/2003 is amended as follows: 

(1) 

Article 6 is amended as follows: 

a) 

In paragraph 1(b), the second subparagraph is replaced by the following:  

"If  necessary,  the  Commission  may  establish  a  harmonised  survey  and 
certification  regime  for  these  ships.  That  measure,  designed  to  amend  non-
essential elements of this Regulation, shall be adopted in accordance with the 
regulatory procedure with scrutiny referred to in Article 9(2)." 

b) 

Paragraph 3 is replaced by the following: 

"3. 

If  the  AFS-Convention  has  not  entered  into  force  by  [1  January  2007], 
the Commission shall adopt appropriate measures in order to allow ships 
flying  the  flag  of  a  third  State  to  demonstrate  their  compliance  with 
Article 5. Those measures, designed to amend non-essential elements of 
this  Regulation,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 9(2)." 

47 

OJ L 115, 9.5.2003, p. 1. 

EN 

63 

   EN 

 
                                                 
(2) 

In Article 7, the second subparagraph is replaced by the following: 

"If  the  AFS-Convention  has  not  entered  into  force  by  [1  January  2007],  the 
Commission shall establish appropriate procedures for these controls. That measure, 
designed  to  amend  non-essential  elements  of  this  Regulation,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 9(2)." 

(3) 

Article 8 is replaced by the following: 

"Article 8 

In order to take account of developments at international level and in particular in the 
International  Maritime  Organisation  (IMO),  or  to  improve  the  effectiveness  of  this 
Regulation in the light of experience, the Commission may amend the references to 
the AFS-Convention, to the AFS-Certificate, to the AFS-Declaration and to the AFS-
Statement of Compliance and/or the Annexes to this Regulation, including relevant 
IMO  guidelines  in  relation  to  Article  11  of  the  AFS-Convention.  Those  measures, 
designed  to  amend  non-essential  elements  of  this  Regulation,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 9(2)." 

(4) 

Article 9 is replaced by the following: 

"Article 9 

1. 

The  Commission  shall  be  assisted  by  the  Committee  on  Safe  Seas  and  the 
Prevention of Pollution from Ships  (COSS)  set  up  by  Article 3  of  Regulation 
(EC) No 2099/2002 of the European Parliament and of the Council(*). 

2.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

___________________________ 

(*) OJ L 324, 29.11.2002, p.1."  

7.6. 

Directive  2004/8/EC  of  the  European  Parliament  and  of  the  Council  of  11 
February 2004 on the promotion of cogeneration based on a useful heat demand 
in the internal energy market48 and amending Directive 92/42/EEC  

As regards Directive 2004/8/EC, power should in particular be conferred on the Commission 
to  review  harmonised  efficiency  reference  values  for  separate  production  of  electricity  and 
heat, to adapt the threshold values set out in Article 13 to technical progress, and to establish 
and adapt to technical progress the detailed guidelines for the implementation and application 
of Annex  II of  Directive 2004/8/EC, including  the determination  of the power to heat ratio. 
Since those measures are of general scope and are designed to amend non-essential elements 
of Directive 2004/8/EC and to supplement it by the addition of new non-essential elements, 

48 

OJ L 52, 21.2.2004, p. 50. 

EN 

64 

   EN 

 
                                                 
they must be adopted in accordance with the regulatory procedure with scrutiny provided for 
in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 2004/8/EC is amended as follows: 

(1) 

In Article 4, paragraph 2 is replaced by the following: 

"2.  The  Commission  shall  review  the  harmonised  efficiency  reference  values  for 
separate  production  of  electricity  and  heat  referred  to  in  paragraph  1,  for  the 
first time on 21 February 2011, and every four years thereafter, to take account 
of  technological  developments  and  changes  in  the  distribution  of  energy 
sources. Any measures resulting from this review, designed to amend the non-
essential  elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 14(2)." 

(2) 

Article 13 is replaced by the following:  

"Article 13 

Review 

1. 

2. 

3. 

The  Commission  shall  adapt  the  threshold  values  used  for  calculation  of 
electricity  from  cogeneration  referred  to  in  Annex  II(a)  to  technical  progress. 
Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive, 
shall  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 14(2). 

The  Commission  shall  adapt  the  threshold  values  used  for  calculation  of 
efficiency of cogeneration production and primary energy savings referred to in 
Annex  III(a)  to  technical  progress.  Those  measures,  designed  to  amend  non-
essential  elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 14(2). 

The Commission shall adapt the guidelines for determining the power to heat 
ratio referred to in Annex II(d) to technical progress. Those measures, designed 
to  amend  non-essential  elements  of  this  Directive,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 14(2)." 

(3) 

Article 14 is replaced by the following: 

EN 

65 

   EN 

 
"Article 14 

Committee 

1. 

The Commission shall be assisted by a committee. 

2.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof." 

(4) 

In Annex II, point (e) is replaced by the following: 

"(e)  The Commission shall establish detailed guidelines for the implementation and 
application of Annex II, including the determination of the power to heat ratio. 
Those measures, designed to amend non-essential elements of this Directive by 
supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 14(2)." 

7.7. 

Directive 2004/52/EC of the European Parliament and of the Council of 29 April 
2004 on the interoperability of electronic road toll systems in the Community49 

As regards Directive 2004/52/EC, power should in particular be conferred on the Commission 
to adapt the annex, to take decisions as regard the definition of the European electronic toll 
service  by  [1  July  2006]  and,  if  they  are  not  taken  by  that  date,  to  set  a  new  date.  The 
Commission should also be empowered to take technical decisions relating to the realisation 
of  the  European  electronic  toll  service.  Since  those  measures  are  of  general  scope  and  are 
designed to amend non-essential elements of Directive 2004/52/EC or to supplement it by the 
addition  of  new  non-essential  elements,  they  must  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 2004/52/EC is amended as follows: 

(1) 

Article 4(2), (4), (5) and (6) are replaced by the following: 

"2.  Where  appropriate,  this  Annex  may  be  modified  for  technical  reasons.  Those 
measures, designed to amend non-essential elements of this Directive, shall be 
adopted in accordance with the regulatory procedure with scrutiny referred to 
in Article 5(2). 

4. 

The decisions relating to the definition of the European electronic toll service 
shall be taken by the Commission by [1 July 2006]. Those measures, designed 
to amend non-essential elements of this Directive by supplementing it, shall be 
adopted in accordance with the regulatory procedure with scrutiny referred to 
in  Article  5(2).  Such  decisions  shall  only  be  taken  if  all  the  conditions, 
evaluated  on  the  basis  of  appropriate  studies,  are  in  place  to  enable 
interoperability to work from all points of view, including technical, legal and 
commercial. 

49 

OJ L 166, 30.4.2004, p. 124. 

EN 

66 

   EN 

 
                                                 
5. 

6. 

If the decisions referred to in paragraph 4 are not taken by [1 July 2006], the 
Commission shall set a new date by which such decisions are to be taken. That 
measure, designed to amend a non-essential element of this Directive, shall be 
adopted in accordance with the regulatory procedure with scrutiny referred to 
in Article 5(2). 

Technical  decisions  relating  to  the  realisation  of  the  European  electronic  toll 
service shall be taken by the Commission. Those measures, designed to amend 
non-essential elements of this Directive by supplementing it, shall be adopted 
in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 5(2)." 

(2) 

Article 5 is replaced by the following: 

"Article 5  

Committee 

1. 

The Commission shall be assisted by an Electronic Toll Committee (hereinafter 
"the Committee").  

2.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof."  

7.8. 

Regulation (EC) No 725/2004 of the European Parliament and of the Council of 
31 March 2004 on enhancing ship and port facility security50 

As  regards  Regulation  (EC)  No  725/2004,  power  should  in  particular  be  conferred  on  the 
Commission  to  decide  whether  amendments  to  the  Annexes,  which  concern  certain  special 
measures to enhance maritime security of the International Convention for the Safety of Life 
at Sea, and of the International Code for the security of ships and of port facilities, that apply 
automatically  to  international  traffic  should  also  apply  to  ships  operating  domestic  services 
and  the  port  facilities  serving  them.  Since  those  measures  are  of  general  scope  and  are 
designed  to  amend  non-essential  elements  of  Regulation  (EC)  No  725/2004,  they  must  be 
adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a 
of Decision 1999/468/EC. 

Regulation (EC) No 725/2004 lays down security requirements and measures and is based on 
international instruments that are subject to amendment. On grounds of efficiency, the normal 
time limits for the regulatory procedure with scrutiny should be curtailed for the adaptation of 
its Annexes. 

Accordingly, Regulation (EC) No 725/2004 is amended as follows: 

50 

OJ L 129, 29.4.2004, p. 6. 

EN 

67 

   EN 

 
                                                 
(1) 

In Article 10, paragraph 2 is replaced by the following: 

“2.  The  Commission  shall  decide  integration  of  amendments  to  the  international 
instruments  referred  to  in  Article  2  in  respect  of  ships  operating  domestic 
services and the port facilities serving them to which this Regulation applies, in 
so  far  as  they  constitute  a  technical  update  of  the  provisions  of  the  SOLAS 
Convention  and  the  ISPS  Code.  Those  measures,  designed  to  amend  non-
essential elements of this Regulation, shall be adopted in accordance with the 
regulatory procedure with scrutiny referred to in Article 11(4). The procedure 
for  checking  conformity  established  in  paragraph  5  shall  not  apply  in  these 
cases.” 

(2) 

Article 11 is replaced by the following: 

1. 

The Commission shall be assisted by a Committee. 

“Article 11 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The time limit laid down in Article 5(6) of Decision 1999/468/EC shall be one 
month. 

3.  Where  reference  is  made  to  this  paragraph,  Articles  6  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The  periods  laid  down  in  Article  6(b)  and  (c)  respectively  of  Decision 
1999/468/EC shall be one month. 

4.  Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and 
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions 
of Article 8 thereof. 

The  time  limits  laid  down  in  Article  5a(3)(c),  (4)(b)  and  (4)(e)  of 
Decision 1999/468/EC shall be one month.” 

7.9. 

Regulation (EC) No 789/2004 of the European Parliament and of the Council of 
21  April  2004  on  the  transfer  of  cargo  and  passenger  ships  between  registers 
within the Community and repealing Council Regulation (EEC) No 613/9151 

As  regards  Regulation  (EC)  No  789/2004,  power  should  in  particular  be  conferred  on  the 
Commission  to  amend  certain  definitions  in  order  to  take  account  of  developments  at 
international  level,  in  particular  in  the  International  Maritime  Organisation  (IMO),  and  to 
improve the effectiveness of the Regulation in the light of experience and technical progress. 
Since those measures are of general scope and are designed to amend non-essential elements 
of  Regulation  (EC)  No  789/2004,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

51 

OJ L 138, 30.04.2004, p. 19. 

EN 

68 

   EN 

 
                                                 
Accordingly, Regulation (EC) No 789/2004 is amended as follows: 

(1) 

Article 7 is replaced by the following: 

"Article 7 

1. 

The  Commission  shall  be  assisted  by  the  Committee  on  Safe  Seas  and  the 
Prevention of Pollution from Ships  (COSS)  set  up  by  Article 3  of  Regulation 
(EC) No 2099/2002 of the European Parliament and of the Council(*). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The time limit laid down in Article 5(6) of Decision 1999/468/EC shall be two 
months. 

3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

________________________________ 

(*) OJ L 324, 29.11.2002, p.1." 

(2) 

Article 9(1) is replaced by the following: 

"1. 

In order to take account of developments at international level, in particular in 
the 
the  International  Maritime  Organisation  (IMO),  and 
effectiveness  of  this  Regulation  in  the  light  of  experience  and  technical 
progress,  the  Commission  may  amend  the  definitions  in  Article  2  insofar  as 
such amendments do not broaden the scope of the Regulation. Those measures, 
designed to amend non-essential elements of this Regulation, shall be adopted 
in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 7(3)." 

improve 

to 

7.10.  Directive  2005/44/EC  of  the  European  Parliament  and  of  the  Council  of 
7 September  2005  on  harmonised  river  information  services  (RIS)  on  inland 
waterways in the Community52 

As regards Directive 2005/44/EC, power should in particular be conferred on the Commission 
to adapt the annexes to technical progress. Since those measures are of general scope and are 
designed to amend non-essential elements of Directive 2005/44/EC, they must be adopted in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 
1999/468/EC. 

Accordingly, Directive 2005/44/EC is amended as follows: 

(1) 

Article 10 is replaced by the following:  

52 

OJ L 255, 30.9.2005, p. 152. 

EN 

69 

   EN 

 
 
                                                 
"Article 10 

Amendment procedure 

Annexes  I  and  II  may  be  amended  in  the  light  of  the  experience  gained  from  the 
application  of  this  Directive  and  adapted  to  technical  progress.  Those  measures, 
designed  to  amend  non-essential  elements  of  this  Directive,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 11(4)." 

(2) 

Article 11 is replaced by the following:  

"Article 11 

Committee 

1. 

The Commission shall be assisted by the Committee instituted by Article 7 of 
Directive 91/672/EEC(*).  

2.  Where  reference  is  made  to  this  paragraph,  Articles  3  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

3.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.  

The  time  limit  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be 
three months. 

4.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

5. 

The Commission shall regularly consult representatives of the sector. 

____________________________ 

(*) OJ L 373, 31.12.1991, p. 29. " 

7.11.  Directive  2005/65/EC  of  the  European  Parliament  and  of  the  Council  of  26 

October 2005 on enhancing port security53 

As regards Directive 2005/65/EC, power should in particular be conferred on the Commission 
to adapt the Annexes. Since those measures are of general scope and are designed to amend 
non-essential elements of Directive 2005/65/EC, they must be adopted in accordance with the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Directive  2005/65/EC  lays  down  security  requirements  and  measures  and  is  based  on 
international instruments that are subject to amendment. On grounds of efficiency, the normal 

53 

OJ L 310, 25.11.2005, p. 28. 

EN 

70 

   EN 

 
                                                 
time limits for the regulatory procedure with scrutiny should be curtailed for the adaptation of 
its Annexes. 

Accordingly, Directive 2005/65/EC is amended as follows: 

(1) 

Articles 14 and 15 of Directive 2005/65/EC are replaced by the following: 

“Article 14 

Adaptations 

The Commission may amend Annexes I to IV without broadening the scope of this 
Directive.  Those  measures,  designed  to  amend  non-essential  elements  of  this 
Directive, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 15(2). 

Article 15 

Committee 

1. 

The Commission shall be assisted by the committee set up by Regulation (EC) 
No 725/2004. 

2.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

The  time  limits  laid  down  in  Article  5a(3)(c),  (4)(b)  and  (4)(e)  of 
Decision 1999/468/EC shall be one month.” 

EN 

71 

   EN 

 
(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

(15) 

Chronological index 

Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of 
the Member States relating to aerosol dispensers  (Page 9) 

Council  directive  79/373/EEC  of  2  April  1979  on  the  marketing  of  compound 
feeding stuffs 

(Page 44) 

Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in 
animal nutrition (Page 45) 

Council  Directive  82/883/EEC  of  3  December  1982  on  procedures  for  the 
surveillance and monitoring of environments concerned by waste from the titanium 
dioxide industry 

(Page 21) 

Council  Regulation  (EEC)  No  3821/85  of  20  December  1985,  as  last  amended,  on 
recording equipment in road transport 

(Page 58) 

Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, 
and in particular of the soil, when sewage sludge is used in agriculture  (Page 21) 

Council Regulation (EEC) No 3924/91 of 19 December 1991 on the establishment of 
a Community survey of industrial production 

(Page 34) 

Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions 
relating  to  the  placing  on  the  market  and  supervision  of  explosives  for  civil  uses

(Page 10) 

European  Parliament  and  Council  Directive  94/62/EC  of  20  December  1994  on 
packaging and packaging waste 

(Page 22) 

Council Directive 96/16/EC of 19 March 1996 on statistical surveys of milk and milk 
products 

(Page 36) 

Council  Directive  96/25/EC  of  29  April  1996  on  the  circulation  of  feed  materials, 
amending  Directives  70/524/EEC,  74/63/EEC,  82/471/EEC  and  93/74/EEC  and 
repealing Directive 77/101/EEC 

(Page 46) 

Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid 
(Page 8) 

Council  Directive  97/70/EC  of  11  December  1997  setting  up  a  harmonised  safety 
regime for fishing vessels of 24 metres in length and over 

(Page 59) 

Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur 
content of certain liquid fuels and amending Directive 93/12/EEC 

(Page 24) 

Council Directive 1999/35/EC  of  29  April  1999  on  a  system  of  mandatory  surveys 
for the safe operation of regular ro-ro ferry and high-speed passenger craft services

(Page 60) 

EN 

72 

   EN 

 
 
 
(16) 

(17) 

(18) 

(19) 

(20) 

(21) 

(22) 

(23) 

(24) 

(25) 

(26) 

(27) 

(28) 

Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 
on the approximation of the laws of the Member States relating to the noise emission 
in the environment by equipment for use outdoors (Page 11) 

Directive 2001/81/EC of the European Parliament and of the Council of 23 October 
2001 on national emission ceilings for certain atmospheric pollutants 

(Page 25) 

Directive  2001/109/EC  of  the  European  Parliament  and  of  the  Council  of 
19 December 2001 concerning the statistical surveys to be carried out by the Member 
States in order to determine the production potential of plantations of certain species 
of fruit trees  (Page 37) 

Regulation  (EC)  No  417/2002  of  the  European  Parliament  and  of  the  Council  of 
18 February 2002 on the accelerated phasing-in of double hull or equivalent design 
requirements  for  single  hull  oil  tankers  and  repealing  Council  Regulation  (EC)  No 
2978/94 

(Page 61) 

Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 
on undesirable substances in animal feed  (Page 48) 

Regulation  (EC)  No  91/2003  of  the  European  Parliament  and  of  the  Council  of 
16 December 2002 on rail transport statistics 

(Page 38) 

Regulation  (EC)  No  437/2003  of  the  European  Parliament  and  of  the  Council  of 
27 February  2003  on  statistical  returns  in  respect  of  the  carriage  of  passengers, 
freight and mail by air 

(Page 40) 

Regulation  (EC)  No  782/2003  of  the  European  Parliament  and  of  the  Council  of 
14 April 2003 on the prohibition of organotin compounds on ships 

(Page 62) 

Regulation  (EC)  No  998/2003  of  the  European  Parliament  and  of  the  Council  of 
26 May  2003  on  the  animal  health  requirements  applicable  to  the  non-commercial 
movements of pet animals and amending Council Directive 92/65/EEC. (Page 50) 

Regulation  (EC)  No  2003/2003  of  the  European  Parliament  and  of  the  Council  of 
13 October 2003 relating to fertilisers 

(Page 12) 

Directive 2003/87/EC of the European Parliament and of the Council of 13 October 
2003 establishing a scheme for greenhouse gas emission allowance trading within the 
Community and amending Council Directive 96/61/EC  (Page 25) 

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 
Page 
51) 

Regulation  (EC)  No  48/2004  of  the  European  Parliament  and  of  the  Council  of 
5 December  2003  on  the  production  of  annual  Community  statistics  on  the  steel 
industry for the reference years 2003-2009 (Page 42) 

EN 

73 

   EN 

 
(29) 

(30) 

(31) 

(32) 

(33) 

(34) 

(35) 

(36) 

(37) 

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 
2004 on the inspection and verification of good laboratory practice (GLP) (Codified 
version) 

(Page 13) 

Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 
February 2004 on drug precursors  (Page 15) 

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 
2004 on the harmonisation of laws, regulations and administrative provisions relating 
to the application of the principles of good laboratory practice and the verification of 
their applications for tests on chemical substances (codified version) 

(Page 14) 

Directive 2004/8/EC of the European Parliament and of the Council of 11 February 
2004 on the promotion of cogeneration based on a useful heat demand in the internal 
energy market and amending Directive 92/42/EC  (Page 64) 

Regulation  (EC)  No  648/2004  of  the  European  Parliament  and  of  the  Council  of 
31 March 2004 on detergents 

(Page 16) 

Regulation  (EC)  No  726/2004  of  the  European  Parliament  and  of  the  Council  of 
31 March  2004  laying  down  Community  procedures  for  the  authorisation  and 
supervision  of  medicinal  products  for  human  and  veterinary  use  and  establishing  a 
European Medicines Agency 

(Page 17) 

Regulation  (EC)  No  725/2004  of  the  European  Parliament  and  of  the  Council  of 
31 March 2004 on enhancing ship and port facility security 

(Page 66) 

Directive  2004/25/EC  of  the  European  Parliament  and  of  the  Council  of  21  April 
2004 on takeover bids 

(Page 43) 

Regulation  (EC)  No  789/2004  of  the  European  Parliament  and  of  the  Council  of 
21 April 2004 on the transfer of cargo and passenger ships between registers within 
the Community and repealing Council Regulation (EEC) No 613/91 

(Page 67) 

(38) 

Regulation  (EC)  No  850/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC

(Page 27) 

(39) 

(40) 

(41) 

Regulation  (EC)  No  852/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April 2004 on the hygiene of foodstuffs (Page 53) 

Regulation  (EC)  No  853/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April  2004  laying  down  specific  hygiene  rules  for  food  of  animal  origin

(Page 54) 

Regulation  (EC)  No  854/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April 2004 laying down specific rules for the organisation of official controls on 
products of animal origin intended for human consumption 

(Page 55) 

(42) 

Directive  2004/52/EC  of  the  European  Parliament  and  of  the  Council  of  29  April 
2004  on  the  interoperability  of  electronic  road  toll  systems  in  the  Community

(Page 65) 

EN 

74 

   EN 

 
 
 
 
(43) 

(44) 

(45) 

(46) 

(47) 

Directive  2004/107/EC  of  the  European  Parliament  and  of  the  Council  of 
15 December  2004  relating  to  arsenic,  cadmium,  mercury,  nickel  and  polycyclic 
aromatic hydrocarbons in ambient air 

(Page 29) 

Regulation  (EC)  No  183/2005  of  the  European  Parliament  and  of  the  Council  of 
12 January 2005 laying down requirements for feed hygiene 

(Page 56) 

Directive 2005/44/EC of the European Parliament and of the Council of 7 September 
2005  on  harmonised  river  information  services  (RIS)  on  inland  waterways  in  the 
Community  (Page 68) 

Directive 2005/65/EC of the European Parliament and of the Council of 26 October 
2005 on enhancing port security 

(Page 70) 

Regulation  (EC)  No  1013/2006  of  the  European  Parliament  and  of  the  Council  of 
14 June 2006 on shipments of waste 

(Page 31) 

EN 

75 

   EN