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 Four - Adaptation to the regulatory procedure with scrutiny
Date: 2008-02-11
Institutions: European Commission
Subjects: EU law, European Commission, Eurostat, consumer protection, domestic market, environmental law, powers of the institutions (EU), transport law

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.2.2008 
COM(2008) 71 final 

2008/0032 (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 Four 

(presented by the Commission) 

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TABLE OF CONTENTS 

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

1. 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

1.6. 

1.7. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

2.6. 

Enterprise ..................................................................................................................... 8 

Directive 97/68/EC of the European Parliament and of the Council of 16 December 
1997 on the approximation of the laws of the Member States relating to measures 
against the emission of gaseous and particulate pollutants from internal combustion 
engines to be installed in non-road mobile machinery................................................. 8 

Directive 98/79/EC of the European Parliament and of the Council of 27 October 
1998 on in vitro diagnostic medical devices ................................................................ 9 

Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 
on radio equipment and telecommunications terminal equipment and the mutual 
recognition of their conformity .................................................................................. 12 

Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 
December 1999 on orphan medicinal products.......................................................... 13 

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 
on the approximation of the laws, regulations and administrative provisions of the 
Member States relating to the implementation of good clinical practice in the conduct 
of clinical trials on medicinal products for human use .............................................. 14 

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 
2001 on the Community code relating to veterinary medicinal products .................. 16 

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 
2006 on machinery, and amending Directive 95/16/EC (recast) ............................... 18 

Environment............................................................................................................... 20 

Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated 
biphenyls and polychlorinated terphenyls.................................................................. 20 

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for 
human consumption ................................................................................................... 21 

Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 
June 2000 on substances that deplete the ozone layer ............................................... 22 

Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 
January 2006 concerning the establishment of a European Pollutant Release and 
Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC ..... 26 

Directive 2006/7/EC of the European Parliament and of the Council of 15 February 
2006 concerning the management of bathing water quality and repealing Directive 
76/160/EEC ................................................................................................................ 27 

Directive 2006/21/EC of the European Parliament and of the Council of 15 March 
2006 on the management of waste from extractive industries and amending Directive 
2004/35/EC ................................................................................................................ 28 

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3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

3.6. 

4. 

4.1. 

4.2. 

4.3. 

5. 

5.1. 

5.2. 

5.3. 

5.4. 

5.5. 

5.6. 

Eurostat ...................................................................................................................... 29 

Council Regulation (EC) No 2494/95 of 23 October 1995 concerning harmonized 
indices of consumer prices ......................................................................................... 29 

Council Regulation (EC) No 577/98 of 9 March 1998 on the organisation of a labour 
force sample survey in the Community ..................................................................... 31 

Council Regulation (EC) No 1165/98 of 19 May 1998 concerning short-term 
statistics ...................................................................................................................... 33 

Council Regulation (EC) No 530/1999 of 9 March 1999 concerning structural 
statistics on earnings and on labour costs .................................................................. 40 

Regulation (EC) No 450/2003 of the European Parliament and of the Council of 27 
February 2003 concerning the labour cost index ....................................................... 41 

Regulation EC) No 1552/2005 of the European Parliament and of the Council of 7 
September 2005 on statistics relating to vocational training in enterprises ............... 44 

Internal market ........................................................................................................... 46 

Regulation (EC) No 2195/2002 of the European Parliament and of the Council of 5 
November 2002 on the Common Procurement Vocabulary (CPV)........................... 46 

Directive 2004/17/EC of the European Parliament and of the Council of 31 March 
2004 coordinating the procurement procedures of entities operating in the water, 
energy, transport and postal services sectors ............................................................. 47 

Directive 2004/18/EC of the European Parliament and of the Council of 31 March 
2004 on the coordination of procedures for the award of public works contracts, 
public supply contracts and public service contracts ................................................. 50 

Health and Consumer Protection ............................................................................... 53 

Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community 
procedures for contaminants in food.......................................................................... 53 

Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for 
particular nutritional purposes.................................................................................... 54 

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain 
substances and residues thereof in live animals and products and repealing Directives 
85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC............. 55 

Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 
January 1997 concerning novel foods and novel food ingredients ............................ 58 

Decision 2119/98/EC of the European Parliament and of the Council of 24 
September 1998 setting up a network for the epidemiological surveillance and 
control of communicable diseases in the Community ............................................... 59 

Directive 2000/13/EC of the European Parliament and of the Council of 20 March 
2000 on the approximation of the laws of the Member States relating to the labelling, 
presentation and advertising of foodstuffs ................................................................. 61 

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5.7. 

5.8. 

5.9. 

Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 
on the approximation of the laws, regulations and administrative provisions of the 
Member States concerning the manufacture, presentation and sale of tobacco 
products ...................................................................................................................... 64 

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 
2001 on general product safety .................................................................................. 65 

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 
January 2002 laying down the general principles and requirements of food law, 
establishing the European Food Safety Authority and laying down procedures in 
matters of food safety................................................................................................. 67 

5.10.  Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 
October 2002 laying down health rules concerning animal by-products not intended 
for human consumption.............................................................................................. 68 

5.11.  Directive 2002/98/EC of the European Parliament and of the Council of 27 January 

2003 setting standards of quality and safety for the collection, testing, processing, 
storage and distribution of human blood and blood components and amending 
Directive 2001/83/EC................................................................................................. 76 

5.12.  Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 
September 2003 on additives for use in animal nutrition .......................................... 78 

5.13.  Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 
November 2003 on smoke flavourings used or intended for use in or on foods ....... 80 

5.14.  Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 
November 2003 on the control of salmonella and other specified food-borne zoonotic 
agents.......................................................................................................................... 81 

5.15.  Directive 2004/23/EC of the European Parliament and of the Council of 31 March 

2004 on setting standards of quality and safety for the donation, procurement, testing, 
processing, preservation, storage and distribution of human tissues and cells .......... 84 

5.16.  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 

April 2004 on official controls performed to ensure the verification of compliance 
with feed and food law, animal health and animal welfare rules............................... 86 

5.17.  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 
October 2004 on materials and articles intended to come into contact with food and 
repealing Directives 80/590/EEC and 89/109/EEC ................................................... 89 

6. 

6.1. 

6.2. 

Energy and Transport................................................................................................. 91 

Council Directive 96/98/EC of 20 December 1996 on marine equipment ................ 91 

Regulation (EC) 2099/2002 of the European Parliament and of the Council of 5 
November 2002 establishing a Committee on Safe Seas and the Prevention of 
Pollution from Ships (COSS) and amending the Regulations on maritime safety and 
the prevention of pollution from ships ....................................................................... 93 

6.3. 

Directive 2003/42/EC of the European Parliament and of the Council of 13 June 
2003 on occurrence reporting in civil aviation .......................................................... 94 

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6.4. 

6.5. 

6.6. 

6.7. 

Directive 2004/36/EC of the European Parliament and of the Council of 21 April 
2004 on the safety of third-country aircraft using Community airports .................... 95 

Regulation (EC) No 868/2004 of the European Parliament and of the Council of 21 
April 2004 concerning protection against subsidisation and unfair pricing practices 
causing injury to Community air carriers in the supply of air services from countries 
not members of the European Community ................................................................ 97 

Directive 2004/54/EC of the European Parliament and of the Council of 29 April 
2004 on minimum safety requirements for tunnels in the Trans-European Road 
Network...................................................................................................................... 98 

Regulation (EC) No 2111/2005 of the European Parliament and of the Council of 14 
December 2005 on the establishment of a Community list of air carriers subject to an 
operating ban within the Community and on informing air transport passengers of the 
identity of the operating air carrier, and repealing Article 9 of Directive 2004/36/EC
.................................................................................................................................... 99 

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2008/0032 (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 Four 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION 

Having regard to the Treaty establishing the European Community, and in particular Articles 
47(2), 55, 71(1), 80(2), 95, 152(4)(a) and (b), 175(1), and 285(1) 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. 

(2) 

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 

1 
2 
3 
4 
5 

6 

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). 
OJ C 255, 21.10.2006, p. 1. 

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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. 

(3) 

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 
[…] 

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ANNEX  

1. 

ENTERPRISE 

1.1. 

Directive  97/68/EC  of  the  European  Parliament  and  of  the  Council  of  16 
December 1997 on the approximation of the laws of the Member States relating 
to  measures  against  the  emission  of  gaseous  and  particulate  pollutants  from 
internal combustion engines to be installed in non-road mobile machinery7  

As regards Directive 97/68/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 97/68/EC is amended as follows: 

(1) 

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

“The Commission shall amend Annex VIII. 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) 

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

“The  Commission  shall  adapt  Annex  VII  to  integrate  the  additional  and  specific 
information  which  may  be  required  as  regards  the  type  approval  certificate  for 
engines  to  be  installed  in  inland  waterway  vessels.  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).” 

(3) 

Article 14 is replaced by the following: 

“Article 14 

The  Commission  shall  adopt  any  amendments  which  are  necessary  to  adapt  the 
Annexes, with the exception of the requirements specified in section 1, sections 2.1 
to 2.8 and section 4 of Annex I, to the 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 15(2).” 

(4) 

Article 14a is replaced by the following: 

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OJ L 59, 27.2.1998, p.1.  

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“Article 14a 

The  Commission  shall  study  possible  technical  difficulties  in  complying  with  the 
stage II requirements for certain uses of the engines, in particular mobile machinery 
in which engines of classes SH:2 and SH:3 are installed. If the Commission studies 
conclude  that  for  technical  reasons  certain  mobile  machinery,  in  particular, 
professional use, multi-positional, hand-held engines, cannot meet these deadlines, it 
shall submit, by 31 December 2003, a report accompanied by appropriate proposals 
for  extensions  of  the  period  referred  to  in  Article  9a(7)  and/or  further  derogations, 
not exceeding five years, unless in exceptional circumstances, for such machinery. 

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 15(2).” 

(5) 

Article 15 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) 

In Annex I, point 4.1.2.7, the last sentence is replaced by the following: 

“The  Commission  shall  define  the  control  area  to  which  the  percentage  not  to  be 
exceeded shall apply and the excluded engine operating conditions. 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).” 

(7) 

In Annex III, the last paragraph of point 1.3.2 is replaced by the following: 

“Prior  to  the  introduction  of  the  cold/hot  composite  test  sequence,  the  Commission 
shall modify the symbols (Annex I, section 2.18) the test sequence (Annex III) and 
calculation equations (Annex III, Appendix III). 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).” 

1.2. 

Directive  98/79/EC  of  the  European  Parliament  and  of  the  Council  of  27 
October 1998 on in vitro diagnostic medical devices8 

As regards Directive 98/79/EC, power should in particular be conferred on the Commission to 
adopt  common  technical  specifications  to  establish  appropriate  performance  evaluation  and 
re-evaluation criteria, batch release criteria, reference methods and reference materials, and to 
adopt  particular  health  monitoring  measures,  and  to  amend  Annex  II.  Since  those  measures 
are  of  general  scope  and  are  designed  to  amend  or  supplement  non-essential  elements  of 

8 

OJ L 331, 7.12.1998, p. 1.  

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Directive 98/79/EC, 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  should  be  able  to  use  the  urgent 
procedure  provided  for  in  Article  5a(6)  of  Decision  1999/468/EC  for  the  adoption  of 
prohibitions, restrictions or particular requirements for certain products. 

Accordingly, Directive 98/79/EC is amended as follows: 

(1) 

In Article 5(3), the second subparagraph is replaced by the following: 

“The Commission shall lay down the common technical specifications which shall be 
published in the Official Journal of the European Union. 

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).” 

(2) 

Article 7 is replaced by the following: 

“Article 7 

1. 

The Commission shall be assisted by the Committee set up by Article 6(2) of 
Directive 90/385/EEC (hereinafter referred to as “the Committee”). 

2.  Where  reference 

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

is  made 

to 

The  period  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be  set  a 

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. 

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.” 

(3) 

Article 10(5) is replaced by the following: 

“5.  The  Member  States  shall  take  all  necessary  measures  to  ensure  that  the 
notifications referred to in paragraphs 1 and 3 are registered immediately in the 
databank described in Article 12.  

The procedures for implementing this Article and in particular those referring to the 
notification  and  the  concept  of  significant  change  shall  be  adopted  in 
accordance with the regulatory procedure referred to in Article 7 (2).” 

(4) 

Article 11(5) is replaced by the following: 

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“5.  The  Member  States  shall  on  request  inform  the  other  Member  States  of  the 
details  referred  to  in  paragraphs  1  to  4.  The  procedures  implementing  this 
Article shall be adopted in accordance with the regulatory procedure referred to 
in Article 7(2).” 

(5) 

Article 12(3) is replaced by the following: 

“3.  The procedures implementing this Article shall be adopted in accordance with 

the regulatory procedure referred to in Article 7(2).” 

(6) 

Article 13 is replaced by the following: 

“Article 13 

Where a Member State considers, in relation to a given product or group of products, 
that,  in  order  to  ensure  protection  of  health  and  safety  and/or  to  ensure  that  public 
health requirements are observed pursuant to Article 36 of the Treaty, the availability 
of  such  products  should  be  prohibited,  restricted  or  made  subject  to  particular 
requirements, it  may take any necessary and justified transitional measures. It shall 
then inform the Commission and all the other Member States, giving the reasons for 
its  decision.  The  Commission  shall  consult  the  interested  parties  and  the  Member 
States  and,  where  the  national  measures  are  justified,  adopt  necessary  Community 
measures.  

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).  On  imperative  grounds  of  urgency,  the 
Commission may use the urgent procedure referred to in Article 7(4).” 

(7) 

Article 14(1) is replaced by the following: 

“1.  Where a Member State considers either of the following it shall submit a duly 
substantiated  request  to  the  Commission  and  ask  it  to  take  the  necessary 
measures: 

(a) 

that the list of devices in Annex II should be amended or extended;  

(b) 

that  the  conformity  of  a  device  or  category  of  devices  should  be 
established,  by  way  of  derogation  from  the  provisions  of  Article  9,  by 
applying  one  or  more  given  procedures  taken  from  amongst  those 
referred to in Article 9.  

The measures referred to in point (a) of this paragraph, 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). 

The Commission shall, in accordance with the procedure referred to in Article 
7(2) adopt the measures referred to in point (b) of this paragraph.” 

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1.3. 

Directive 1999/5/EC of the European Parliament and of the Council of 9 March 
1999 on radio equipment and telecommunications terminal equipment and the 
mutual recognition of their conformity9  

As regards Directive 1999/5/EC, power should in particular be conferred on the Commission 
to adopt a decision specifying, for apparatus within certain equipment classes or apparatus of 
particular  types,  which  of  the  additional  requirements  apply,  to  determine  the  date  of 
application, including, where appropriate, a transitional period, of certain additional essential 
requirements to specific equipment classes or apparatus of particular types, and to decide on 
the form of the equipment class identifier to be affixed on specific types of radio equipment. 
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 1999/5/EC is amended as follows: 

(1) 

Article 3(3) is replaced by the following: 

“3.  The Commission may decide that apparatus within certain equipment classes or 

apparatus of particular types shall be so constructed that: 

(a) 

(b) 

it  interworks  via  networks  with  other  apparatus  and  that  it  can  be 
connected 
the 
Community; and/or that 

the  appropriate 

interfaces  of 

throughout 

type 

to 

it  does  not  harm  the  network  or  its  functioning  nor  misuse  network 
resources, thereby causing an unacceptable degradation of service; and/or 
that 

(c) 

it incorporates safeguards to ensure that the personal data and privacy of 
the user and of the subscriber are protected; and/or that 

(d) 

it supports certain features ensuring avoidance of fraud; and/or that 

(e) 

(f) 

it supports certain features ensuring access to emergency services; and/or 
that 

it  supports  certain  features  in  order  to  facilitate  its  use  by  users  with  a 
disability. 

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 6(2) is replaced by the following: 

“2. 

In taking a decision  regarding the application of essential requirements  under 
Article  3(3),  the  Commission  shall  determine  the  date  of  application  of  the 
requirements.  

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OJ L 91, 7.4.1999, p.10.  

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If it is determined that an equipment class needs to comply with particular essential 
requirements  under  Article  3(3),  any  apparatus  of  the  equipment  class  in 
question  which  is  first  placed  on  the  market  before  the  date  of  application  of 
the Commission's determination can continue to be placed on the market for a 
reasonable period. 

The  measures  referred  to  in  the  first  and  second  subparagraphs,  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 15.” 

(3) 

Article 15 is replaced by the following:  

“Article 15 

Regulatory procedure with scrutiny 

Where  reference  is  made  to  this  Article,  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) 

Point 5 of Annex VII is replaced by the following: 

“5.  The  equipment  class  identifier  must  take  a  form  to  be  decided  by  the 

Commission.  

Those  measures,  designed  to  amend  non-essential  elements  oft  this  Directive  by 
supplementing  it,  shall  be  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 15.” 

1.4. 

Regulation (EC) No 141/2000 of the European Parliament and of the Council of 
16 December 1999 on orphan medicinal products10  

As regards Regulation (EC) No 141/2000 power should be conferred on the Commission to 
adopt definitions of ‘similar medicinal product’ and ‘clinical superiority’. Since this measure 
is of general scope and is designed to amend non-essential elements of that Regulation or to 
supplement its elements, it 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 141/2000 is amended as follows:  

(1) 

Article 3(2) is replaced by the following:  

“2.  The Commission shall, in accordance with the procedure referred to in Article 
10a(2),  adopt  the  necessary  provisions  for  implementing  paragraph  1  of  this 
Article in the form of an implementing Regulation.” 

(2) 

Article 5(8) is replaced by the following: 

10 

OJ L 18, 22.1.2000, p. 1 

EN 

13 

   EN 

 
                                                 
“8.  The Agency shall forthwith forward the final opinion of the Committee to the 
Commission,  which  shall  adopt  a  decision  within  30  days  of  receipt  of  the 
opinion.  Where,  in  exceptional  circumstances,  the  draft  decision  is  not  in 
accordance with the opinion of the Committee, the decision shall be adopted in 
accordance with the procedure referred to in Article 10a(2). The decision shall 
be  notified  to  the  sponsor  and  communicated  to  the  Agency  and  to  the 
competent authorities of the Member States.” 

(3) 

Article 8(4) is replaced by the following: 

“4.  The  Commission  shall  adopt  definitions  of  ‘similar  medicinal  product’  and 

‘clinical superiority’ in the form of an implementing 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 10a(3).” 

(4) 

The following Article 10a is inserted: 

“Article 10a 

1. 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Medicinal 
Products for Human Use. 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 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.” 

1.5. 

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 
2001  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions of the Member States relating to the implementation of good clinical 
practice in the conduct of clinical trials on medicinal products for human use11 

As regards Directive 2001/20/EC power should in particular be conferred on the Commission 
to lay down specific requirements and to adapt certain provisions. Since those measures are of 
general  scope  and  are  designed  to  amend  non-essential  elements  of  that  Directive  and  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. 

Directive 2001/20/EC is amended as follows:  

(1) 

Article 13(1) is replaced by the following:  

11 

OJ L 121, 1.5.2001, p. 34. 

EN 

14 

   EN 

                                                 
“1.  Member  States  shall  take  all  appropriate  measures  to  ensure  that  the 
manufacture or importation of investigational medicinal products is subject to 
the holding of authorisation.  

The  Commission  shall  lay  down  the  requirements  which  the  applicant  and, 
subsequently,  the  holder  of  the  authorisation  must  at  least  meet  in  order  to 
obtain the authorisation.  

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).”  

(2) 

Article 20 is replaced by the following:  

“Article 20 

The Commission shall adapt this Directive to take account of 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 21(3).”  

(3) 

Article 21 is replaced by the following:  

“Article 21 

1. 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Medicinal 
Products for Human Use, referred to in Article 121(1) of Directive 2001/83/EC 
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 period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three 

months. 

3.  Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of 
Decision  No  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of 
Article 8 thereof. 

_____________________________________ 

(*) OJ L 311, 28.11.2001, p. 67”.  

EN 

15 

   EN 

1.6. 

Directive  2001/82/EC  of  the  European  Parliament  and  of  the  Council  of  6 
November  2001  on  the  Community  code  relating  to  veterinary  medicinal 
products12 

As regards Directive 2001/82/EC power should in particular be conferred on the Commission 
to  adapt  certain  provisions  and  annexes,  and  to  lay  down  specific  conditions  of  application. 
Since those measures are of general scope and are designed to amend non-essential elements 
of that Directive and/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 2001/82/EC is amended as follows:  

(1) 

Article 10(3) is replaced by the following: 

“3.  By way of derogation from Article 11, the Commission shall establish a list of 
substances essential for the treatment of equidae and for which the withdrawal 
period shall be not less than  six months according  to the control mechanisms 
laid down in Decisions 93/623/EEC and 2000/68/EC. 

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 89(2a).” 

(2) 

In Article 11(2), the third subparagraph is replaced by the following: 

“However,  the  Commission  may  modify  these  specific  withdrawal  periods.  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 89(2a).” 

(3) 

In Article 13(1), the fourth subparagraph is replaced by the following: 

“However,  the  ten-year  period  provided  for  in  the  second  subparagraph  shall  be 
extended to 13 years in the case of veterinary medicinal products for fish or bees or 
other species designated 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 89(2a).” 

(4) 

In Article 17(1), the second subparagraph is replaced by the following: 

“If it appears justified in the light of new scientific evidence, the Commission may 
adapt  points  (b)  and  (c)  of  the  first  subparagraph.  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 89(2a).” 

(5) 

In Article 39(1), the third subparagraph is replaced by the following: 

12 

OJ L 311, 28.11.2001, p. 1. 

EN 

16 

   EN 

 
                                                 
“The  Commission  shall  adopt  these  arrangements  in  the  form  of  an  implementing 
regulation. That regulation, a 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 89(2a).” 

(6) 

Article 50a(2) is replaced by the following: 

“2.  The  Commission  shall  adopt  any  amendments  which  may  be  necessary  to 
adapt the provisions of Paragraph 1 to take account of 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 89(2a).” 

(7) 

In Article 51, the first paragraph is replaced by the following: 

“The  principles  and  guidelines  of  good  manufacturing  practice  for  veterinary 
medicinal products referred to in Article 50(f) shall be adopted by the Commission in 
the form of a Directive addressed to the Member States. 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 
89(2a).” 

(8) 

In Article 67, point (aa) is replaced by the following: 

“(aa) veterinary medicinal products for food-producing animals. 

However, Member States may grant exemptions from this requirement according to 
criteria established by the Commission. The establishment of those criteria, 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 89(2a). 

Member States may continue to apply national provisions until either: 

(i) 

the  date  of  application  of  the  decision  adopted  in  accordance  with  the  first 
subparagraph; or 

(ii)  1 January 2007, if no such decision has been adopted by 31 December 2006;” 

(9) 

Article 68(3) is replaced by the following: 

“3.  The Commission shall adopt any amendments to the list of substances referred 

to in paragraph 1. 

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 89(2a).” 

(10) 

Article 75(6) is replaced by the following: 

EN 

17 

   EN 

 
 
“6.  The Commission may amend paragraph 5 in the light of the experience gained 

from its operation.  

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 89(2a).” 

(11) 

Article 79 is replaced by the following: 

“Article 79 

The  Commission  shall  adopt  any  amendments  which  may  be  necessary  to  update 
Articles 72 to 78 to take account of 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 89(2a).” 

(12) 

Article 88 is replaced by the following: 

“Article 88 

The  Commission  shall  adopt  any  changes  which  are  necessary  in  order  to  adapt 
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 89(2a).” 

(13) 

Article 89 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 No 1999/468/EC shall apply, having regard to the 
provisions of Article 8 thereof”.  

(b)  Paragraph 4 is replaced by the following: 

“4.  The rules of procedure of the Standing Committee shall be made public.” 

1.7. 

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 
2006 on machinery, and amending Directive 95/16/EC (recast)13 

As regards Directive 2006/42/EC, power should in particular be conferred on the Commission 
to  establish  the  conditions  for  updating  the  indicative  list  of  safety  components  and  for  the 
measures  regarding  the  restriction  of  the  placing  on  the  market  of  potentially  hazardous 
machinery.  Since  those  measures  are  of  general  scope  and  are  designed  to  amend  non-

13 

OJ L 157, 9.6.2006, p.24. 

EN 

18 

   EN 

                                                 
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 2006/42/EC is amended as follows: 

(1) 

Article 8(1) is replaced by the following: 

“1.  The Commission may take any appropriate measure relating to the following: 

(a) 

(b) 

updating of the indicative list of safety components in Annex V referred 
to in point (c) of Article 2; 

the  restriction  of  the  placing  on  the  market  of  machinery  referred  to  in 
Article 9. 

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 22(3).” 

(2) 

Article 9(3) is replaced by the following: 

“3. 

In  the  cases  referred  to  in  paragraph  1,  the  Commission  shall  consult  the 
Member States and other interested parties indicating the measures it intends to 
take, in order to ensure, at Community level, a high level of protection of the 
health and safety of persons. 

Taking  due  account  of  the  results  of  this  consultation,  it  shall  adopt  the 
necessary measures. 

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 22(3).” 

(3) 

Article 22 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)  paragraph (4) is deleted. 

EN 

19 

   EN 

2. 

ENVIRONMENT 

2.1. 

Council  Directive  96/59/EC  of  16  September  1996  on  the  disposal  of 
polychlorinated biphenyls and polychlorinated terphenyls14 

As  regards  Directive  96/59/EC,  power  should  in  particular  be  conferred  on  the 
Commission  to  fix  the  reference  methods  of  measurement  to  determine  the  PCB 
content of contaminated materials and the technical standards for the other methods 
of  disposing  of  PCBs,  and,  if  necessary,  to  determine,  solely  for  the  purpose  of 
Article  9(1)(b)  and  (c)  other  less  hazardous  substitutes  for  PCBs.  Since  those 
measures are of general scope and are designed to supplement Directive 96/59/EC 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 96/59/EC is amended as follows: 

(1) 

Article 10 is replaced by the following: 

“Article 10 

1. 

The Commission shall, in accordance with the procedure referred to in Article 
10a(2),  make  available  a  list  of  the  production  names  of  capacitors,  resistors 
and inductance coils, containing PCBs.  

2. 

The Commission shall:  

(a) 

fix the reference methods of measurement to determine the PCB content 
of  contaminated  materials.  Measurements  effected  before 
the 
determination of the reference methods shall remain valid; 

(b) 

if  necessary  determine,  solely  for  the  purpose  of  points  (b)  and  (c  )  of 
Article 9(1) other less hazardous substitutes for PCBs.  

The  Commission  may  fix  technical  standards  for  the  other  methods  of 
disposing of PCBs referred to in the second sentence of Article 8(2). 

The  measures  referred  to  in  the  first  and  second  subparagraphs,  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 10a(3)”. 

(2) 

The following Article 10a is inserted: 

“Article 10a 

1. 

The  Commission  shall  be  assisted  by  the  Committee  set  up  by  Article  18  of 
Directive 2006/12/EC (*), hereinafter referred to as 'the Committee'. 

14 

OJ L 243, 24.9.1996, p. 31. 

EN 

20 

   EN 

                                                 
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. 

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” 

2.2. 

Council  Directive  98/83/EC  of  3  November  1998  on  the  quality  of  water 
intended for human consumption15 

As  regards  Directive  98/83/EC,  power  should  in  particular  be  conferred  on  the 
Commission to adapt Annexes II and III to scientific and technical progress and to 
set out certain details on monitoring in Annex II. Since those measures are of general 
scope and are designed to amend non-essential elements of Directive 98/83/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 98/83/EC is amended as follows: 

(1) 

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

"4.  Community  guidelines  for  the  monitoring  prescribed  in  this  Article  may  be 
drawn up in accordance with the procedure referred to in Article 12(2)." 

(2) 

In Article 11, paragraph 2 is replaced by the following: 

"2.  At  least  every  five  years,  the  Commission  shall  amend  Annexes  II  and  III  to 

make the necessary adaptations 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 12(3)." 

(3) 

In Article 12, 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 13, paragraph 4 is replaced by the following: 

"4.  The  formats  and  the  minimum  information  for  the  reports  provided  for  in 
paragraph 2 shall be determined having special regard to the measures referred 
to in Article 3(2), Article 5(2) and (3), Article 7(2), Article 8, Article 9(6) and 
(7)  and  15(1),  and  shall  if  necessary  be  amended  in  accordance  with  the 
procedure referred to in Article 12(2)." 

15 

OJ L 330, 5.12.1998, p. 32  

EN 

21 

   EN 

                                                 
(5) 

In Article 13, paragraph 6 is replaced by the following: 

"6.  Together  with  the  first  report  on  this  Directive  as  mentioned  in  paragraph  2, 
Member States shall also produce a report to be forwarded to the Commission 
on  the  measures  they  have  taken  or  plan  to  take  to  fulfil  their  obligations 
pursuant  to  Article  6(3)  and  Annex  I,  Part  B,  note  10.  As  appropriate,  a 
proposal on the format of this report shall be submitted in accordance with the 
procedure referred to in Article 12(2)." 

(6) 

In Article 15, paragraph 3 is replaced by the following: 

"3.  That request shall be examined in accordance with the procedure referred to in 

Article 12(2)." 

(7) 

In Annex I, Part C, note 10 point 1 is replaced by the following: 

"The  Commission  shall  adopt  the  measures  required  under  Note  8  on  monitoring 
frequencies, and Note 9 on monitoring frequencies, monitoring methods and the most 
relevant  locations  for  monitoring  points  in  Annex  II.  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).  

When elaborating these measures the Commission shall take into account inter alia 
the  relevant  provisions  under  existing  legislation  or  appropriate  monitoring 
programmes including monitoring results as derived from them." 

(8) 

In Annex III, paragraph 1, the first subparagraph is replaced by the following:  

"The following principles for methods of microbiological parameters are given either 
for  reference  whenever  a  CEN/ISO  method  is  given  or  for  guidance,  pending  the 
possible  future  adoption,  by  the  Commission,  of  further  CEN/ISO  international 
methods  for  these  parameters.  Member  States  may  use  alternative  methods, 
providing the provisions of Article 7(5) are met. 

Those measures on further CEN/ISO international methods, 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 12(3)." 

2.3. 

Regulation (EC) No 2037/2000 of the European Parliament and of the Council 
of 29 June 2000 on substances that deplete the ozone layer16 

As regards Regulation (EC) No 2037/2000, power should in particular be conferred 
on the Commission to amend Annex VI; to establish and reduce the calculated level 
of  methyl  bromide  that  can  be  placed  on  the  market  or  used  by  importers  or 
producers  for  their  own  account  for  Quarantine  and  Pre-Shipment  purpose;  to 
determine a mechanism for the allocation of quotas of the calculated levels of methyl 
bromide  to  each  producer  and  importer;  to  adopt,  if  necessary,  modifications  and, 
where appropriate, time-frames  for phase-out of the critical uses of halons listed in 
Annex VII; to take a decision on whether to adapt the end date of prohibition of the 

16 

OJ L 244, 29.9.2000, p. 1. 

EN 

22 

   EN 

                                                 
use of hydrochlorofluorocarbons; to modify the list and dates with regards to control 
of  the  use  of  hydrochlorofluorocarbons;  to  modify  the  list  of  items  related  to  the 
request of an import license and Annex IV, to amend the list of products containing 
controlled  substances  and  of  Combined  Nomenclature  codes  in  Annex  V;  and  to 
advance the date of export prohibition of recovered, recycled and reclaimed halon for 
critical uses, and to modify the reporting requirements. Since those measures are of 
general scope and are designed to amend non-essential elements of Regulation (EC) 
No 2037/2000 and to supplement Regulation (EC) No 2037/2000 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 2037/2000 is amended as follows: 

(1) 

In Article 2, the 16th indent on "processing agent" is replaced by the following: 

“- 'processing agent' means controlled substances used as chemical processing agents 
in  those  applications  listed  in  Annex  VI,  in  installations  existing  at  1  September 
1997,  and  where  emissions  are  insignificant  The  Commission  shall,  in  the  light  of 
those  criteria,  and  in  accordance  with  the  procedure  referred  to  in  Article  18(2), 
establish  a  list  of  undertakings  in  which  the  use  of  controlled  substances  as 
processing agents shall be permitted, laying down maximum emission levels for each 
of the undertakings concerned. 

In  the  light  of  new  information  or  technical  developments,  including  the  review 
provided  for  in  Decision  X/14  of  the  Meeting  of  the  Parties  to  the  Protocol,  the 
Commission may: 

(a) 

(b) 

amend  the  list  of  undertakings  referred  to  above  in  accordance  with  the 
procedure referred to in Article 18(2);  

amend Annex VI. 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 18(3)." 

(3) 

Article 4 is amended as follows: 

(a) 

in paragraph 2 the third subparagraph of point (iii) is replaced by the following: 

“The Commission shall take measures to reduce the calculated level of methyl 
bromide  which  producers  and  importers  may  place  on  the  market  or  use  for 
their own account for quarantine and preshipment in the light of technical and 
economic  availability  of  alternative  substances  or  technologies,  and  of  the 
relevant  international  developments  under  the  Protocol.  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 18(3).” 

(b) 

in paragraph 3, point (ii) is replaced by the following: 

"(ii)  The Commission may amend the mechanism for the allocation of quotas 
to each producer and importer of the calculated levels set out in (d) to (f), 

EN 

23 

   EN 

applicable  for  the  period  1  January  2003  to  31  December  2003  and  for 
each 12 month period thereafter. 

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 18(3).” 

(c) 

in paragraph 4, point (iv) is replaced by the following: 

"(iv)  Paragraph  1(c)  shall  not  apply  to  the  placing  on  the  market  and  use  of 
halons  that  have  been  recovered,  recycled  or  reclaimed  in  existing  fire 
protection  systems  until  31  December  2002  or  to  the  placing  on  the 
market and use of halons for critical uses as set out in Annex VII. Each 
year  the  competent  authorities  of  the  Member  States  shall  notify  to  the 
Commission the quantities of halons used for critical uses, the measures 
taken  to  reduce  their  emissions  and  an  estimate  of  such  emissions,  and 
the current activities to identify and use adequate alternatives. 

Each  year  the  Commission  shall  review  the  critical  uses  listed  in  Annex  VII 
and,  if  necessary,  adopt  modifications  and,  where  appropriate,  time-
frames  for  phase-out,  taking  into  account  the  availability  of  both, 
technically  and  economically  feasible  alternatives  or  technologies  that 
are acceptable from the standpoint of environment and health. 

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 18(3).” 

(4) 

Article 5 is amended as follows: 

(a) 

In  paragraph  1,  the  fifth  subparagraph  of  point  (c)(v),  is  replaced  by  the 
following: 

“The  Commission  shall  submit  the  result  of  the  review  to  the  European 
Parliament  and  to  the  Council.  It  shall,  as  appropriate,  take  a  decision  on 
whether to adapt the date of 1 January 2015. 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 18(3).” 

(b)  paragraph 6 is replaced by the following: 

“6.  The  Commission  may,  in  the  light  of  experience  with  the  operation  of  this 
Regulation or to reflect technical progress, amend the list and the dates set out 
in  paragraph  1  but  in  no  case  extend  the  periods  set  out  therein,  without 
prejudice to the exemptions provided for in paragraph 7. 

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 18(3).” 

(5) 

Article 6(5) is replaced by the following: 

EN 

24 

   EN 

 
 
“5.  The  Commission  may  amend  the  list  of  items  mentioned  in  paragraph  3  and 

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 18(3).”  

(6) 

Article 9 (2) is replaced by the following: 

“2.  A  list  of  products  containing  controlled  substances  and  of  Combined 
Nomenclature codes is given in Annex V for guidance of the Member States' 
customs authorities. The Commission may add to, delete items from or amend 
that list in the light of the lists established by the Parties. 

 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 18(3).” 

(7)  Article 11(1), point (d) is replaced by the following: 

“(d)  recovered,  recycled  and  reclaimed  halon  stored  for  critical  uses  in  facilities 
authorised or operated by the competent authority to satisfy critical uses listed 
in Annex VII until 31 December 2009, and products and equipment containing 
halon  to  satisfy  critical  uses  listed  in  Annex  VII.  Following  a  review 
undertaken  by  1  January  2005  by  the  Commission  of  exports  of  such 
recovered, recycled and reclaimed halon for critical uses the Commission may 
prohibit such exports earlier than 31 December 2009. That 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 18(3).”  

(8) 

In Article 18, 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." 

(9) 

In Article 19, paragraph 6 is replaced by the following: 

"6.  The  Commission  may  amend  the  reporting  requirements  laid  down  in 
paragraphs 1 to 4 to meet commitments under  the Protocol  or  to  improve the 
practical application of those reporting requirements. 

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 18(3).”  

EN 

25 

   EN 

 
2.4. 

Regulation (EC) No 166/2006 of the European Parliament and of the Council of 
18 January 2006 concerning the establishment of a European Pollutant Release 
and  Transfer  Register  and  amending  Council  Directives  91/689/EEC  and 
96/61/EC17  

As regards Regulation (EC) No 166/2006, power should in particular be conferred on 
the Commission to adopt measures referred to in Article 8(3); to adapt Annexes II or 
III to this Regulation to scientific or technical progress; and to adapt Annexes II and 
III to this Regulation as a result of the adoption by the Meeting of the Parties to the 
UNECE Protocol on Pollutant Release and Transfer Registers of any amendment to 
the  Annexes  to  this  Protocol.  Since  those  measures  are  of  general  scope  and  are 
designed  to  amend  non-essential  elements  of  Regulation  (EC)  No  166/2006  and  to 
supplement  Regulation  (EC)  No  166/2006  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 166/2006 is amended as follows: 

(1) 

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

"3.  Where  the  Commission  determines  that  no  data  on  the  releases  from  diffuse 
sources  exist,  measures  to  initiate  reporting  on  releases  of  relevant  pollutants 
from  one  or  more  diffuse  sources  shall  be  taken  using,  where  appropriate, 
internationally approved methodologies. 

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 19(3)." 

(2) 

Article 18 is replaced by the following:  

"Article 18 

Amendments to the Annexes 

The  Commission  shall  make  the  necessary  amendments  to  the  annexes  for  the 
following purposes: 

(a) 

the adaptation of Annexes II or III to scientific or technical progress;  

(b) 

the adaptation of Annexes II and III as a result of the adoption by the Meeting 
of the Parties to the Protocol of any amendment to the Annexes to the Protocol. 

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 19(3)."  

(3) 

In Article 19, the following paragraph 3 is added: 

17 

OJ L 33, 4.2.2006, p. 1. 

EN 

26 

   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." 

2.5. 

Directive  2006/7/EC  of  the  European  Parliament  and  of  the  Council  of 
15 February  2006  concerning  the  management  of  bathing  water  quality  and 
repealing Directive 76/160/EEC18 

As  regards  Directive  2006/7/EC,  power  should  in  particular  be  conferred  on  the 
Commission to adapt, in the light of scientific and technical progress, the methods of 
analysis  for  the  parameters  and  sampling  rules  set  out  in  Annex  I  and  Annex  V 
respectively,  and 
the  equivalence  of 
microbiological  methods.  Since  those  measures  are  of  general  scope  and  are 
designed to amend non-essential elements of Directive 2006/7/EC and 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. 

the  EN/ISO  standard  on 

to  specify 

Accordingly, Directive 2006/7/EC is amended as follows: 

(1) 

Article 15 is replaced by the following: 

“Article 15 

"1.  The Commission shall, in accordance with the procedure referred to in Article 

16(2), lay down the following: 

(a) 

detailed rules for the implementation of Article 8(1), Article 12(1)(a) and 
Article 12(4); 

(b)  guidelines for a common method for the assessment of single samples." 

2. 

The Commission shall adopt the following measures: 

(a) 

(b) 

the  specification  of  EN/ISO  standard  on 
microbiological methods for the purposes of Article 3(9);  

the  equivalence  of 

any  amendments  necessary  to  adapt  the  methods  of  analysis  for  the 
parameters  set  out  in  Annex  I  in  the  light  of  scientific  and  technical 
progress;  

(c) 

any amendments necessary to adapt Annex V in the light of scientific and 
technical progress. 

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 16(3)". 

(2) 

In Article 16, paragraph 3 is replaced by the following: 

18 

OJ L 64, 4.3.2006, p. 3. 

EN 

27 

   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." 

2.6. 

Directive  2006/21/EC  of  the  European  Parliament  and  of  the  Council  of  15 
March  2006  on  the  management  of  waste  from  extractive  industries  and 
amending Directive 2004/35/EC19 

As  regards  Directive  2006/21/EC,  power  should  in  particular  be  conferred  on  the 
Commission to adopt provisions necessary for the implementation of Article 13(6), 
to complete the technical requirements for waste characterisation contained in Annex 
II,  to  interpret  the  definition  in  point  3  of  Article  3,  to  define  the  criteria  for  the 
classification  of  waste  facilities  in  accordance  with  Annex  III,  to  determine 
harmonised standards for sampling and analysis methods, and to adapt the Annexes 
to  scientific  and  technical  progress.  Since  those  measures  are  of  general  scope  and 
are  designed  to  amend  non-essential  elements  of  Directive  2006/21/EC  and  to 
supplement  Directive  2006/21/EC  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 2006/21/EC is amended as follows:  

(1) 

Article 22 is replaced by the following: 

“Article 22 

1. 

By  1  May  2008,  the  Commission  shall,  in  accordance  with  the  procedure 
referred to in Article 23(2), adopt the following: 

(a) 

(b) 

provisions  necessary  for  the  harmonisation  and  regular  transmission  of 
the information referred to in Article 7(5) and Article12(6);  

technical  guidelines  for  the  establishment  of  the  financial  guarantee  in 
accordance with the requirements of Article 14(2); 

(c) 

technical guidelines for inspections in accordance with Article 17. 

2. 

By 1 May 2008, the Commission shall lay down provisions necessary for the 
following, prioritising (b), (c) and (d): 

(a) 

the  implementation  of  Article  13(6),  including  technical  requirements 
relating  to  the  definition  of  weak  acid  dissociable  cyanide  and  its 
measurement method; 

(b) 

the  completion  of  the  technical  requirements  for  waste  characterisation 
contained in Annex II;  

(c) 

the interpretation of the definition contained in point 3 of Article 3;  

19 

OJ L 102, 11.4.2006, p. 1. 

EN 

28 

   EN 

                                                 
(d) 

(e) 

the  definition  of  the  criteria  for  the  classification  of  waste  facilities  in 
accordance with Annex III; 

the determination of any harmonised standards for sampling and analysis 
methods needed for the technical implementation of this Directive. 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 23(3). 

3. 

The Commission shall make the necessary amendments to the Annexes for the 
purpose of for adapting them 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 23(3)." 

(2) 

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." 

3. 

EUROSTAT 

3.1. 

Council Regulation (EC) No 2494/95 of 23 October 1995 concerning harmonized 
indices of consumer prices20 

As regards Regulation (EC) No 2494/95, power should in particular be conferred on 
the Commission to adopt rules to be followed to ensure the comparability of HICPs 
and to maintain and improve their reliability and relevance. Since those measures are 
of  general  scope  and  are  designed  to  amend  non-essential  elements  of  Regulation 
(EC) No 2494/95 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 (EC) No 2494/95 is amended as follows: 

In Article 3, the words "in Article 14" are replaced by the words "in Article 14 (2)".  

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

"The  Commission  (Eurostat),  shall  adopt  rules  to  be  followed  to  ensure  the 
comparability of HICPs. 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)." 

(1) 

(2) 

(3) 

In Article 5, paragraph 3 is replaced by the following: 

20 

OJ L 257, 27.10.1995, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) 

EN 

29 

   EN 

                                                 
"3.  The Commission shall adopt implementing measures for this Regulation which 
are necessary for ensuring the comparability of HICPs and for maintaining and 
improving their reliability and relevance, after consultation of the ECB. 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)." 

In Article 8(3) the words "in Article 14" are replaced by the words "in Article 14(2)".  

Article 9 is replaced by the following: 

"Article 9 

Production of results 

Member States shall process the data collected in order to produce the HICP, which 
shall be a Laspeyres-type index, covering the categories of the Coicop international 
classification (classification of individual consumption by purpose) (*), which shall 
be  adapted  by  the  Commission  to  establish  comparable  HICPs.  The  Commission 
shall  determine  the  methods,  procedures  and  formulae  to  ensure  that  the 
comparability  requirements  are  met.  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). 

-----------  

(*)  Published by the United Nations, series F No 2, revision 3, table 6.1, amended 

by the OECD (DES/NI/86.9), Paris 1986." 

In Article 11, the words "in Article 14" are replaced by the words "in Article 14(2)".  

Article 14 is replaced by the following: 

(4) 

(5) 

(6) 

(7) 

"Article 14 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
three months. 

EN 

30 

   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. 

______________________________________ 

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

(8) 

In Article 15, the second paragraph is replaced by the following: 

"In  those  reports,  the  Commission  shall  state  its  views  on  the  operation  of  the 
procedures  described  in  Article  14  and  shall  propose  any  amendments  it  considers 
appropriate." 

3.2. 

Council  Regulation  (EC)  No  577/98  of  9  March  1998  on  the  organisation  of  a 
labour force sample survey in the Community21 

As regards Regulation (EC) No 577/98, power should in particular be conferred on 
the Commission to adopt additional variables, to adapt the definitions, the edits to be 
used  and  the  codification  of  the  variables,  and  to  draw  up  the  list  of  structural 
variables, the minimum sample size and the survey frequency. Since those measures 
are of general scope and are designed to amend non-essential elements of Regulation 
(EC) No 577/98 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 577/98 is amended as follows: 

(1) 

In  the  third  indent  of  the  fifth  paragraph  of  Article  1,  the  words  "in  Article  8"  are 
replaced by the words "in Article 8(2)". 

(2) 

In Article 4, paragraphs 2, 3 and 4 are replaced by the following: 

"2.  A further set of variables, hereinafter referred to as an 'ad hoc module`, may be 

added to supplement the information described above in paragraph 1. 

Each  year  a  programme  of  ad  hoc  modules  covering  several  years  shall  be 
adopted by the Commission: 

- 

- 

this  programme  shall  specify  for  each  ad  hoc  module,  the  subject,  the 
reference  period,  the  sample  size  (equal  to  or  less  than  the  sample  size 
determined according to Article 3) and the deadline for the transmission 
of  the  results  (which  may  be  different  from  the  deadline  according  to 
Article 6), 

the  Member  States  and  regions  covered  and  the  detailed  list  of 
information  to  be  collected  in  an  ad  hoc  module  shall  be  drawn  up  at 
least twelve months before the beginning of the reference period for that 
module, 

21 

OJ  L  77,  14.3.1998,  p.  3.  Regulation  as  last  amended  by  Regulation  (EC)  No  1372/2007  of  the 
European Parliament and of the Council (OJ L 315, 3.12.2007, p. 6). 

EN 

31 

   EN 

                                                 
- 

the volume of an ad hoc module shall not exceed eleven variables. 

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 8(3). 

3. 

The  definitions,  the  edits  to  be  used,  the  codification  of  the  variables,  the 
adjustment  of  the  list  of  survey  variables  made  necessary  by  the  evolution  of 
techniques  and  concepts,  and  a  list  of  principles  for  the  formulation  of  the 
questions concerning the labour status shall be drawn up 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 8(3). 

identified  from  among 

'structural  variables',  may  be 

4.  On a proposal from the Commission, a list of variables, hereinafter referred to 
as 
the  survey 
characteristics  specified  in  paragraph  1  which  need  to  be  surveyed  only  as 
annual averages with reference to 52 weeks rather than as quarterly averages. 
This  list  of  structural  variables,  the  minimum  sample  size  and  the  survey 
frequency shall be drawn up 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  8(3).  Spain,  Finland  and  the  United  Kingdom  may  survey  the 
structural variables with reference to a single quarter during a transition period 
until the end of 2007." 

(3) 

Article 8 is replaced by the following: 

"Article 8 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
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 181, 28.6.1989, p. 47." 

EN 

32 

   EN 

3.3. 

Council  Regulation  (EC)  No  1165/98  of  19  May  1998  concerning  short-term 
statistics22 

As regards Regulation (EC) No 1165/98, powers should in particular be conferred on 
the Commission to approve and implement the European sample schemes, to adapt 
the  Annexes  and  to  determine  the  measures  for  implementing  this  Regulation, 
including  the  measures  to  accommodate  economic  and  technical  developments 
concerning  the  collection  and  statistical  processing  of  data  and  the  transmission  of 
the variables. Since those measures are of general scope and are designed to amend 
non-essential elements of Regulation (EC) No 1165/98, 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 (EC) No 1165/98 is amended as follows: 

(1) 

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

"(d)  participation in European sample schemes coordinated by Eurostat in order to 

produce European estimates. 

The  details  of  the  schemes  referred  to  in  the  first  subparagraph  shall  be  as 
specified in the Annexes. Measures for their approval and implementation shall 
be  adopted  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 18(3)." 

(2) 

In Article 16(1), the words "in Article 18" are replaced by the words "in Article 18 
(2)".  

(3) 

Articles 17 and 18 are replaced by the following: 

"Article 17 

Implementing measures 

The  Commission  shall  determine  the  measures  for  implementing  this  Regulation, 
including  the  measures  to  accommodate  economic  and  technical  developments 
concerning  the  collection  and  statistical  processing  of  data  and  the  transmission  of 
the  variables.  In  doing  so,  consideration  shall  be  given  to  the  principle  that  the 
benefits  of  the  measure  must  outweigh  its  cost,  and  to  the  principle  that  major 
additional resources are not involved either for Member States or for enterprises as 
compared with the original provisions of this Regulation. In particular the measures 
for implementing this Regulation shall include: 

(a) 

the use of particular units (Article 2); 

22 

OJ  L  162,  5.6.1998,  p.  1.  Regulation  as  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 

33 

   EN 

                                                 
(b) 

the updating of the list of variables (Article 3); 

(c) 

the  definitions  and  the  appropriate  forms  of  the  transmitted  variables  (Article 
3); 

(d) 

the frequency of compilation of the statistics (Article 5); 

(e) 

the levels of breakdown and aggregation to be applied to the variables (Article 
6); 

(f) 

the transmission deadlines (Article 8); 

(g) 

the criteria for the measurement of quality (Article 10); 

(h) 

the  transition  periods  and  derogations  granted  during  the  transition  period 
(Article 13); 

(i) 

the institution of pilot studies (Article 16); 

(j) 

the establishment of European sample schemes (Article 4); 

(k) 

the first base year to be applied for time series in NACE Rev. 2; 

(l) 

for time series prior to 2009, to be transmitted according to NACE Rev. 2, the 
level of detail, the form, the first reference period, and the reference period. 

The measures referred to in points (h) and (i) shall be adopted in accordance with the 
regulatory procedure referred to in Article 18(2). 

The  measures  referred  to  in  points  (a)  to  (g)  and  (j)  to  (l),  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 18(3). 

Article 18 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
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. 

EN 

34 

   EN 

____________________________________ 

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

(4)  Annex A ('Industry') is amended as follows: 

(a)  Point (a) ('Scope') is replaced by the following: 

"(a)  Scope 

This Annex applies to all activities listed in Sections B to E of NACE Rev. 2, 
or as the case may be, to all products listed in Sections B to E of the CPA. The 
information is not required for 37, 38.1, 38.2 and 39 of NACE Rev. 2. The list 
of activities may be revised 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 18(3)." 

(b) 

In point (b) ('Observation unit'), paragraph 3 is replaced by the following: 

"3.  The use of other observation units can be decided 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 18(3)." 

(c)  Point (c) ('List of variables'), is amended as follows: 

(i) 

In paragraph 2, the last sentence is replaced by the following: 

"The  Commission  shall  determine  the  conditions  for  assuring  the  necessary  data 
quality.  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 18(3)." 

(ii)  Paragraphs 3 and 4 are replaced by the following: 

"3.  Starting from the beginning of the first reference period the information 
on  new  orders  (Nos  130,  131,  132)  may  be  approximated  by  an 
alternative  leading  indicator,  which  may  be  calculated  from  business 
opinion survey data. This approximation is permitted for a period of five 
years  from  the  date  of  entry  into  force  of  the  Regulation.  This  period 
shall be extended by up to five more years unless decided differently 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 18(3). 

4. 

Starting from the beginning of the first reference period the information 
on  persons  employed  (No  210)  may  be  approximated  by  the  number  of 
employees (No 211). This approximation is permitted for a period of five 
years  from  the  date  of  entry  into  force  of  the  Regulation.  This  period 
shall be extended by up to five more years unless decided differently by 

EN 

35 

   EN 

 
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 18(3)." 

(iii)  In paragraph 8, the last sentence is replaced by the following: 

"The list of activities may be revised 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 18(3)." 

(iv) 

in paragraph 10, the last sentence is replaced by the following: 

"The list of activities may be revised 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 18(3)." 

(d) 

In point (d) ('Form'), paragraph 2 is replaced by the following: 

"2. 

In  addition,  the  production  variable  (No  110)  and  the  hours-worked  variable 
(No 220) are to be transmitted in working-day adjusted form. 

Wherever other variables show working-day effects, Member States may also 
transmit those variables in working-day adjusted form. The list of variables to 
be  transmitted  in  working-day  adjusted  form  may  be  amended  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 18(3)." 

(e) 

In point (f) ('Level of detail'), paragraphs 8 and 9 are replaced by the following: 

"8.  For  the  import  price  variable  (No  340),  the  Commission  may  determine  the 
terms  for  applying  a  European  sample  scheme  as  defined  in  point  (d)  of  the 
first  subparagraph  of  Article  4(2).  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 
18(3). 

9. 

The variables on the non-domestic markets (Nos 122, 132 and 312) are to be 
transmitted according to the distinction into euro-zone and non-euro-zone. The 
distinction  is  to  be  applied  to  the  total  industry  defined  as  NACE  Rev.  2 
Sections B to E, the MIGs, the Section (1 letter) and Division 2-digit level of 
NACE Rev. 2. The information on NACE Rev. 2 D and E is not required for 
variable  122.  In  addition,  the  import  price  variable  (No  340)  is  to  be 
transmitted according to the distinction into euro-zone and non-euro-zone. The 
distinction is to be applied to the total industry defined as CPA Sections B to E, 
the  MIGs,  the  Section  (1  letter)  and  Division  2-digit  level  of  CPA.  For  the 
distinction  into  the  euro-zone  and  non-euro-zone,  the  Commission  may 
determine the terms for applying European sample schemes as defined in point 
(d)  of  the  first  subparagraph  of  Article  4(2).  Those  measures,  designed  to 

EN 

36 

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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  18(3).  The  European  sample  scheme  may  limit  the  scope  of  the 
import price variable to the import of products from non-euro-zone countries. 
The  distinction  into  the  euro-zone  and  non-euro-zone  for  the  variables  122, 
132, 312 and 340 does not need to be transmitted by those Member States that 
have not adopted the euro as their currency." 

(f) 

In  point  (j)  ('Transition  period'),  all  references  to  Article  18  are  replaced  by 
references to Article 18 (2).  

(5) 

Annex B ('Construction') is amended as follows: 

(a) 

In point (b) ('Observation unit'), paragraph 4 is replaced by the following: 

"4.  The use of other observation units can be decided 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 18(3)." 

(b)  Point (c) ('List of variables'), is amended as follows: 

(i) 

Paragraph 3 is replaced by the following: 

"3.  Starting from the beginning of the first reference period the information 
on  persons  employed  (No  210)  may  be  approximated  by  the  number  of 
employees (No 211). This approximation is permitted for a period of five 
years from the date of entry into force of the Regulation. The procedure 
shall be extended for up to five more years unless decided differently 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 18(3)." 

(ii) 

In paragraph 6, the last subparagraph is replaced by the following:  

"The Commission shall decide no later than 11 August 2008 whether to invoke 
Article  17(b)  to  replace  the  construction  costs  variable  with  the  output  price 
variable with effect from base year 2010. 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 
18(3)." 

(c) 

In point (d) ('Form'), paragraph 2 is replaced by the following: 

"2. 

In  addition,  the  variables  on  production  (Nos  110,  115,  116)  and  the  hours 
worked variable (No 220) are to be transmitted in working-day adjusted form. 
Wherever other variables show working-day effects, Member States may also 
transmit those variables in working-day adjusted form. The list of variables to 
be  transmitted  in  working-day  adjusted  form  may  be  amended  by  the 
Commission.  Those  measures,  designed  to  amend  non-essential  elements  of 

EN 

37 

   EN 

this  Regulation  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 18(3)." 

(d) 

In  point  (j)  ('Transition  period'),  all  references  to  Article  18  are  replaced  by 
references to Article 18 (2). 

(6)  Annex C ('Retail trade and repair) is amended as follows: 

(a) 

In point (b) ('Observation unit'), paragraph 2 is replaced by the following: 

"2.  The use of other observation units can be decided 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 18(3)." 

(b)  Point (c) ('List of variables'), is amended as follows: 

(i) 

Paragraph 3 is replaced by the following: 

"3.  Starting from the beginning of the first reference period the information 
on  persons  employed  (No  210)  may  be  approximated  by  the  number  of 
employees (No 211). This approximation is permitted for a period of five 
years  from  the  date  of  entry  into  force  of  the  Regulation.  This  period 
shall be extended for up to five more years unless decided differently 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 18(3)." 

(ii) 

In paragraph 4, the last subparagraph is replaced by the following  

"The Commission shall decide no later than 11 August 2008 whether to invoke 
Article  17(b),  so  as  to  include  the  variable  hours  worked  (No  220)  and  the 
variable gross wages and salaries (No 230) with effect from the base year 2010. 
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 18(3)." 

(c) 

In point (d) ('Form'), paragraph 2 is replaced by the following: 

"2.  The turnover variable (No 120) and the volume of sales variable (No 123) are 
also  to  be  transmitted  in  a  working-day  adjusted  form.  Wherever  other 
variables  show  working-day  effects,  Member  States  may  also  transmit  those 
variables in working-day adjusted form. The list of variables to be transmitted 
in  working-day  adjusted  form  may  be  amended  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 18(3)." 

(d) 

In point (g) ('Deadlines for data transmission'), paragraph 2 is replaced by the 
following: 

EN 

38 

   EN 

 
"2.  The  variables  shall  be  transmitted  for  turnover  (No  120)  and  the  deflator  of 
sales/volume  of  sales  (No  330/123)  within  one  month  for  the  level  of  detail 
specified in paragraph 3 under heading (f) of this Annex. Member States may 
choose  to  participate  for  the  turnover  and  deflator  of  sales/volume  of  sales 
variables No 120 and 330/123 with contributions according to the allocation of 
a European sample scheme as defined in point (d) of the first subparagraph of 
Article  4(2).  The  terms  of  the  allocation  are  to  be  determined  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 18(3)." 

(e) 

In  point  (j)  ('Transition  period'),  all  references  to  Article  18  are  replaced  by 
references to Article 18 (2). 

(7) 

Annex D ('Other services') is amended as follows: 

(a) 

In point (b) ('Observation unit'), paragraph 2 is replaced by the following: 

"2.  The use of other observation units can be decided 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 18(3)." 

(b)  Point (c) ('List of variables'), is amended as follows: 

(i) 

Paragraph 2 is replaced by the following: 

"2.  Starting from the beginning of the first reference period the information 
on  persons  employed  (No  210)  may  be  approximated  by  the  number  of 
employees (No 211). This approximation is permitted for a period of five 
years from the date of entry into force of the Regulation. The period shall 
be  extended  by  up  to  five  more  years  unless  decided  differently  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 18(3)." 

(ii) 

In paragraph 4, the last subparagraph is replaced by the following : 

"The Commission shall decide no later than 11 August 2008 whether to invoke 
Article  17(b)  so  as  to  include  the  variable  hours  worked  (No  220)  and  the 
variable  gross  wages  and  salaries  (No  230)  with  effect  from  base  year  2010. 
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 18(3)." 

(c) 

In point (d) ('Form'), paragraph 2 is replaced by the following: 

"2.  The  turnover  variable  (No  120)  is  also  to  be  transmitted  in  working-day 
adjusted  form.  Wherever  other  variables  show  working-day  effects,  Member 
States may also transmit those variables in working-day adjusted form. The list 
of variables to be transmitted in working-day adjusted form may be amended 
by  the  Commission.  Those  measures,  designed  to  amend  non-essential 

EN 

39 

   EN 

elements  of  this  Regulation  by  supplementing  it,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
18(3)." 

(d) 

In point (e) ('Reference period'), last sentence is replaced by the following: 

"The  Commission  shall  decide  no  later  than  11  August  2008  whether  to  invoke 
Article  17(d)  in  connection  with  a  revision  of  the  frequency  of  compilation  of  the 
turnover variable. 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 18(3)." 

(e) 

In point (f) ('Level of detail'), paragraph 6 is replaced by the following: 

"6.  The Commission may amend the list of activities and groupings no later than 
11 August 2008. 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 18(3)." 

(f) 

In  points  (i)  ('First  reference  period')  and  (j)  ('Transition  period'),  all 
references to Article 18 are replaced by references to Article 18 (2).  

3.4. 

Council  Regulation  (EC)  No  530/1999  of  9  March  1999  concerning  structural 
statistics on earnings and on labour costs23 

As regards Regulation (EC) No 530/1999, power should in particular be conferred on 
the  Commission  to  adapt  the  definition  and  breakdown  of  the  information  to  be 
provided, and to lay down the quality evaluation criteria. Since those measures are of 
general scope and are designed to amend non-essential elements of Regulation (EC) 
No  530/1999  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 530/1999 is amended as follows: 

(1) 

Articles 11 and 12 are replaced by the following: 

"Article 11 

Implementation measures 

The  measures  necessary  for  the  implementation  of  this  Regulation,  including 
measures to take account of economic and technical changes, shall be adopted by the 
Commission for each reference period at least nine months before the beginning of 
the reference period:  

(i) 

the definition and breakdown of the information to be provided (Article 6), 

23 

OJ  L  63,  12.3.1999,  p.  6.  Regulation  as  last  amended  by  Regulation  (EC)  No  1893/2006  of  the 
European Parliament and of the Council (OJ L 393, 31.12.2006, p. 1). 

EN 

40 

   EN 

                                                 
(ii) 

the appropriate technical format for the transmission of the results (Article 9), 

(iii)  quality evaluation criteria (Article 10), 

(iv)  derogations,  in  duly  justified  cases,  for  periods  2004  and  2006,  respectively 

(Article 13(2)). 

The measures referred to in points (ii) and (iv) shall be adopted in accordance with 
the regulatory procedure referred to in Article 12(2). 

The  measures  referred  to  in  points  (i)  and  (iii),  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). 

Article 12 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
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 181, 28.6.1989, p. 47." 

3.5. 

Regulation (EC) No 450/2003 of the European Parliament and of the Council of 
27 February 2003 concerning the labour cost index24 

As regards Regulation (EC) No 450/2003, power should in particular be conferred on 
the  Commission  to  adapt  the  definitions  and  amend  the  technical  specifications, 
include  new  sections  in  the  survey,  adapt  the  breakdown  of  indices  by  economic 
activities,  define  the  quality  criteria,  establish  feasibility  studies  and  take  decisions 
pursuant to their results, and determine the methodology to be used for chaining the 
index.  Since  those  measures  are  of  general  scope  and  are  designed  to  amend  non-
essential  elements  of  Regulation  (EC)  No  450/2003  and  to  supplement  it  by  the 
addition of new non-essential elements, they must be adopted in accordance with the 

24 

OJ  L  69,  13.3.2003,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  1893/2006  of  the 
European Parliament and of the Council (OJ L 393 31.12.2006, p. 1). 

EN 

41 

   EN 

                                                 
regulatory  procedure  with  scrutiny  provided  for  in  Article  5a  of  Decision 
1999/468/EC. 

Accordingly, Regulation (EC) No 450/2003 is amended as follows : 

(1) 

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

"4.  The Commission may take measures to redefine the technical specification of 
the  index  and  revise  the  weighting  structure.  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)." 

(2) 

In Article 3, paragraph 2 is replaced by the following: 

"2.  The inclusion of economic activities defined by NACE Rev.2 sections O to S 
in the scope of this Regulation shall be determined by the Commission, taking 
into  account  the  feasibility  studies  defined  in  Article  10.  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)." 

(3) 

Article 4 is replaced by the following: 

"Article 4 

Breakdown of variables 

1. 

The data shall be broken down by economic activities defined by NACE Rev. 2 
sections  and  by  further  disaggregations,  defined  by  the  Commission,  not 
beyond  the  level  of  NACE  Rev.  2  divisions  (2  digit  level)  or  groupings  of 
divisions,  taking  account  of  contributions  to  total  employment  and  to  labour 
costs  at  Community  and  national  levels.  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). 

Labour  cost  indices  shall  be  provided  separately  for  the  three  labour  cost 
categories identified below: 

(a) 

total labour costs; 

(b)  wages  and  salaries,  defined  by  reference  to  item  D.11  in  Annex  II  to 

Regulation (EC) No 1726/1999; 

(c) 

employers'  social  contributions  plus  taxes  paid  by  the  employer  less 
subsidies received by the employer, as defined by the sum of items D.12 
and D.4 less D.5 in Annex II to Regulation (EC) No 1726/1999. 

2.  An index estimating total labour costs, excluding bonuses, where bonuses are 
defined  by  D.11112  in  Annex  II  to  Regulation  (EC)  No  1726/1999,  shall  be 

EN 

42 

   EN 

provided, broken down by economic activities defined by the Commission and 
shall  be  based  on  the  NACE  Rev.  2  classification,  taking  into  account  the 
feasibility  studies  defined  in  Article  10.  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)."  

(4) 

Article 8 is replaced by the following: 

"Article 8 

Quality 

1. 

2. 

The current data and back data transmitted shall satisfy separate quality criteria 
to  be  defined  by  the  Commission.  That  measure,  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). 

The  Member  States  shall  provide  annual  quality  reports  to  the  Commission, 
beginning  in  2003.  The  content  of  the  reports  shall  be  defined  by  the 
Commission. That measure, 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)." 

(5) 

Articles 11 and 12 are replaced by the following:  

"Article 11 

Implementing measures 

The measures for implementing this Regulation, including measures to take account 
of economic and technical changes, shall be laid down by the Commission: 

(a) 

definition,  in  accordance  with  Article  4(1),  of  the  disaggregations  to  be 
included in the fixed structure; 

(b) 

technical specification of the index (Article 2); 

(c) 

inclusion of NACE Rev.2 sections O to S (Article 3); 

(d)  breakdown of indices by economic activities (Article 4); 

(e) 

(f) 

format for transmission of results and the adjustment procedures to be applied 
(Article 6); 

separate  quality  criteria  for  current  and  back  data  transmitted  and  contents  of 
quality reports (Article 8); 

EN 

43 

   EN 

(g) 

transition period (Article 9); 

(h) 

the  establishment  of  feasibility  studies  and  decisions  pursuant  to  their  results 
(Article 10); and 

(i) 

the methodology to be used for chaining the index (Annex). 

The  measures  referred  to  in  points  (e),  (g)  and  (h)  shall  be  adopted  in  accordance 
with the regulatory procedure referred to in Article 12(2). 

The measures referred to in points (a), (b), (c), (d), (f) and (i), 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). 

Article 12 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
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 181, 28.6.1989, p. 47." 

3.6. 

Regulation EC) No 1552/2005 of the European Parliament and of the Council of 
7 September 2005 on statistics relating to vocational training in enterprises25 

As regards Regulation (EC) No 1552/2005, power should in particular be conferred 
on  the  Commission  to  adapt  the  definitions  and  sampling  methods,  to  define  the 
specific  data  to  be  collected  and  to  determine  the  quality  requirements  for  the  data 
and  the  transmission  arrangements.  Since  those  measures  are  of  general  scope  and 
are designed to amend non-essential elements of Regulation (EC) No 1552/2005 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. 

25 

OJ L 255, 30.9.2005, p.1. Regulation last amended by Regulation (EC) No 1893/2006 of the European 
Parliament and of the Council (OJ L 393 31.12.2006, p. 1).  

EN 

44 

   EN 

                                                 
Accordingly, Regulation (EC) No 1552/2005 is amended as follows: 

(1) 

In Article 5, paragraph 2 is replaced by the following: 

"2.  Having  regard  to  the  specific  national  size  distribution  of  enterprises  and  the 
evolution  of  policy  needs,  Member  States  may  extend  the  definition  of  the 
statistical unit in their country. The Commission may also decide to extend this 
definition, if such extension would enhance substantially the representativeness 
and  the  quality  of  the  result  of  the  survey  in  the  Member  States  concerned. 
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) 

In Article 7, paragraph 3 is replaced by the following: 

"3.  Sampling  and  precision  requirements,  the  sample  sizes  needed  to  meet  these 
requirements,  and  the  detailed  specifications  of  the  NACE  Rev.  2  and  size 
categories  into  which  the  results  can  be  broken  down  shall  be  determined  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)." 

(3) 

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

"2.  The  specific  data  to  be  collected  with  respect  to  training  and  non-training 
enterprises and to the different forms of vocational training shall be determined 
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)." 

(4) 

In Article 9, paragraph 4 is replaced by the following: 

"4.  The  quality  requirements  for  the  data  to  be  collected  and  transmitted  for 
Community statistics on vocational training in enterprises, the structure of the 
quality  reports  referred  to  in  paragraph  2  and  any  measures  necessary  for 
assessing  or  improving  the  quality  of  the  data  shall  be  determined  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)." 

(5) 

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

"2.  The Commission shall determine the first reference year for which the data are 
to be collected. That 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 14(3)." 

(6) 

Articles 13 and 14 are replaced by the following: 

EN 

45 

   EN 

"Article 13 

Implementing measures 

The  implementing  measures  concerning  the  appropriate  technical  format  and 
interchange  standard  of  the  electronically  transmitted  data  shall  be  adopted  in 
accordance with the procedure referred to in Article 14(2). 

The  measures  necessary  for  the  implementation  of  this  Regulation,  including 
measures  to  take  account  of  economic  and  technical  developments  concerning  the 
collection,  transmission  and  processing  of  the  data,  shall  be  adopted  in  accordance 
with the procedure referred to in Article 14(3). 

Article 14 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
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 181, 28.6.1989, p. 47." 

4. 

INTERNAL MARKET 

4.1. 

Regulation (EC) No 2195/2002 of the European Parliament and of the Council 
of 5 November 2002 on the Common Procurement Vocabulary (CPV)26  

As regards Regulation (EC) No 2195/2002, power should in particular be conferred 
on  the  Commission  to  update  the  structure  and  codes  of  the  CPV  and  to  make 
technical  adjustments  to  any  of  the  annexes  to  this  Regulation  in  order  to  provide 
users  with  a  tool  adapted  to  their  needs  and  to  developments  in  the  market.  Since 
those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential 
elements  of  Regulation  (EC)  No  2195/2002,  they  must  be  adopted  in  accordance 

26 

OJ L 340, 16.12.2002, p.1. Regulation as last amended by Regulation (EC) No 2151/2003 (OJ L 329, 
17.12.2003, p.1)  

EN 

46 

   EN 

                                                 
with the regulatory procedure with scrutiny provided for in Article 5(a) 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 adoption of amendments of a purely technical nature. 

Accordingly, Regulation (EC) No 2195/2002 is amended as follows: 

(1) 

Articles 2 and 3 are replaced by the following: 

"Article 2 

The  Commission  shall  adopt  the  measures  necessary  for  the  revision  of  the  CPV. 
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 3(2). On imperative grounds of urgency, the Commission may use the urgent 
procedure referred to in Article 3(3). 

Article 3 

1. 

The  Commission  shall  be  assisted  by  the  Committee  established  by  Council 
Decision 71/306/EEC (*), hereinafter referred to as "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. 

3.  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 185, 16.8.1971, p.15. Decision as amended by Decision 77/63/EEC (OJ L 
13, 15.1.1977, p.15)."  

4.2. 

Directive  2004/17/EC  of  the  European  Parliament  and  of  the  Council  of  31 
March  2004  coordinating  the  procurement  procedures  of  entities  operating  in 
the water, energy, transport and postal services sectors27 

As  regards  Directive  2004/17/EC,  powers  should  in  particular  be  conferred  on  the 
Commission to make technical adjustments to certain passages of the instrument and 
its annexes, in line with technical progress or developments in Member States, and to 
revise the thresholds for application of the arrangements. Since those measures are of 
general  scope  and  are  designed  to  amend  non-essential  elements  of  Directive 

27 

OJ L 134, 30.4.2004, p 1. 

EN 

47 

   EN 

                                                 
2004/17/EC, they must be adopted in accordance with the regulatory procedure with 
scrutiny provided for in Article 5(a) of Decision 1999/468/EC. 

On  the  grounds  of  efficiency  and  because  of  the  time  limits  imposed  by  the 
procedures for calculation and publication laid down, the normal time limits for the 
regulatory  procedure  with  scrutiny  should  be  curtailed  for  the  revision  of  certain 
thresholds. 

When  on  imperative  grounds  of  urgency,  the  normal  time  limits  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 adoption of amendments of a purely technical nature. 

Accordingly, Directive 2004/17/EC is amended as follows: 

(1) 

Article 68 is replaced by the following: 

" Article 68 

Committee 

1. 

The  Commission  shall  be  assisted  by  the  Committee  instituted  by  Council 
Decision 71/306/EEC(*) (hereinafter referred to as "the Committee").  

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, 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) 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 set at two weeks.  

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. 

_________________________________________ 

(*) OJ L 185, 16.8.1971, p.15. Decision as amended by Decision 77/63/EEC (OJ L 
13, 15.1.1977, p.15)."  

(2) 

Article 69 is amended as follows : 

a) 

In paragraph 1, the first subparagraph is replaced by the following: 

EN 

48 

   EN 

"The  Commission  shall  verify  the  thresholds  established  in  Article  16  every 
two years from 30 April 2004, and shall, if necessary, with regard to the second 
subparagraph,  revise  them.  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 68(4). On imperative grounds of 
urgency, the Commission may use the urgent procedure referred to in Article 
68(5)." 

b) 

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

"At  the  same  time  as  performing  the  revision  under  paragraph  1,  the 
Commission shall align the thresholds laid down in Article 61 (design contests) 
with  the  revised  threshold  applicable  to  service  contracts.  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 
68(4). On imperative grounds of urgency, the Commission may use the urgent 
procedure referred to in Article 68(5)." 

(3) 

Article 70 is replaced by the following: 

"Article 70 

Amendments 

1. 

The Commission may amend, in accordance with the procedure provided for in 
Article 68(2): 

(a) 

(b) 

(c) 

the procedure for sending and publishing data referred to in Annex XX, 
on grounds of technical progress or for administrative reasons; 

the  procedures  for  the  drawing-up,  transmission,  receipt,  translation, 
collection and distribution of the notices referred to in Articles 41, 42, 43 
and 63; 

in the interests of administrative simplification as provided for in Article 
67(3),  the  procedures  for  the  use,  drawing-up,  transmission,  receipt, 
translation, collection and distribution of the statistical reports referred to 
in Article 67(1) and (2); 

2. 

The Commission may amend the following:  

(a) 

(b) 

(c) 

the  list  of  contracting  entities  in  Annexes  I  to  X  so  that  they  fulfil  the 
criteria set out in Articles 2 to 7; 

the procedures for specific references to particular positions in the CPV 
nomenclature in the notices; 

the reference numbers in the nomenclature set out in Annex XVII, in so 
far  as  this  does  not  change  the  material  scope  of  the  Directive,  and  the 

EN 

49 

   EN 

procedures  for  reference  in  the  notices  to  particular  positions  in  this 
nomenclature within the categories of services listed in the Annex; 

(d) 

the reference numbers in the nomenclature set out in Annex XII, insofar 
as  this  does  not  change  the  material  scope  of  the  Directive,  and  the 
procedures  for  reference  to  particular  positions  of  this  nomenclature  in 
the notices; 

(e)  Annex XI; 

(f) 

(g) 

the  technical  details  and  characteristics  of  the  devices  for  electronic 
receipt referred to in points (a), (f) and (g) of Annex XXIV; 

the  technical  procedures  for  the  calculation  methods  set  out  in  Article 
69(1) and (2), second subparagraph. 

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  68(3).  On  imperative  grounds  of  urgency,  the 
Commission may use the urgent procedure referred to in Article 68(5)." 

4.3. 

Directive  2004/18/EC  of  the  European  Parliament  and  of  the  Council  of  31 
March  2004  on  the  coordination  of  procedures  for  the  award  of  public  works 
contracts, public supply contracts and public service contracts28 

As  regards  Directive  2004/18/EC,  power  should  in  particular  be  conferred  on  the 
Commission to make technical adjustments to certain passages of the instrument and 
its annexes, in line with technical progress or developments in Member States, and to 
revise the thresholds for application of the arrangements. Since those measures are of 
general  scope  and  are  designed  to  amend  non-essential  elements  of  Directive 
2004/18/EC, they must be adopted in accordance with the regulatory procedure with 
scrutiny provided for in Article 5(a) of Decision 1999/468/EC. 

On  the  grounds  of  efficiency  and  because  of  the  time  limits  imposed  by  the 
procedures for calculation and publication laid down, the normal time limits for the 
regulatory  procedure  with  scrutiny  should  be  curtailed  for  the  revision  of  certain 
thresholds. 

When  on  imperative  grounds  of  urgency,  the  normal  time  limits  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 adoption of amendments of a purely technical nature. 

Accordingly, Directive 2004/18/EC is amended as follows: 

(1) 

Article 77 is replaced by the following: 

28 

OJ L 134, 30.4.2004, p 114. 

EN 

50 

   EN 

                                                 
"Article 77 

Committee 

1. 

The  Commission  shall  be  assisted  by  the  Committee  instituted  by  Council 
Decision 71/306/EEC(*) (hereinafter referred to as "the Committee").  

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, 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) 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 set at two weeks.  

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. 

_________________________________________ 

(*) OJ L 185, 16.8.1971, p.15. Decision as amended by Decision 77/63/EEC (OJ L 
13, 15.1.1977, p.15)."  

(2) 

(a) 

Article 78 is amended as follows: 

In paragraph 1, the first subparagraph is replaced by the following: 

"The Commission shall verify the thresholds established in Article 7 every two years 
from 30 April 2004 and shall, if necessary, revise them. 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  77(4).  On  imperative 
grounds  of  urgency,  the  Commission  may  use  the  urgent  procedure  referred  to  in 
Article 77(5)." 

(b) 

Paragraph 2 is replaced by the following: 

"2.  At  the  same  time  as  the  revision  under  paragraph  1,  the  Commission  shall 

align: 

(a) 

(b) 

the thresholds established in (a) of the first subparagraph of Article 8, in 
Article  56  and  in  the  first  subparagraph  of  Article  63(1)  on  the  revised 
threshold applying to public works contracts; 

the  thresholds  established  in  (b)  of  the  first  subparagraph  of  Article  8, 
and in Article 67(1)(a) on the revised threshold applying to public service 
contracts  concluded  by  the  contracting  authorities  referred  to  in  Annex 
IV; 

EN 

51 

   EN 

 
(c) 

the  threshold  established  in  Article  67(1)(b)  and  (c)  on  the  revised 
threshold applying to public service contracts awarded by the contracting 
authorities not included 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  77(4).  On  imperative  grounds  of  urgency,  the  Commission  may  use  the 
urgent procedure referred to in Article 77(5)."  

(3) 

Article 79 is replaced by the following: 

"Article 79 

Amendments 

1. 

The Commission may amend, in accordance with the procedure provided for in 
Article 77(2): 

(a) 

the  procedures  for  the  drawing-up,  transmission,  receipt,  translation, 
collection and distribution of the notices referred to in Articles 35, 58, 64 
and 69 and the statistical reports provided for in the fourth subparagraph 
of Article 35(4), and in Articles 75 and 76; 

(b) 

the procedure for sending and publishing data referred to in Annex VIII, 
on grounds of technical progress or for administrative reasons. 

2. 

The Commission may amend the following:  

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the technical procedures for the calculation methods set out in the second 
subparagraph of Article 78(1) and in Article 78(3); 

the  procedures  for  specific  reference  to  specific  positions  in  the  CPV 
nomenclature in the notices; 

the  lists  of  bodies  and  categories  of  bodies  governed  by  public  law  in 
Annex  III,  when,  on  the  basis  of  the  notifications  from  the  Member 
States, these prove necessary; 

the  lists  of  central  government  authorities  in  Annex  IV,  following  the 
adaptations necessary to give effect to the Agreement; 

the reference numbers in the nomenclature set out in Annex I, insofar as 
this  does  not  change  the  material  scope  of  this  Directive,  and  the 
procedures  for  reference  to  particular  positions  of  this  nomenclature  in 
the notices; 

the reference numbers in the nomenclature set out in Annex II, insofar as 
this  does  not  change  the  material  scope  of  this  Directive,  and  the 
procedures  for  reference  in  the  notices  to  particular  positions  in  this 
nomenclature within the categories of services listed in the Annex; 

EN 

52 

   EN 

(g) 

the  technical  details  and  characteristics  of  the  devices  for  electronic 
receipt referred to in points (a), (f) and (g) of Annex X. 

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  77(4).  On  imperative  grounds  of  urgency,  the 
Commission may use the urgent procedure referred to in Article 77(5)." 

5. 

HEALTH AND CONSUMER PROTECTION 

5.1. 

Council  Regulation  (EEC)  No  315/93  of  8  February  1993  laying  down 
Community procedures for contaminants in food29 

As  regards  Regulation  (EEC)  No  315/93,  power  should  in  particular  be  conferred  on  the 
Commission  to  establish  maximum  tolerances  for  specific  contaminants.  Since  those 
measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of  that 
Regulation  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. 

Any  delay  in  the  establishment  of  maximum  tolerances  for  specific  contaminants  could 
represent  a  threat  to  human  or  animal  health.  When,  on  imperative  grounds  of  urgency,  the 
normal  time  limits  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 adoption of these tolerances. 

Accordingly Regulation (EEC) No 315/93 is amended as follows:  

(1) 

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

"In order to protect public health and pursuant to paragraph 1, where necessary, the 
Commission may establish the maximum tolerances for specific contaminants. 
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  8(3).  On  imperative  grounds  of 
urgency, the Commission may use the urgent procedure referred to in Article 
8(4).  

(2) 

(3) 

In Article 4(2), the words "Article 8" are replaced by the words "Article 8(2)". 

In the fourth subparagraph of Article 5(3), the words "Article 8" are replaced by the 
words "Article 8(2)". 

(4) 

Article 8 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."; 

29 

OJ L 37, 13.2.1993, p. 1. 

EN 

53 

   EN 

                                                 
(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." 

5.2. 

Council  Directive  93/74/EEC  of  13  September  1993  on  feedingstuffs  intended 
for particular nutritional purposes30 

As regards Directive 93/74/EEC, powers should in particular be conferred on the Commission 
to adopt general provisions regarding the application of the indications contained in the list of 
intended  uses  and  amendments,  in  line  with  developments  in  scientific  and  technical 
knowledge, to the list of intended uses and the general provisions regarding the application of 
the  indications  contained  in  the  list  of  intended  uses.  Since  those  measures  are  of  general 
scope  and  are  designed  to  amend  non-essential  elements  of  Directive  93/74/EEC  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. 

Feedingstuffs intended for particular nutritional purposes are playing an increasing role in the 
diet of pet animals and are also used in the rearing of productive livestock. The composition 
and  preparation  of  such  feedingstuffs  must  be  specially  designed  to  meet  the  particular 
nutritional needs of categories of pets or productive livestock whose process of assimilation, 
absorption or metabolism could briefly be impaired or is temporarily or irreversibly impaired. 
Users  of  such  feedingstuffs  therefore  need  to  be  provided  immediately  with  accurate  and 
meaningful information so that they can make appropriate choices. Consequently and on the 
grounds  of  efficiency,  the  normal  time  limits  for  the  regulatory  procedure  with  scrutiny 
should  be  curtailed  for  the  adoption  of  general  provisions  regarding  the  application  of  the 
indications contained in the list of intended uses and for the adoption of amendments, in line 
with developments in scientific and technical knowledge, to the list of intended uses and the 
general provisions regarding the application of the indications contained in the list of intended 
uses. 

Accordingly, Directive 93/74/EEC is amended as follows : 

(1) 

Article 6 is replaced by the following:  

The Commission shall adopt: 

"Article 6 

(a) 

a list of intended uses as set out in the Annex  not later  than 30  June 1994 in 
accordance  with  the  procedure  referred  to  in  Article  9(2).  That  list  shall 
contain: 

– 

the indications referred to in Article 5(1) (b), (c), (d) and (e), and, 

30 

OJ L 237, 22.9.1993, p. 23. 

EN 

54 

   EN 

                                                 
– 

where appropriate, the indications referred to in Article 5(2) and Article 
5(4), second subparagraph; 

(b)  general provisions regarding the application of the indications referred to in (a), 

including applicable tolerances; 

(c) 

amendments  to  the  measures  adopted  in  accordance  with  (a)  and  (b)  in  line 
with developments in scientific and technical knowledge. 

The measures provided for in (b) and (c), 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). 

In Article 8(2), the words "Article 9" are replaced by the words "Article 9(2)". 

In Article 9, paragraph 3 is replaced by the following: 

"3.  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  set  at  two  months,  one  month  and  two  months 
respectively." 

(2) 

(3) 

5.3. 

Council  Directive  96/23/EC  of  29  April  1996  on  measures  to  monitor  certain 
substances  and  residues  thereof  in  live  animals  and  products  and  repealing 
Directives  85/358/EEC  and  86/469/EEC  and  Decisions  89/187/EEC  and 
91/664/EEC31 

As regards Directive 96/23/EC, power should in particular be conferred on the Commission to 
adopt  amendments  to  the  Annexes.  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  must  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

Accordingly, Directive 96/23/EC is amended as follows: 

(1) 

Article 6 is replaced by the following: 

"Article 6 

1. 

The  plan  must  conform  to  the  sampling  levels  and  frequencies  laid  down  in 
Annex  IV.  However,  at  the  request  of  a  Member  State  the  Commission  may 
adjust the minimum control requirements laid down in Annex IV provided that 
it is clearly established that such adjustments increase the overall effectiveness 
of the plan in respect of the Member State concerned and in no way reduce its 
ability  to  identify  residues  of,  or  cases  of  illegal  treatment  with,  substances 

31 

OJ  L  125,  23.5.1996,  p.  10.  Directive  as  last  amended  by  Directive  2006/104/EC  (OJ  L  363, 
20.12.2006, p. 352). 

EN 

55 

   EN 

 
                                                 
listed 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 33(4). 

2. 

Re-examination of the groups of residues to be checked for in accordance with 
Annex  II  and  determination  of  the  sampling  levels  and  frequencies  covering 
the animals and products referred to in Article 3 and not already laid down in 
Annex  IV  shall  be  carried  out  by  the  Commission  and  on  the  first  occasion 
within a maximum of 18 months of the adoption of this Directive. In doing so, 
account  shall  be  taken  of  experience  gained  under  existing  national  measures 
and  information  forwarded  to  the  Commission  under  existing  Community 
requirements  making  such  specific  product  groups  subject  to  monitoring  for 
residues.  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 33(4)."  

(2) 

Article 8 is amended as follows: 

(a) 

In  paragraph  1,  the  second  and  third  subparagraphs  are  replaced  by  the 
following: 

"Once  the  Commission  has  established  their  conformity,  it  shall  submit  the 
plans for approval in accordance with the procedure referred to in Article 
33(3). 

In order to take account of changes in the situation in a given Member State or 
in a region thereof, of the results of national surveys or of investigations 
carried out in the framework of Articles 16 and 17, the Commission may, 
at  the  request  of  the  Member  State  concerned  or  on  its  own  initiative, 
decide, in accordance with the procedure referred to in Article 33(2), to 
approve  an  amendment  or  addition  to  a  plan  previously  approved 
pursuant to paragraph 2." 

(b) 

In paragraph 2, the fifth subparagraph is replaced by the following: 

"Where  there  are  comments  from  Member  States  or  where  the  Commission 
deems the update not to be in conformity or insufficient, the Commission 
shall  submit  the  updated  plans  to  the  Standing  Veterinary  Committee, 
which must act under the procedure referred to in Article 33(3)." 

(3) 

In Article 14(1), the third subparagraph is replaced by the following: 

"A  list  of  such  designated  laboratories  shall  be  drawn  up  in  accordance  with  the 
procedure laid down in Article 33(3)." 

(4) 

In Article 15(1), the second subparagraph is replaced by the following: 

"The  detailed  rules  for  the  taking  of  official  samples  and  the  routine  and  reference 
methods to be employed for the analysis of such official samples shall be specified 
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 33(4)."  

EN 

56 

   EN 

(5) 

In Article 20(2), the sixth subparagraph is replaced by the following: 

"In  the  light  of  the  experts'  opinion,  appropriate  measures  may  be  taken  in 
accordance with the procedure referred to in Article 33(2)." 

(6) 

In Article 21, the second subparagraph of paragraph 1 and paragraph 2 are replaced 
by the following: 

"The  Member  State  concerned  shall  take  the  measures  necessary  to  take 
account of the results of these verifications and shall notify the Commission of 
the measures taken. Where the Commission considers that the measures taken 
are  insufficient,  it  shall,  after  consultation  with  the  Member  State  in  question 
and  having  regard  to  the  measures  necessary  to  safeguard  public  health,  take 
appropriate  measures  in  accordance  with  the  procedure  referred  to  in  Article 
33(2). 

2. 

The  general  rules  for  implementing  this  Article,  especially  as  regards  the 
frequency  and  method  of  carrying  out  the  verifications  referred  to  in  the  first 
subparagraph  of  paragraph  1  (including  cooperation  with  the  competent 
authorities), shall be determined in accordance with the procedure referred to in 
Article 33(3)." 

(7) 

In Article 29, paragraph 2 is replaced by the following: 

"2.  Where  the  requirements  of  paragraph  1  are  not  complied  with,  inclusion  of  a 
third country on the lists of third countries laid down by Community legislation 
or as a result of the benefit of pre-listing may be suspended in accordance with 
the procedure referred to in Article 33(3), at the request of a Member State or 
by the Commission on its own initiative." 

(8) 

In Article 30(3), the first subparagraph is replaced by the following: 

"3. 

If,  in  cases  involving  third  countries  which  have  concluded  equivalence 
agreements  with  the  Community,  the  Commission,  after  making  enquiries  of 
the competent authorities of the third countries concerned, concludes that they 
have  failed  to  fulfil  their  obligations  and  the  guarantees  given  by  the  plans 
referred  to  in  Article  29(1),  it  shall  cease  to  allow  that  country,  under  the 
procedure referred to in Article 33(2), to benefit from the said agreements for 
the  animals  and  products  in  question  until  the  third  country  in  question  has 
made good its shortcomings. The suspension shall be revoked under the same 
procedure." 

(9) 

Article 32 is deleted. 

(10) 

Article 33 is replaced by the following: 

"Article 33 

1. 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  the  Food 
Chain and Animal Health set up pursuant to Article 58 of Regulation (EC) No 
178/2002 (*). 

EN 

57 

   EN 

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

1999/468/EC shall apply. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at fifteen 

days. 

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

1999/468/EC shall apply. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 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. 

_____________________________ 

(*) OJ L 31, 1.2.2002, p. 1" 

5.4. 

Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 
January 1997 concerning novel foods and novel food ingredients32  

As  regards  Regulation  (EC)  No  258/97,  power  should  in  particular  be  conferred  on  the 
Commission to adopt data protection arrangements. Since those measures are of general scope 
and  are  designed  to  supplement  Regulation  (EC)  No  258/97  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 258/97 is amended as follows : 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

In Article 1(3), the words "Article 13" are replaced by the words "Article 13(2)". 

In  the  second  subparagraph  of  Article  3(4),  the  words  "Article  13"  are  replaced  by 
the words "Article 13(2)". 

In Article 4(5), the words "Article 13" are replaced by the words "Article 13(2)". 

In Article 7(1), the words "Article 13" are replaced by the words "Article 13(2)". 

In Article 8(3), the words "Article 13" are replaced by the words "Article 13(2)". 

Article 10 is replaced by the following: 

"Article 10 

Detailed rules for the protection of the information provided by the applicant shall be 
adopted  by  the  Commission.  Those  measures,  designed  to  amend  non-essential 

32 

OJ L 43, 14.2.1997, p. 1. 

EN 

58 

   EN 

                                                 
elements of this Regulation, by supplementing it, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 13(3)." 

In Article 12(2), the words "Article 13" are replaced by the words "Article 13(2)". 

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

(7) 

(8) 

"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." 

5.5. 

Decision  2119/98/EC  of  the  European  Parliament  and  of  the  Council  of  24 
September  1998  setting  up  a  network  for  the  epidemiological  surveillance  and 
control of communicable diseases in the Community33 

As regards Decision 2119/98/EC, power should in particular be conferred on the Commission 
to  establish  the  communicable  diseases  and  the  criteria  for  selection  of  these  diseases  to  be 
covered  by  the  Community  network,  as  well  as  the  epidemiological  and  microbiological 
surveillance methods. Since those measures are of general scope and are designed to amend 
non-essential elements of Decision 2119/98/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. 

With  a  view  to  making  the  Community  network  operative  and  effective  with  regard  to  the 
epidemiological  surveillance  and  to  the  achievement  of  uniform  information  within  this 
framework, the communicable diseases to be covered by the network, as well as the criteria 
for  the  selection  of  these  diseases  and  the  epidemiological  and  microbiological  surveillance 
methods,  should  be  determined  as  soon  as  the  disease  is  recognised.  On  the  grounds  of 
efficiency,  the  normal  time  limits  for  the  regulatory  procedure  with  scrutiny  should  be 
curtailed for the adoption of decisions determining the communicable diseases, the criteria for 
the  selection  of  these  diseases  and  the  epidemiological  and  microbiological  surveillance 
methods, as well as for the amendments to the Annex to Decision 2119/98/EC containing the 
list of categories of communicable diseases. 

When an emergency situation occurs with regard to the appearance or to new developments of 
a serious communicable disease, the epidemiological surveillance system should be triggered 
as  soon  as  possible,  in  order  to  ensure  protection  of  the  population  and  the  public  health. 
When on imperative grounds of urgency, the normal time limits 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 adoption of decisions 
determining the communicable diseases, the criteria for the selection of these diseases and the 
epidemiological and microbiological surveillance methods as well as for the amendments to 
the  Annex  to  Decision  2119/98/EC  containing  the  list  of  categories  of  communicable 
diseases. 

Accordingly, Decision 2119/98/EC is amended as follows: 

(1) 

Article 3 is amended as follows: 

33 

OJ  L  268,  3.10.1998,  p.  1.  Decision  as  last  amended  by  Regulation  (EC)  No  1882/2003  (OJ  L  284, 
31.10.2003, p. 1). 

EN 

59 

   EN 

                                                 
(a)  The introductory words are replaced by the following: 

"With a view to the effective operation of the Community network with regard 
to  epidemiological  surveillance  and  to  achieving  uniform  information 
within 
the 
Commission:" 

the  following  shall  be  adopted  by 

this  framework, 

(b)  The following second and third paragraphs are added:  

"The  measures  referred  to  in  points  (a),  (b)  and  (e),  designed  to  amend  non-
essential  elements  of  this  Decision,  inter  alia  by  supplementing  it,  shall 
be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred  to  in  Article  7(3).  On  imperative  grounds  of  urgency,  the 
Commission may use the urgent procedure referred to in Article 7(4). 

The measures referred to in points (c), (d), (f), (g) and (h) shall be adopted in 

accordance with the procedure referred to in Article 7(2)." 

(2) 

In Article 6, paragraph 5 is replaced by the following: 

"5.  Procedures  concerning  the  information  and  consultation  referred  to  in 
paragraphs 1, 2 and 3 and procedures concerning the coordination referred to in 
paragraphs  1  and  4  shall  be  established  in  accordance  with  the  procedure 
referred to in Article 7(2)." 

(3) 

Article 7 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 
(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  set  at  two  months,  one  month  and  two  months 
respectively." 

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." 

(4) 

Article 8 is replaced by the following: 

"Article 8 

The Annex may be amended or supplemented by the Commission. Those measures, 
designed  to  amend  non-essential  elements  of  this  Decision,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On 
imperative  grounds  of  urgency,  the  Commission  may  use  the  urgent  procedure 
referred to in Article 7(4)." 

EN 

60 

   EN 

5.6. 

Directive  2000/13/EC  of  the  European  Parliament  and  of  the  Council  of  20 
March 2000 on the approximation of the laws of the Member States relating to 
the labelling, presentation and advertising of foodstuffs34 

As  regards  Directive  2000/13/EC,  power  should  in  particular  be  conferred  on  the 
Commission to adopt certain measures necessary for its implementation. Since those 
measures are of general scope and are designed to amend non-essential elements of 
Directive  2000/13/EC  and/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. 

On  the  grounds  of  efficiency,  the  normal  time  limits  for  the  regulatory  procedure 
with scrutiny should be curtailed for the amendment of the lists of certain categories 
of ingredients. 

Accordingly, Directive 2000/13/EC is amended as follows : 

(1) 

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

"3.  The Community provisions referred to in paragraphs 1 and 2 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 20(3)." 

(2) 

Article 6 is amended as follows : 

(a) 

in paragraph 3a, second subparagraph, point (d) is replaced by the following: 

"(d)  as  regards  other  products,  being  measures  designed  to  amend  non-
essential  elements  of  this  Directive,  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 20(3)." 

(b) 

in  paragraph  6,  second  subparagraph,  the  second  indent  is  replaced  by  the 
following: 

"- 

ingredients belonging to one of the categories listed in Annex II must be 
designated by the name of that category, followed by their specific name 
or  EC  number;  if  an  ingredient  belongs  to  more  than  one  of  the 
categories, the category appropriate to the principal function in the case 
of the foodstuff in question shall be indicated; 

amendments to this Annex based on advances in scientific and technical 
knowledge,  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 20(4); 

however,  the  designation  ‘modified  starch’  listed  in  Annex  II  must 
always  be  complemented  by  the  indication  of  its  specific  vegetable 
origin, when that ingredient may contain gluten," 

34 

OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2006/142/EC (OJ L 368, 23.12.2006, 
p. 110).  

EN 

61 

   EN 

 
 
                                                 
(c) 

in paragraph 7, the third subparagraph is replaced by the following: 

"The Community provisions referred to in this paragraph 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 20(3)." 

(d) 

in paragraph 11, the third subparagraph is replaced by the following: 

"Without  prejudice  to  the  second  subparagraph,  Annex  IIIa  may  be  amended 
by  the  Commission,  after  an  opinion  has  been  obtained  from  the  European 
Food Safety Authority issued on the basis of Article 29 of Regulation (EC) No 
178/2002 of the European Parliament and of the Council of 28 January 2002, 
laying down the general principles and requirements of food law, establishing 
the European Food Safety Authority and laying down procedures in matters of 
food safety (*). 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 20(4)". 

(3) 

Article 7 is amended as follows : 

(a) 

in paragraph 2, point (d) is replaced by the following: 

"(d)  in the cases determined by the Commission; determination of such cases, 
a measure designed to amend non-essential elements of this Directive by 
supplementing  it,  shall  be  carried  out  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 20(3)." 

(b) 

in paragraph 3, point (d) is replaced by the following: 

"(d)  in the cases determined by the Commission; determination of such cases, 
a measure designed to amend non-essential elements of this Directive by 
supplementing  it,  shall  be  carried  out  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 20(3)." 

(c) 

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

"Such provisions shall be adopted 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 20(3)." 

(4) 

Article 8 is amended as follows : 

(a) 

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

"This list may be supplemented by the Commission. That measure, designed to 
amend non-essential elements of this Directive, shall be adopted in accordance 
with the regulatory procedure with scrutiny referred to in Article 20(3);" 

(b)  paragraph 6 is replaced by the following: 

EN 

62 

   EN 

"The Community provisions referred to in paragraphs 1, second subparagraph, 
2(b) and (d) and 5, second subparagraph, shall be adopted 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 20(3);"  

(5) 

In Article 11(2), the third subparagraph is replaced by the following: 

"The  Community  provisions  referred  to  in  this  paragraph  shall  be  adopted  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 20(3)." 

(6) 

In Article 16, paragraph 1 is replaced by the following: 

"1.  Member  States  shall  ensure  that  the  sale  is  prohibited  within  their  own 
territories of foodstuffs for which the particulars provided for in Article 3 and 
Article  4(2)  do  not  appear  in  a  language  easily  understood  by  the  consumer, 
unless  the  consumer  is  in  fact  informed  by  means  of  other  measures, 
determined as regards one or more labelling particulars. Determination of such 
measures,  a  measure  designed  to  amend  non-essential  elements  of  this 
Directive  by  supplementing  it,  shall  be  carried  out  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 20(3)." 

(7) 

Article 20 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) 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  set  at  two  months,  one  month  and  two  months 
respectively." 

(8) 

Article 21 is replaced by the following: 

"Article 21 

If temporary measures prove necessary to facilitate the application of this Directive, 
they 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 20(3). 

EN 

63 

   EN 

_____________________________ 

(*)  OJ  L  31,  1.2.2002,  p.1.  Regulation  as  amended  by  Regulation  (EC)  No 
1642/2003 (OJ L 245, 29.9.2003, p.4)" 

5.7. 

Directive 2001/37/EC of the European Parliament and of the Council of 5 June 
2001  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions of the Member States concerning the manufacture, presentation and 
sale of tobacco products35 

As  regards  Directive  2001/37/EC,  power  should  in  particular  be  conferred  on  the 
Commission to adopt rules for the use of colour photographs or the illustrations on 
tobacco products and to adapt the provisions on the measurements methods and on 
the health warnings to scientific and technical progress. Since those measures are of 
general  scope  and  are  designed  to  amend  non-essential  elements  of  Directive 
2001/37/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. 

Amendments  to  the  measurements  methodologies  are  measures  of  technical  nature 
based  on  scientific  advice  and  discussions  at  international  level  within  the  WHO 
Framework Convention on Tobacco Control and should be implemented within the 
EU  legislation  without  delay.  Therefore,  on  the  grounds  of  efficiency,  the  normal 
time  limits  for  the  regulatory  procedure  with  scrutiny  should  be  curtailed  for  the 
adaptation to scientific and technical progress of the measurements methods and the 
definitions relating thereto. 

Accordingly, Directive 2001/37/EC is amended as follows: 

(1) 

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

"The  rules  for  the  use  of  colour  photographs  or  other  illustrations  to  depict  and 
explain  the  health  consequences  of  smoking  shall  be  adopted  by  the  Commission 
with  a  view  to  ensuring  that  internal  market  provisions  are  not  undermined.  Those 
measures,  designed 
this  Directive  by 
to  amend  non-essential  elements  of 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 10(3)."  

(2) 

Article 9 is replaced by the following: 

"Article 9 

Adaptations 

1. 

The  adaptation  to  scientific  and  technical  progress  of  the  measurements 
methods  laid  down  in  Article  4  and  the  definitions  relating  thereto  shall  be 
decided by the Commission. Those measures, designed to amend non-essential 

35 

OJ L 194, 18.7.2001, p. 26. 

EN 

64 

   EN 

                                                 
elements of this Directive by supplementing it, shall be adopted in accordance 
with the regulatory procedure with scrutiny referred to in Article 10(4). 

2. 

The  adaptation  to  scientific  and  technical  progress  of  health  warnings  to  be 
shown  on  unit  packets  of  tobacco  products  as  set  out  in  Annex  I  and  the 
frequency  of  rotation  of  the  health  warnings  shall  be  decided  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 10(3). 

3. 

The Commission shall, in accordance with the procedure laid down in Article 
10(2), adapt to scientific and technical progress the marking for identification 
and tracing purposes of tobacco products."  

(3) 

Article 10 is replaced by the following: 

"Article 10 

Committee procedures 

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. 

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) 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 

limits 

laid  down 

(4(e)  of 
time 
Decision 1999/468/EC shall be set at two months, one month and two months 
respectively." 

in  Article  5a(3)(c), 

(4)(b)  and 

5.8. 

Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  of  3 
December 2001 on general product safety36 

As  regards  Directive  2001/95/EC,  power  should  in  particular  be  conferred  on  the 
Commission to set out and adapt the principal rules and procedures of notification of 
serious  risks  from  products.  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. 

36 

OJ L 11, 15.1.2002, p. 4. 

EN 

65 

   EN 

                                                 
On  grounds  of  efficiency  and  in  particular  because  the  adequacy  of  the  principal 
rules  and  procedures  regarding  notifications  of  serious  risks  from  products  is  a 
precondition for the proper functioning of the rapid alert system, the time limits for 
the regulatory procedure with scrutiny should be curtailed.  

Accordingly, Directive 2001/95/EC is amended as follows: 

(1) 

In Article 4(1), point (a) is replaced by the following: 

"(a) 

the  requirements  intended  to  ensure  that  products  which  conform  to  these 
standards  satisfy  the  general  safety  requirement  shall  be  determined  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 15(4);" 

(2) 

In Article 5(3), the second subparagraph is replaced by the following: 

"The Commission shall adapt the specific requirements relating to the obligation to 
provide information laid down in Annex I. 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 15(5)." 

(3) 

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

"Detailed procedures for RAPEX are set out in Annex II. They shall be adapted 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 15(5)." 

(4) 

Article 15 is replaced by the following: 

"1.  The Commission shall be assisted by a Committee. 

"Article 15 

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  period  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be  set  at  15 

days. 

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

EN 

66 

   EN 

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

5.9. 

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 
28  January  2002  laying  down  the  general  principles  and  requirements  of  food 
law,  establishing  the  European  Food  Safety  Authority  and  laying  down 
procedures in matters of food safety37  

As regards Regulation (EC) No 178/2002, power should in particular be conferred on 
the  Commission  to  adopt  provisions  relating  to  the  number  and  names  of  the 
Scientific Panels, the rules of procedure for submitting a request for an opinion to the 
Authority,  and  the  criteria  for  inclusion  of  an  institute  on  the  list  of  competent 
organisations designated by the Member States. Since those measures are of general 
scope  and  are  designed  to  amend  non-essential  elements  of  Regulation  (EC)  No 
178/2002  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 178/2002 is amended as follows :  

(1) 

In Article 28(4), the second subparagraph is replaced by the following: 

"The  number  and  names  of  the  Scientific  Panels  may  be  adapted  in  the  light  of 
technical and scientific development by the Commission, at the Authority's request. 
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 58(3)."  

(2) 

In Article 29, paragraph 6 is replaced by the following: 

"6.  The implementing rules for the application of this Article shall be established 
by the Commission after consulting the Authority. These rules shall specify in 
particular: 

(a) 

the procedure to be applied by the Authority to the requests referred to it; 

(b) 

the guidelines governing the scientific evaluation of substances, products 
or processes which are subject under Community legislation to a system 
of  prior  authorisation  or  entry  on  a  positive  list,  in  particular  where 
Community legislation makes provision for, or authorises, a dossier to be 
presented for this purpose by the applicant. 

The measure referred to in point (a), 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 58(3). 

37 

OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  No  575/2006  (OJ  L  100, 
8.4.2006, p. 3).  

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The guidelines referred to in point (b) shall be adopted in accordance with the 

procedure provided for in Article 58(2)."  

(3) 

In Article 36, paragraph 3 is replaced by the following: 

"3.  The implementing rules for the application of paragraphs 1 and 2 shall be laid 
down  by  the  Commission,  after  consulting  the  Authority.  Those  rules  shall 
specify,  in  particular,  the  criteria  for  inclusion  of  an  institute  on  the  list  of 
competent  organisations  designated  by  the  Member  States,  arrangements  for 
setting out harmonised quality requirements and the  financial  rules governing 
any  financial  support.  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 
58(3)."  

(4) 

In Article 58, paragraphs 2 and 3 are replaced by the following: 

"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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 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." 

5.10.  Regulation (EC) No 1774/2002 of the European Parliament and of the Council 
of 3 October 2002 laying down health rules concerning animal by-products not 
intended for human consumption38 

As  regards  Regulation  (EC)  No  1774/2002,  power  should  in  particular  be  conferred  on  the 
Commission  to  establish  rules  on  the  disposal,  processing,  importation/exportation  and 
transformation of Category 1, 2 and 3 material of animal by-products, as well as rules on the 
placing on the market of animal by-products coming from territories subject to animal health 
restrictions  and  of  organic  fertilizers  and  soil  improvers;  to  define  the  conditions  for  the 
importation from third countries of pet food and raw material for pet food production as well 
as  to  define  specific  or  alternative  hygiene  requirements  laid  down  in  the  Annexes.  Since 
those measures are of general scope and are designed to amend non-essential elements of that 
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. 

When, on imperative grounds of urgency, the normal time limits 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 adoption of the rules 
regarding  the  placing  on  the  market  of  animal  by-products,  or  products  deriving  therefrom, 
coming  from  territories  subject  to  animal  health  restrictions,  for  the  adoption  of  alternative 

38 

OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 829/2007 
(OJ L 191, 21.7.2007, p. 1). 

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rules  for  specific  situations  regarding  the  placing  on  the  market  of  animal  by-products,  or 
products deriving therefrom, coming from territories subject to animal health restrictions and 
for the amendments of the Annexes.  

Accordingly, Regulation (EC) No 1774/2002 is amended as follows: 

(1) 

In Article 3, paragraph 2 is replaced by the following: 

"2.  However, Member States may regulate under national law the importation and 
placing  on  the  market  of  products  not  referred  to  in  Annexes  VII  and  VIII, 
pending  the  adoption  of  a  decision  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  33(3).  Member  States  shall  immediately  inform  the 
Commission of the use that they make of this possibility." 

(2) 

Article 4 is amended as follows: 

(a) 

In paragraph 2, point (e) is replaced by the following: 

"(e) 

in the light of developments in scientific knowledge, disposed of by other 
means  that  are  approved  by  the  Commission  after  consultation  of  the 
appropriate  scientific  committee.  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  33(3).  These  means  may  either  supplement  or 
replace those provided for in points (a) to (d) of this paragraph." 

(b) 

In paragraph 4, the first sentence is replaced by the following: 

"Category  1  material  shall  not  be  imported  or  exported  except  in  accordance 
with  this  Regulation  or  with  rules  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 33(3)." 

(3) 

Article 5 is amended as follows: 

(a)  Paragraph 2 is amended as follows: 

(i) 

In point (c), point (i) is replaced by the following: 

"(i) 

in the case of resulting proteinaceous material, used as an organic 
fertilizer or soil improver in compliance with requirements, if any, 
laid down by the Commission after consultation of the appropriate 
scientific  committee;  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 33(3)," 

(ii)  Point (d) is replaced by the following: 

EN 

69 

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"(d)  in  the  case  of  material  of  fish  origin,  ensiled  or  composted  in 
compliance with rules 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 33(3);" 

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

"(iii)  transformed  in  a  biogas  plant  or  composted  in  accordance  with 
rules  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 33(3);" 

(iv)  Point (g) is replaced by the following: 

"(g)  disposed  of  by  other  means,  or  used  in  other  ways,  in  accordance 
with  rules  laid  down  by  the  Commission  after  consultation  of  the 
appropriate  scientific  committee;  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  33(3)  .  These  means  or  ways 
may either supplement or replace those provided for in points (a) to 
(f) of this paragraph." 

(b)  Paragraph 4 is replaced by the following: 

"4.  Category 2 material shall not be placed on the market or exported except 
in  accordance  with  this  Regulation  or  with  rules  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 33(3)." 

(4) 

In Article 6(2), points (g), (h) and (i) are replaced by the following: 

"(g)  in  the  case  of  catering  waste  referred  to  in  paragraph  1(l),  transformed  in  a 
biogas  plant  or  composted  in  accordance  with  rules  laid  down  by  the 
Commission,  or,  pending  the  adoption  of  such  rules,  in  accordance  with 
national law; 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 33(3); 

(h) 

(i) 

in the case of material of fish origin, ensiled or composted in accordance with 
rules  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 
33(3); or 

disposed  of  by  other  means,  or  used  in  other  ways,  in  accordance  with  rules 
laid  down  by  the  Commission  after  consultation  of  the  appropriate  scientific 
committee;  those  measures  designed  to  amend  non-essential  elements  of  this 
Regulation  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 

EN 

70 

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regulatory procedure with scrutiny referred to in Article 33(3). These means or 
ways may either supplement or replace those provided for in points (a) to (h)." 

(5) 

In Article 12, paragraph 5 is replaced by the following: 

"5.  The requirements of paragraphs 2 and 3 may be amended by the Commission 
in the light of developments in scientific knowledge,  after consultation  of the 
appropriate  scientific  committee.  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 33(3)." 

(6) 

In Article 16, paragraph 3 is amended as follows: 

(a)  Point (d) is replaced by the following: 

"(d)  comply  with  the  requirements  laid  down  in  Annexes  VII  and  VIII,  or 
with detailed rules to 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  33(3).  On  imperative 
grounds  of  urgency,  the  Commission  may  use  the  urgent  procedure 
referred to in Article 33(4). 

(b) 

In the second subparagraph, the first sentence is replaced by the following: 

"Conditions  alternative  to  those  set  out  in  the  first  subparagraph  may  be  laid 
down  in  specific  situations  by  decisions  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  33(3).  On  imperative  grounds  of  urgency, 
the Commission may use the urgent procedure referred to in Article 33(4)." 

(7) 

In Article 20, paragraph 2 is replaced by the following: 

"2.  Member States shall ensure that organic fertilizers and soil improvers produced 
from processed products, other than those produced from manure and digestive 
tract  content,  are  placed  on  the  market  or  exported  only  if  they  meet 
requirements,  if  any,  laid  down  by  the  Commission  after  consultation  of  the 
appropriate  scientific  committee.  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 
33(3)" 

(8) 

In Article 22, paragraph 2 is replaced by the following: 

"2.  Rules for the implementation of this Article, including rules concerning control 
measures,  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 33(2). Derogations from paragraph 1(a) of this Article may be granted 
by the Commission in relation to fish and fur animals, after consultation of the 
appropriate  scientific  committee.  Those  measures,  designed  to  amend  non-
essential elements of this Regulation by supplementing it, shall be adopted in 

EN 

71 

   EN 

accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
33(3)." 

(9) 

Article 23 is amended as follows: 

(a) 

In paragraph 2, point d) is replaced by the following: 

"(d)  In addition, Member States may authorise the use, under the supervision 
of the competent authorities, of Category 1 material referred to in Article 
4(1)(b)(ii)  for  the  feeding  of  endangered  or  protected  species  of 
necrophagous  birds  in  accordance  with  rules  laid  down  by  the 
Commission  after  consultation  of  the  European  Food  Safety  Authority. 
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 33(3)." 

(b)  Paragraph 5 is replaced by the following: 

"5.  Detailed  rules  concerning  verification  measures  may  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 33(3)." 

(10) 

In Article 25, paragraph 3 is replaced by the following: 

"3.  Detailed  arrangements  for 

implementing 

including  rules 
concerning the frequency of checks and reference methods for microbiological 
analyses, may 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 33(3)." 

this  Article, 

(11) 

In Article 26, paragraph 5 is replaced by the following: 

"5.  Detailed  arrangements  for 

implementing 

including  rules 
concerning the frequency of checks and reference methods for microbiological 
analyses, may 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 33(3)." 

this  Article, 

(12) 

In Article 28, the second paragraph is replaced by the following: 

"However,  the  importation  from  third  countries  of  petfood  and  raw  material  for 
petfood  production,  derived  from  animals  which  have  been  treated  with  certain 
substances  prohibited  in  accordance  with  Directive  96/22/EC,  shall  be  permitted 
provided that such raw material is permanently marked and under specific conditions 
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 33(3)." 

(13) 

In Article 32, paragraph 1 is replaced by the following: 

EN 

72 

   EN 

"1.  After consultation of the appropriate scientific committee on any question that 
could have an impact on animal or public health, the Annexes may be amended 
or supplemented and any appropriate transitional measures 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  33(3).  On  imperative  grounds  of  urgency, 
the Commission may use the urgent procedure referred to in Article 33(4)."  

(14) 

Article 33 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)  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." 

(15) 

In Annex II, Chapter III, point 4 is replaced by the following: 

"4.  A model for the commercial document may 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 33(3)." 

(16) 

In Annex III, Chapter II, Part B, point 11 is replaced by the following: 

"11.  Waste water must be treated to ensure, as far as is reasonably practicable, that 
no  pathogens  remain.  Specific  requirements  for  the  treatment  of  waste  water 
from Category 1 and Category 2 intermediate plants may 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 33(3)." 

(17) 

Annex V is amended as follows: 

(a) 

In Chapter II, point 4 is replaced by the following: 

"4.  Waste water originating in the unclean sector must be treated to ensure, 
as  far  as  is  reasonably  practicable,  that  no  pathogens  remain.  Specific 
requirements  for  the  treatment  of  waste  water  from  processing  plants 
may  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 33(3)." 

(b) 

In Chapter V, point 5 is replaced by the following: 

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73 

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"5.  Validation procedures based on testing methods may 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 33(3)." 

(18) 

Annex VI is amended as follows: 

(a) 

In Chapter I, Part C, point 8 is replaced by the following: 

"8.  Processed  products  derived  from  Category  1  or  2  material,  with  the 
exception  of  liquid  products  destined  for  biogas  or  composting  plants, 
must  be  permanently  marked,  where  technically  possible  with  smell, 
using  a  system  approved  by  the  competent  authority.  Detailed  rules  for 
such  marking  may  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 33(3)." 

(b) 

In Chapter III, point 2(b) is replaced by the following: 

"(b)  in a continuous process at 140°C 2 bars (2000 hPa) for eight minutes, or 
under  equivalent  conditions  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 33(3)." 

(19) 

Annex VII is amended as follows: 

(a) 

In Chapter II, Part C, point 13(b) is replaced by the following: 

"(b)  reprocessed in a processing plant approved pursuant to this Regulation or 
decontaminated by a treatment authorised by the competent authority. A 
list of permitted treatments may be 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  33(3).  The  consignment 
must not be released until it has been treated, tested for salmonella by the 
competent  authority  in  accordance  with  Chapter  I,  paragraph  10,  and  a 
negative result obtained." 

(b)  Chapter V is amended as follows: 

(i) 

In Part A, point 1 is replaced by the following: 

"1.  Raw  milk  and  colostrum  must  be  produced  under  conditions 
offering  adequate  guarantees  as  regards  animal  health.  Such 
the  Commission.  Those 
conditions  may  be  established  by 
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 
33(3)." 

EN 

74 

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(ii) 

In Part B, point 6 is replaced by the following: 

"6.  Where a risk of introduction of an exotic disease or any other risk 
to  animal  health  is  identified,  additional  conditions  for  the 
protection of animal health may be 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 
33(3)." 

(c) 

In Chapter VI, Part B, point 3(c) is replaced by the following: 

"(c)  an  equivalent  production  process  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 33(3)." 

(d) 

In Chapter VII, Part A, point 1 is replaced by the following: 

"1.  Dicalcium phosphate must be produced by a process that: 

(a) 

(b) 

(c) 

ensures  that  all  Category  3  bone-material  is  finely  crushed  and 
degreased with hot water and treated with dilute hydrochloric acid 
(at a minimum concentration of 4 % and a pH of less than 1,5) over 
a period of at least two days; 

following the procedure at (a), applies a treatment of the obtained 
phosphoric liquor with lime, resulting in a precipitate of dicalcium 
phosphate at pH 4 to 7; and 

finally  air  dries  the  precipitate  of  dicalcium  phosphate  with  inlet 
temperature of 65°C to 325°C and end temperature between 30°C 
and 65°C, or 

by an equivalent process 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 33(3)." 

(e) 

In Chapter VIII, Part A, point 1 is replaced by the following: 

"1.  Tricalcium phosphate must be produced by a process that ensures: 

(a) 

(b) 

(c) 

that all Category 3 bone-material is finely crushed and degreased in 
counter-flow with hot water (bone chips less than 14 mm); 

continuous  cooking  with  steam  at  145°C  during  30  minutes  at  4 
bars; 

separation of the protein broth from the hydroxyapatite (tricalcium 
phosphate) by centrifugation; and 

EN 

75 

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(d)  granulation of the tricalcium phosphate after drying in a fluid bed 

with air at 200°C; or 

by an equivalent production process 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 33(3)." 

(20) 

Annex VIII is amended as follows: 

(a)  Chapter IV, Part A, is amended as follows: 

(i) 

In point 3(b)(ii), the fourth indent is replaced by the following: 

"- 

any  other  treatment  provided  for  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 
33(3)." 

(ii)  Point 4 is replaced by the following: 

"4.  The  specific  conditions  relating  to  imports  of  products  for  use  in 
vitro  diagnosis  and  laboratory  reagents  may  be  laid  down  by  the 
Commission, where necessary. 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 33(3)." 

(b) 

In Chapter VI, Part A, point 2(e) is replaced by the following: 

"(e)  preserved by a process other than tanning specified 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 33(3)." 

(c) 

In Chapter VII, Part A, point 4(a)(iii) is replaced by the following: 

"(iii)  preserved  by  a 

treatment  other 

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 33(3)." 

tanning  approved  by 

than 

5.11.  Directive  2002/98/EC  of  the  European  Parliament  and  of  the  Council  of  27 
January 2003 setting standards of quality and safety for the collection, testing, 
processing, storage and distribution of human blood and blood components and 
amending Directive 2001/83/EC39 

As regards Directive 2002/98/EC, power should in particular be conferred on the Commission 
to  adapt  the  technical  requirements  set  out  in  Annexes  I  to  IV  to  technical  and  scientific 

39 

OJ L 33, 8.2.2003, p. 30. 

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76 

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progress. Since those measures are of general scope and are designed to amend non-essential 
elements of Directive 2002/98/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. 

Regarding storage, transport, distribution, quality and safety of blood, as well as requirements 
applicable to autologous transfusions, discussions are currently ongoing within the Council of 
Europe.  If  progress  is  being  made  in  this  context  and  new  internationally  recognized 
conditions  appear,  the  EU  legislation  should  be  adapted  accordingly  without  delay.  On 
grounds  of  efficiency,  the  normal  time  limits  for  the  regulatory  procedure  with  scrutiny 
should  be  curtailed  for  the  adaptation  of  the  technical  requirements  related  to  storage, 
transport,  distribution,  quality  and  safety  of  blood,  as  well  as  requirements  applicable  to 
autologous transfusions, set out in Annexes I to IV, to scientific and technical progress. 

In  the  event  that  scientific  and  technical  developments  indicate  that  additional  information 
should  be  provided  to  or  obtained  from  donors,  in  order  to,  for  instance,  exclude  donors 
presenting a health risk to others, an adaptation should be made without delay. Similarly, if 
scientific  progress  suggests  new  eligibility  criteria  concerning  the  suitability  of  blood  and 
plasma  donors,  new  deferral  criteria  should  be  added  to  the  list  immediately.  When  on 
imperative  grounds  of  urgency,  the  normal  time  limits  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  the  technical 
requirements  concerning  information  to  be  provided  to  or  obtained  from  donors,  as  well  as 
requirements related to the suitability of blood and plasma donors, set out in annexes I to IV, 
to scientific and technical progress. 

Accordingly, Directive 2002/98/EC is amended as follows: 

(1) 

Article 28 is replaced by the following: 

"Article 28 

Committee Procedures 

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 period referred to in Article 5(6) of Decision 1999/468/EC shall be set at 
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. 

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.  

EN 

77 

   EN 

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

(2) 

Article 29 is amended as follows: 

(a)  The first paragraph is replaced by the following: 

"The  adaptation  of  the  technical  requirements  set  out  in  Annexes  I  to  IV  to 
technical  and  scientific  progress  shall  be  decided  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  28(3).  On  imperative  grounds  of  urgency, 
the  Commission  may  use  the  urgent  procedure  referred  to  in  Article  28(5)  as 
regards technical requirements set out in Annexes III and IV." 

(b) 

In the second paragraph, the introductory phrase is replaced by the following: 

"The  following  technical  requirements  and  their  adaptation  to  technical  and 
scientific progress shall be decided by the Commission:" 

(c)  The following paragraphs are added: 

Technical  requirements  referred  to  in  points  (a),  (h)  and  (i)  of  the  second 
paragraph,  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 28(3). 

Technical requirements referred to in points (b), (c), (d), (e), (f) and (g), of the 
second paragraph, 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 28(4). On imperative 
grounds of urgency the Commission may use the urgent procedure referred to 
in Article 28(5) as regards technical requirements referred to in points (b), (c) 
and (d) of the second paragraph."  

5.12.  Regulation (EC) No 1831/2003 of the European Parliament and of the Council 

of 22 September 2003 on additives for use in animal nutrition40 

As regards Regulation (EC) No 1831/2003, power should in particular be conferred 
on  the  Commission  to  establish,  as  a  result  of  technological  progress  or  scientific 
development,  additional  feed  additive  categories  and  functional  groups,  to  adopt 
amendments  to  Annex  III  and  to  the  general  conditions  of  Annex  IV  to  take 
technological  progress  and  scientific  development  into  account  and  to  adopt 
amendments to Annex II. Since those measures are of general scope and are designed 

40 

OJ L 268, 18.10.2003, p. 29. 

EN 

78 

   EN 

                                                 
to  amend  non-essential  elements  of  Regulation  (EC)  No  1831/2003,  they  must  be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  provided  for  in 
Article 5a of Decision 1999/468/EC.  

Additives for use in animal nutrition are substances, micro-organisms or preparations 
which are intentionally added to feed or water in order to perform, in particular, one 
or  more  of  the  following  functions:  satisfy  the  nutritional  needs  of  animals, 
favourably  affect  the  characteristics  of  feed  or  animal  products,  the  colour  of 
ornamental  fish  and  birds,  the  environmental  consequences  of  animal  production, 
animal production, performance or welfare. In order to guarantee the improvements 
produced  by  the  use  of  such  additives  and,  consequently,  an  increase  in  the 
productivity and quality of animal production, access of additives to the market must 
be  made  easy  and  rapid.  On  grounds  of  efficiency,  the  normal  time  limits  for  the 
regulatory procedure with scrutiny should therefore be curtailed for the adoption of 
those measures establishing additional feed additive categories and functional groups 
and for amendments to Annexes II , III and IV. 

Accordingly, Regulation (EC) No 1831/2003 is amended as follows: 

(1) 

Article 3(5), is replaced by the following: 

"5.  Where  necessary,  as  a  result  of 

technological  progress  or  scientific 
development,  the  Commission  may  adapt  the  general  conditions  set  out  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 22(4)." 

(2) 

Article 6(3) is replaced by the following:  

"3.  Where  necessary,  as  a  result  of 

technological  progress  or  scientific 
development, 
the  Commission  shall  establish  additional  feed  additive 
categories  and  functional  groups.  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 
22(4)." 

(3) 

In Article 7(5), the second subparagraph is replaced by the following: 

"After the Authority has been consulted, further rules for the implementation of this 
Article  may  be  established  by  the  Commission.  These  rules  should,  where 
appropriate, differentiate between requirements for feed additives in respect of food-
producing  animals  and  requirements  in  respect  of  other  animals,  in  particular  pets. 
The  implementing  rules  shall  include  provisions  which  allow  for  simplified 
procedures for the authorisation of additives which have been authorised for use in 
food. 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 22(3)." 

(4) 

Article 16(6) is replaced by the following:  

"The  Commission  may  adopt  amendments  to  Annex  III  to  take  technological 
progress  and  scientific  development  into  account.  Those  measures,  designed  to 

EN 

79 

   EN 

amend non-essential elements of this Regulation, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 22(4)." 

(5) 

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

"Detailed rules for implementing Annex II and any amendments to that Annex shall 
be adopted in accordance with the procedure referred to in Article 22(2). 

Annex II may be amended 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 22(4)." 

(6) 

Article 22 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)  paragraph 4 is 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  set  at  two  months,  one  month  and  two 
months respectively." 

5.13.  Regulation (EC) No 2065/2003 of the European Parliament and of the Council 
of  10  November  2003  on  smoke  flavourings  used  or  intended  for  use  in  or  on 
foods41 

As  regards  Regulation  (EC)  No  2065/2003,  power  should  in  particular  be  conferred  on  the 
Commission to adopt amendments to the Annexes. Since those measures are of general scope 
and are designed to amend non-essential elements of Regulation (EC) No 2065/2003 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 2065/2003 is amended as follows:  

(1) 

Article 18 is replaced by the following: 

41 

OJ L 309, 26.11.2003, p. 1. 

EN 

80 

   EN 

                                                 
"Article 18 

Amendments 

1.  Amendments  to  the  Annexes  shall  be  adopted  by  the  Commission  following 
consultation  of  the  Authority  for  scientific  and/or  technical  assistance.  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 19(3). 

2.  Amendments  to  the  list  referred  to  in  Article  6(1)  shall  be  adopted  in 
accordance  with  the  procedure  referred  to  in  Article  19(2)  following 
consultation of the Authority for scientific and/or technical assistance." 

(2) 

In Article 19, 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." 

5.14.  Regulation (EC) No 2160/2003 of the European Parliament and of the Council 
of  17  November  2003  on  the  control  of  salmonella  and  other  specified  food-
borne zoonotic agents42 

As  regards  Regulation  (EC)  No  2160/2003,  power  should  in  particular  be  conferred  on  the 
Commission to adopt Community targets for the reduction of the prevalence of zoonoses and 
zoonotic  agents,  specific  control  methods  and  specific  rules  concerning  the  criteria  for  the 
evaluation  of  the  testing  methods,  and  to  lay  down  the  responsibilities  and  tasks  of  the 
reference  laboratories  and  the  rules  for  the  implementation  of  Community  controls.  Since 
those measures are of general scope and are designed to amend non-essential elements of that 
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 2160/2003 is amended as follows: 

(1) 

Article 4 is amended as follows: 

(a) 

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

"The targets, and any amendments to them, shall be established 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 14(3)." 

(b) 

In paragraph 6, point (a) is replaced by the following: 

42 

OJ  L  325,  12.12.2003,  p.  1.  Regulation  as  last  amended  by  Commission  Regulation  (EC)  No 
1237/2007, p. 5). 

EN 

81 

   EN 

                                                 
"(a)  Annex I may be amended by the Commission for the purposes listed in 
point (b), after taking account in particular of the criteria listed in point 
(c).  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 14(3)." 

(c)  Paragraph 7 is replaced by the following: 

"7.  Annex III may be amended or supplemented 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 14(3)." 

(2) 

In Article 5, paragraph 6 is replaced by the following: 

"6.  The requirements and minimum sampling rules laid down in Annex II may be 
amended, adapted or supplemented by the Commission, after taking account in 
particular  of  the  criteria  listed  in  point  (c)  of  Article  4(6).  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 
14(3)." 

(3) 

In Article 8, paragraph 1 is amended as follows: 

(a)  The introductory words are replaced by the following: 

"At the initiative of the Commission or at the request of a Member State:" 

(b)  The following second subparagraph is added: 

"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) 

In Article 9, paragraph 4 is replaced by the following: 

"4.  Without  prejudice  to  Article  5(6),  specific  rules  concerning  the  setting  by 
Member States of the criteria referred to in Article 5(5) and in paragraph 2 of 
this Article may 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)." 

(5) 

Article 10 is amended as follows: 

(a) 

In paragraph 4, the second sentence is replaced by the following: 

"Flocks  and  herds  shall  be  tested  for  the  zoonoses  and  zoonotic  agents  listed  in 
Annex I, column 1, or, if necessary to achieve the objective of equivalent guarantees 
laid down in paragraph 1, such zoonoses and zoonotic agents as may be specified by 
the Commission; those measures, designed  to amend  non-essential elements of  this 

EN 

82 

   EN 

Regulation,  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in Article 14(3)." 

(b)  Paragraph 5 is replaced by the following:  

"5.  The Member State of final destination may be authorised, in accordance 
with  the  procedure  referred  to  in  Article  14(2),  to  require  for  a 
transitional period that the results of the testing referred to in paragraph 4 
of this Article fulfil the same criteria as those laid down under its national 
programme,  in  accordance  with  Article  5(5).  The  authorisation  may  be 
withdrawn  and,  without  prejudice  to  Article  5(6),  specific  rules 
concerning  such  criteria  may  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)." 

(6) 

Article 11 is amended as follows: 

(a)  Paragraph 2 is replaced by the following:  

"2.  The  responsibilities  and  tasks  of  the  Community  reference  laboratories, 
in  particular  with  regard  to  coordination  of  their  activities  and  those  of 
the  national  reference 
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)." 

laboratories,  shall  be 

laid  down  by 

(b)  Paragraph 4 is replaced by the following: 

"4.  Certain responsibilities and tasks of the national reference laboratories, in 
particular with regard to coordination of their activities and those of the 
relevant  laboratories  in  the  Member  States  designated  under  Article 
12(1)(a),  may  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)." 

(7) 

In Article 12(3), the third subparagraph is replaced by the following: 

"Where necessary, other methods for testing  may be 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 14(3)." 

(8) 

Article 13 is replaced by the following: 

EN 

83 

   EN 

"Article 13 

Implementing and transitional measures 

transitional  or 

implementing  measures, 

the  necessary 
Appropriate 
amendments to the relevant health certificates, may be adopted 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 14(3)." 

including 

(9) 

In Article 14, 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." 

(10) 

In Article 17, paragraph 2 is replaced by the following:  

"2. 
Rules  for  the  implementation  of  this  Article,  in  particular  those  governing  the 
procedure  for  cooperation  with  national  competent  authorities,  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)." 

5.15.  Directive  2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31 
March  2004  on  setting  standards  of  quality  and  safety  for  the  donation, 
procurement,  testing,  processing,  preservation,  storage  and  distribution  of 
human tissues and cells43 

As regards Directive 2004/23/EC, power should in particular be conferred on the Commission 
to  establish  traceability  requirements  for  tissues  and  cells  and  the  related  procedures  of 
enforcement  as  well  as  certain  technical  requirements  regarding,  inter  alia,  an  accreditation 
system for tissue establishments and donation, procurement, testing, processing, preservation, 
storage and distribution of human tissues and cells. 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  must  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

The  use  of  tissues  and  cells  for  application  in  the  human  body  carries  a  risk  of  disease 
transmission  and  other  potential  adverse  effects  in  recipients.  That  risk  can  be  reduced  by 
careful donor selection and testing of each donation. In particular, due to scientific progress, 
new  eligibility  criteria  to  select  donors  and  new  requirement  for  laboratory  tests  could  be 
developed and should, therefore, be implemented within the EU legislation without delay in 
order  to  exclude  potential  donors  who  might  present  a  health  risk  to  other  people.  On  the 
grounds  of  efficiency,  the  normal  time  limits  for  the  regulatory  procedure  with  scrutiny 
should  be  curtailed  for  the  adoption  of  decisions  concerning  the  selection  criteria  for  the 
donor of tissues and/or cells and the laboratory tests required for donors.  

43 

OJ L 102, 7.4.2004, p. 48. 

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84 

   EN 

                                                 
Storage, transport and distribution of tissue and cells are a subject under discussion within the 
Council  of  Europe.  Any  progress  made  in  this  context  giving  rise  to  new  internationally 
recognized conditions should be implemented within the EU legislation without delay. On the 
grounds  of  efficiency,  the  normal  time  limits  for  the  regulatory  procedure  with  scrutiny 
should  be  curtailed  for  the  adoption  of  decisions  concerning  tissue  and  cell  processing, 
storage and distribution. 

In  the  event  that  scientific  and  technical  developments  on  selection  criteria  and  laboratory 
tests  for  donors  provide  for  a  new  evidence  of  diseases  transmissible  through  donation, 
prompt adaptation of Community legislation should follow consequently. When on imperative 
grounds of urgency, the normal time limits 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 adoption of decisions concerning the selection 
criteria for the donor of tissues and/or cells and the laboratory tests required for donors. 

Accordingly, Directive 2004/23/EC is amended as follows: 

(1) 

Article 8 is amended as follows: 

(a) 

paragraph 5 is replaced by the following: 

"5.  The traceability requirements for tissues and cells, as well as for products 
and materials coming into contact with these tissues and cells and having 
an effect on their quality and safety, 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 29(3)." 

(b)  paragraph 6 is replaced by the following: 

"6.  The  procedures  for  ensuring  traceability  at  Community  level  shall  be 
established 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 29(3)." 

(2) 

(a) 

Article 28 is amended as follows: 

The introductory phrase is replaced by the following: 

"The  following  technical  requirements  and  their  adaptation  to  scientific  and 
technical progress shall be decided by the Commission:" 

(b)  The following paragraphs are added:  

"1.  Technical requirements referred to in points (a), (b), (c), (f), (g) and (i), 
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 29(3).  

2. 

Technical  requirements  referred  to  in  points  (d),  (e)  and  (h)  ,measures 
this  Directive  by 
designed 

to  amend  non-essential  elements  of 

EN 

85 

   EN 

 
supplementing  it,  shall  be  adopted  in  accordance  with  the  regulatory 
procedure  with  scrutiny  referred  to  in  Article  29(4).  On  imperative 
grounds  of  urgency  the  Commission  may  use  the  urgent  procedure 
referred to in Article 29(5) as regards technical requirements referred to 
in points (d) and (e) of Article 28."  

(4) 

Article 29 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 

limits 

laid  down 

in  Article  5a(3)(c),  (4)(b)  and  (4(e)  of 
time 
Decision 1999/468/EC  shall  be  set  at  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." 

5.16.  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 
29  April  2004  on  official  controls  performed  to  ensure  the  verification  of 
compliance with feed and food law, animal health and animal welfare rules44 

As  regards  Regulation  (EC)  No  882/2004,  power  should  in  particular  be  conferred  on  the 
Commission to adopt implementing measures concerning methods of sampling and analysis, 
to lay down the conditions in which special treatment may take place, to update the minimum 
rates for any fees or charges, to determine the circumstances in which official certification is 
required, to amend and update the lists of Community reference laboratories, to lay down the 
criteria  for  assessing  the  risk  of  products  exported  to  the  Community  and  specific  import 
conditions.  Since  those  measures  are  of  general  scope  and  are  designed  to  amend  non-
essential  elements  of  that  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 882/2004 is amended as follows : 

(1) 

In Article 11, paragraph 4 is amended as follows :  

(a) 

the introductory phrase is replaced by the following: 

44 

OJ L 165, 30.4.2004, p. 1; corrected version: OJ L 191, 28.5.2004, p. 1. Regulation as last amended by 
Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). 

EN 

86 

   EN 

                                                 
"The following implementing measures may be taken by the Commission:" 

(b) 

the following second subparagraph is added: 

"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 62(4)." 

(2) 

In Article 20, paragraph 2 is replaced by the following:  

"2.  The  competent  authority  shall  ensure  that  special  treatment  takes  place  in 
establishments under its control, or under the control of another Member State, 
and  in  accordance  with  conditions  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 62(4). In the absence of such conditions, the 
special treatment shall take place in accordance with national rules." 

(3) 

In Article 27(3), the second subparagraph is replaced by the following: 

"The rates in Annex IV, Section B and Annex V, Section B shall be updated by the 
Commission at least every two years, in particular to take account of inflation. 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 62(4)." 

(4) 

In Article 30, paragraph 1 is amended as follows: 

(a) 

the introductory phrase is replaced by the following: 

"Without  prejudice  to  requirements  concerning  official  certification  adopted  for 
animal  health  or  animal  welfare  purposes,  requirements  may  be  adopted  by  the 
Commission concerning:" 

(b) 

the following second and third subparagraphs are added: 

"The measures referred to in point (a), 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 62(4). 

The measures referred to in points (b) to (g) shall be adopted, in accordance with the 
procedure referred to in Article 62(3)." 

(5) 

In Article 32, paragraph 5 is replaced by the following: 

"5.  Other  Community  reference  laboratories  relevant  to  the  areas  referred  to  in 
Article 1 may be included in Annex VII 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 
62(4). In accordance with the same procedure, Annex VII may be updated." 

(6) 

In Article 46(3), the second subparagraph is replaced by the following: 

EN 

87 

   EN 

"The criteria for determining risk for the purpose of the risk assessment referred to in 
point (a)  shall be  decided 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 62(4)." 

(7) 

In Article 48, paragraph 1 is replaced by the following: 

"1.  To the extent that the conditions and detailed procedures to be respected when 
importing  goods  from  third  countries  or their  regions  are  not  provided  for  by 
Community law and in particular by Regulation (EC) No 854/2004, they shall, 
if  necessary,  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 62(4)."  

(8) 

In Article 62, 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." 

(9) 

In Article 63, paragraph 2 is replaced by the following: 

"2. 

In  order  to  take  account  of  the  specificity  of  Regulations  (EEC)  No  2092/91, 
(EEC) No 2081/92 and (EEC) No 2082/92, specific measures to be adopted by 
the  Commission  may  provide  for  the  necessary  derogations  from  and 
adjustments  to  the  rules  laid  down  in  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 62(4)." 

(10) 

Article 64 is replaced by the following: 

"Article 64 

Amendment of Annexes and references to European standards 

The  following  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 62(4): 

(1) 

the Annexes to this Regulation may be updated, except for Annex I, Annex IV 
and Annex V, without prejudice to Article 27(3), in particular in order to take 
account of administrative changes and scientific and/or technological progress; 

(2) 

the references to the European standards referred to in this Regulation may be 
updated in the event that CEN amends these references." 

EN 

88 

   EN 

5.17.  Regulation (EC) No 1935/2004 of the European Parliament and of the Council 
of 27 October 2004 on materials and articles intended to come into contact with 
food and repealing Directives 80/590/EEC and 89/109/EEC45 

As  regards  Regulation  (EC)  No  1935/2004,  power  should  in  particular  be  conferred  on  the 
Commission  to  adopt  specific  measures  for  groups  of  materials  and  articles,  Community 
authorisation  of  a  substance,  as  well  as  its  modification,  suspension  or  revocation  of  this 
authorisation.  Since  those  measures  are  of  general  scope  and  are  designed  to  amend  non-
essential elements of Regulation (EC) No 1935/2004 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. 

In order to strengthen competitiveness and innovation of the European industry, materials and 
articles intended to come into contact with food should be marketed as soon as possible once 
their  safety  has  been  established.  On  grounds  of  efficiency,  the  normal  time  limits  for  the 
regulatory procedure with scrutiny should be curtailed for the adoption of a list of substances 
authorised  for  use  in  the  manufacturing  of  materials  and  articles;  list(s)  of  authorised 
substances  incorporated  in  active  or  intelligent  food  contact  materials  and  articles,  list(s)  of 
active or intelligent materials and articles and, when necessary, special conditions of use for 
these  substances  and/or  the  materials  and  articles  in  which  they  are  incorporated;  purity 
standards; special conditions of use for certain substances and/or the materials and articles in 
which  they  are  used;  specific  limits  on  the  migration  of  certain  constituents  or  groups  of 
constituents  into  or  on  to  food;  amendments  of  existing  specific  directives  on  materials  and 
articles; Community authorisations as well as their modification, suspension or revocation. 

When, on imperative grounds of urgency, the normal time limits 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 adoption of specific 
measures regarding the modification, suspension or revocation of Community authorisations. 

Accordingly, Regulation (EC) No 1935/2004 is amended as follows: 

(1) 

Article 5 is amended as follows: 

(a) 

In paragraph 1 the first subparagraph is replaced by the following: 

"For  the  groups  of  materials  and  articles  listed  in  Annex  I  and,  where 
appropriate, combinations of those materials and articles or recycled materials 
and  articles  used  in  the  manufacture  of  those  materials  and  articles,  specific 
measures may be adopted or amended by the Commission." 

(b)  The following subparagraphs are added: 

"The  specific  measures  referred  to  in  point  (m)  shall  be  adopted  by  the 
Commission in accordance with the procedure referred to in Article 23(2). 

The specific measures referred to in points (f), (g), (h), (i), (j), (k), (l) and (n), 
measures designed to amend non-essential elements of this Regulation, shall be 

45 

OJ L 338, 13.11.2004, p. 4. 

EN 

89 

   EN 

                                                 
adopted in accordance with the regulatory procedure with scrutiny referred to 
in Article 23(3). 

The  specific  measures  referred  to  in  points  (a)  to  (e),  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 
23(4)." 

(c)  Paragraph 2 is replaced by the following: 

"2.  The Commission may amend the existing specific directives on materials 
and  articles.  Those  measures,  designed  to  amend  the  non-essential 
elements  of  this  Regulation  by  supplementing  it,  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 23(4)."  

(3) 

Article 11(3) is replaced by the following: 

"Community  authorisation  in  the  form  of  specific  measure,  as  referred  to  in 
paragraph 1, shall be adopted by the Commission. That 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 23(4)." 

(4) 

Article 12(6) is replaced by the following: 

"A  final  specific  measure  on  the  modification,  suspension  or  revocation  of  the 
authorisation shall be adopted by the Commission. That 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 23(4). 
On  imperative  grounds  of  urgency,  the  Commission  may  use  the  urgent  procedure 
referred to in Article 23(5)." 

(5) 

Article 22 is replaced by the following: 

"Article 22 

Amendments  to  Annexes  I  and  II  shall  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 23(3)." 

(6) 

Article 23 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: 

EN 

90 

   EN 

"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 

limits 

laid  down 

time 
in  Article  5a(3)(c),  (4)(b)  and  (4(e)  of 
Decision 1999/468/EC  shall  be  set  at  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. 

ENERGY AND TRANSPORT 

6.1. 

Council Directive 96/98/EC of 20 December 1996 on marine equipment46 

innovative  equipment.  Power  should  also  be  conferred  on 

As  regards  Directive  96/98/EC,  power  should  in  particular  be  conferred  on  the 
Commission  to  adopt  testing  standards  where  international  organisations  fail  or 
refuse to adopt them within a reasonable time, to transfer equipment from Annex A.2 
to Annex A.1, and to authorise, in exceptional circumstances, the placing on board of 
technically 
the 
Commission to apply, for the purposes of the Directive, subsequent amendments of 
international instruments, to update Annex A, to add the possibility of using certain 
modules for equipment listed in Annex A.1, to amend the columns for the conformity 
assessment modules, and to include standardisation organisations in the definition of 
‘testing  standards’  in  Article  2.  Since  those  measures  are  of  general  scope  and  are 
designed  to  amend  non-essential  elements  of  Directive  96/98/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 96/98/EC is amended as follows: 

(1) 

In Article 7, paragraphs 5 and 6 are replaced by the following: 

"5.  Should  the  international  organizations,  including  the  IMO,  fail  or  refuse  to 
adopt  appropriate  testing  standards  for  a  specific  item  of  equipment  within  a 
reasonable time, standards based on the work of the European standardization 
organizations may be adopted. 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 18(3). 

6.  When the testing standards referred to in paragraphs 1 or 5 are adopted or enter 
into force, as appropriate, for a specific item of equipment, that equipment may 
be  transferred  from  Annex  A.2  to  Annex  A.1.  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 18(3). 

46 

OJ L 46, 17.2.1997, p. 25. 

EN 

91 

   EN 

                                                 
Article 5 shall apply to that equipment from the date of that transfer." 

(2) 

In Article 13(2), the first indent is replaced by the following: 

"- the measures are justified, it shall immediately so inform the Member State 
which  took  the  initiative  and  the  other  Member  States;  where  the  decision 
referred to in paragraph 1 is attributed to shortcomings in the testing standards, 
the Commission shall, after consulting the parties concerned, bring the matter 
before  the  Committee  referred  to  in  Article  18(1)  within  two  months  if  the 
Member  State  which  has  taken  the  decision  intends  to  maintain  it  and  shall 
initiate the procedure referred to in Article 18(2)." 

(3) 

In Article 14, paragraph 5 is replaced by the following: 

"5.  Equipment such as is referred to in paragraph 1 shall be added to Annex A.2. 
That measure, 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(3)." 

(4) 

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

"This Directive may be amended in order: 

(a) 

(b) 

(c) 

to  apply  subsequent  amendments  of  international  instruments  for  the 
purposes of this Directive; 

to  update  Annex  A,  both  by  introducing  new  equipment  and  by 
transferring equipment from Annex A.2 to Annex A.1 and vice versa, 

to  add  the  possibility  of  using  modules  B  +  C  and  module  H  for 
equipment  listed  in  Annex  A.1,  and  by  amending  the  columns  for  the 
conformity assessment modules; 

(d) 

to include other standardisation organisations in the definition of ‘testing 
standards’ in Article 2. 

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(3)."  

(5) 

Article 18 is replaced by the following: 

"Article 18 

1. 

The  Commission  shall  be  assisted  by  the  Committee  on  Safe  Seas  and  the 
Prevention of Pollution from Ships (COSS) created 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  laying  down  the  procedures  for  the  exercise  of  implementing 
powers  conferred  on  the  Commission  shall  apply,  having  regard  to  the 
provisions of Article 8 thereof. 

EN 

92 

   EN 

The  period  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be  set  at  two 

months. 

3.  Where reference is made to this paragraph, Article 5(a)(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." 

6.2. 

Regulation (EC) 2099/2002 of the European Parliament and of the Council of 5 
November  2002  establishing  a  Committee  on  Safe  Seas  and  the  Prevention  of 
Pollution from Ships (COSS) and amending the Regulations on maritime safety 
and the prevention of pollution from ships47 

As regards Regulation (EC) 2099/2002, power should in particular be conferred on 
the  Commission  to  amend  Article  2(2)  in  order  to  include  a  reference  to  the 
Community  acts  conferring  implementing  powers  on  COSS  that  have  entered  into 
force following the adoption of this Regulation. Since those measures are of general 
scope  and  are  designed  to  amend  non-essential  elements  of  Regulation  (EC) 
2099/2002, 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) 2099/2002 is amended as follows: 

(1) 

Article 3 is replaced by the following: 

"1.  The  Commission  shall  be  assisted  by  a  Committee  on  Safe  Seas  and  the 

Prevention of Pollution from Ships (hereinafter called COSS). 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
one month.  

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

(2) 

Article 7 is replaced by the following: 

47 

OJ L 324, 29.11.2002, p. 1 

EN 

93 

   EN 

                                                 
"Article 7 

Powers of COSS 

COSS  shall  exercise  the  powers  conferred  on  it  by  virtue  of  the  Community 
legislation  in  force.  Article  2(2)  may  be  amended  by  the  procedure  referred  to  in 
Article  3(3)  in  order  to  include  a  reference  to  the  Community  acts  conferring 
implementing power on COSS that have entered into force following the adoption 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 3(3)". 

6.3. 

Directive 2003/42/EC of the European Parliament and of the Council of 13 June 
2003 on occurrence reporting in civil aviation48 

As  regards  Directive  2003/42/EC,  power  should  in  particular  be  conferred  on  the 
Commission  to  amend  the  Annexes  in  order  to  expand  upon,  or  change,  the 
examples;  to  facilitate  the  exchange  of  information;  and  to  adopt  measures  for  the 
dissemination  to  interested  parties  of  the  information.  Since  those  measures  are  of 
general  scope  and  are  designed  to  amend  non-essential  elements  of  Directive 
2003/42/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. 

Accordingly, Directive 2003/42/EC is amended as follows: 

(1) 

In Article 3, paragraph 2 is replaced by the following: 

"2.  The Commission may decide to amend the Annexes in order to expand upon, 
or  change,  the  examples.  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 10(3)." 

(2) 

In Article 7, paragraph 2 is replaced by the following: 

"2.  Without  prejudice  to  the  public's  right  of  access  to  the  Commission's 
documents  as  laid  down  in  Regulation  (EC)  No  1049/2001  of  the  European 
Parliament  and  the  Council  (*),  the  Commission  shall  adopt  on  its  own 
initiative measures for the dissemination to interested parties of the information 
referred  to  in  paragraph  1  and  the  associated  conditions.  These  measures, 
which can be general or individual, shall be based on the need: 

- 

- 

to  provide  persons  and  organisations  with  the  information  they  need  to 
improve civil aviation safety, 

to  limit the dissemination  of information to  what is  strictly required  for 
the purpose of its users, in order to ensure appropriate confidentiality of 
that information. 

48 

OJ L 167, 4.7.2003, p. 23 

EN 

94 

   EN 

                                                 
The individual measures shall be adopted in accordance with the procedure referred 

to in Article 10(2).  

The  general  measures,  which  are  measures  designed  to  amend  the  non-essential 
elements of this Directive by supplementing it, shall be adopted in accordance 
with the regulatory procedure with scrutiny referred to in Article 10(3). 

The decision to disseminate information under this paragraph shall be limited to what 
is  strictly  required  for  the  purpose  of  its  user,  without  prejudice  to  the 
provisions of Article 8. 

_____________________ 

(*)  OJ L 145, 31.5.20001, p. 43."  

(3) 

Article 10 is replaced by the following: 

"Article 10 

1. 

The Commission shall be assisted by the committee instituted by Article 12 of 
Council Regulation (EEC) No 3922/91. 

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 period provided for in Article 5(6) of Decision 1999/468/EC shall be set at 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." 

6.4. 

Directive 2004/36/EC of the European Parliament and of the Council of 21 April 
2004 on the safety of third-country aircraft using Community airports49 

As  regards  Directive  2004/36/EC,  power  should  in  particular  be  conferred  on  the 
Commission  to  adopt  measures  for  the  dissemination  to  interested  parties  of  the 
information  obtained  through  ramp  inspections  conducted  under  the  European 
Community  (EC)  SAFA  Programme,  and  measures  amending  the  Annexes  to  the 
Directive,  laying  down  the  elements  of  technical  procedures  for  the  conduct  and 
reporting of SAFA ramp inspections. Since those measures are of general scope and 
are  designed  to  amend  non-essential  elements  of  Directive  2004/36/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. 

Accordingly, Directive 2004/36/EC is amended as follows: 

(1) 

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

49 

OJ L 143, 30.4.2004, p. 76. 

EN 

95 

   EN 

                                                 
"3.  Without  prejudice  to  the  public's  right  of  access  to  the  Commission's 
documents  as  laid  down  in  Regulation  (EC)  No  1049/2001,  the  Commission 
shall adopt, on its own initiative, measures for the dissemination to interested 
parties  of  the  information  referred  to  in  paragraph  1  and  the  associated 
conditions. These measures, which may be general or individual, shall be based 
on the need: 

- 

- 

to  provide  persons  and  organisations  with  the  information  they  need  to 
improve civil aviation safety; 

to  limit the dissemination  of information to  what is  strictly required  for 
the purposes of its users, in order to ensure appropriate confidentiality of 
that information. 

The  individual  measures  shall  be  adopted  in  accordance  with  the  procedure 
referred to in Article 10(3).  

The general measures, which are measures designed to amend the non-essential 
elements of this Directive by supplementing it, shall be adopted in accordance 
with the regulatory procedure with scrutiny referred to in Article 10(4)." 

(2) 

Article 10 is replaced by the following: 

"Article 10 

1. 

The  Commission  shall  be  assisted  by  the  committee  set  up  by  Article  12  of 
Regulation (EEC) No 3922/91 (*). 

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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
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 Committee may furthermore be consulted by the Commission on any other 
matter concerning the application of this Directive. 

_________________________________ 

(*) OJ L 373, 31.12.1991, p. 4."  

(3) 

Article 12 is replaced by the following: 

EN 

96 

   EN 

The Commission may amend the Annexes to this Directive. 

"Article 12 

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 10(4)."  

6.5. 

Regulation (EC) No 868/2004 of the European Parliament and of the Council of 
21  April  2004  concerning  protection  against  subsidisation  and  unfair  pricing 
practices causing injury to Community air carriers in the supply of air services 
from countries not members of the European Community50 

As regards Regulation (EC) No 868/2004, power should in particular be conferred on 
the Commission to develop a detailed methodology for determining the existence of 
unfair  pricing  practices.  This  methodology  should  cover,  inter  alia,  the  manner  in 
which normal competitive pricing, actual costs and reasonable profit margins shall be 
assessed  in  the  specific  context  of  the  aviation  sector.  Since  those  measures  are  of 
general scope and are designed to amend non-essential elements of Regulation (EC) 
No  868/2004  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, Regulation (EC) No 868/2004 is amended as follows: 

(1) 

In Article 5, paragraph 3, is replaced by the following: 

"3.  The  Commission  shall  develop  a  detailed  methodology  for  determining  the 
existence of unfair pricing practices. This methodology shall cover, inter alia, 
the  manner  in  which  normal  competitive  pricing,  actual  costs  and  reasonable 
profit  margins  shall  be  assessed  in  the  specific  context  of  the  aviation  sector. 
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 15(3a)." 

(2) 

Article 15 is replaced by the following: 

"Article 15 

Committee procedure 

1. 

The Commission shall be assisted by the Committee instituted by Article 11 of 
Council Regulation (EEC) No 2408/92(*). 

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. 

50 

OJ L 162, 30.4.2004, p. 1 

EN 

97 

   EN 

                                                 
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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
three months. 

3a  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 240, 24.8.1992, p. 8" 

6.6. 

Directive 2004/54/EC of the European Parliament and of the Council of 29 April 
2004 on minimum safety requirements for tunnels in the Trans-European Road 
Network51 

As regards Directive 2004/54/EC, 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 Directive 
2004/54/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 2004/54/EC is amended as follows: 

(1) 

Article 16 is replaced by the following: 

"Article 16  

Adaptation to technical progress 

The  Commission  shall  adapt  to  technical  progress  the  Annexes  to  this  Directive. 
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 17 is replaced by the following: 

"Article 17 

Committee 

1. 

The Commission shall be assisted by a committee. 

51 

OJ L 167, 30.4.2004, p. 39. 

EN 

98 

   EN 

                                                 
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 period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
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." 

6.7. 

Regulation (EC) No 2111/2005 of the European Parliament and of the Council 
of  14  December  2005  on  the  establishment  of  a  Community  list  of  air  carriers 
subject  to  an  operating  ban  within  the  Community  and  on  informing  air 
transport passengers of the identity of the operating air carrier, and repealing 
Article 9 of Directive 2004/36/EC52 

As regards Regulation (EC) No 2111/2005, power should in particular be conferred 
on the Commission to modify the common criteria for imposing an operating ban on 
an air carrier in order to take account of scientific and technical developments. Since 
those  measures  are  of  general  scope  and  are  designed  to  amend  non-essential 
elements of Regulation (EC) No 2111/2005, 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. 

On  grounds  of  efficiency,  the  normal  time  limits  for  the  regulatory  procedure  with 
scrutiny  should  be  curtailed  for  the  modification  of  the  Annex  setting  out  the 
common  criteria  for  consideration  of  an  operating  ban  for  safety  reasons  at 
Community level. 

Accordingly, Regulation (EC) No 2111/2005 is amended as follows: 

(1) 

Article 3(2) is replaced by the following: 

"2.  The  common  criteria  for  imposing  an  operating  ban  on  an  air  carrier,  which 
shall be based on the  relevant safety standards, are set out in the Annex (and 
are  hereinafter  referred  to  as  the  common  criteria).  The  Commission  may 
modify  the  Annex,  in  particular  in  order  to  take  account  of  scientific  and 
technical developments. Those measures, designed to amend the non-essential 
elements of this Regulation, shall be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 15(4)." 

(2) 

Article 15 is replaced by the following: 

"Article 15 

1. 

The Commission shall be assisted by the Committee referred to in Article 12 of 
Regulation (EEC) No 3922/91 (the Committee). 

52 

OJ L 344, 27.12.2005, p. 15. 

EN 

99 

   EN 

                                                 
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 period referred to in Article 5(6) of Decision 1999/468/EC shall be set at 
three months. 

4.  Where reference is made to this paragraph, Article 5(a) (1) to (4) and (5) (b), 
and 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. 

5. 

The  Commission may consult the Committee on any other matter concerning 
the application of this Regulation." 

EN 

100 

   EN 

 
(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

Chronological Index 

Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community 
procedures for contaminants in food – Page 53. 

Council  Directive  93/74/EEC  of  13  September  1993  on  feedingstuffs  intended  for 
particular nutritional purposes – Page 54. 

Council  Regulation  (EC)  No  2494/95  of  23  October  1995  concerning  harmonized 
indices of consumer prices – Page 29. 

Council  Directive  96/23/EC  of  29  April  1996  on  measures  to  monitor  certain 
substances and residues thereof in live animals and products and repealing Directives 
85/358/EEC  and  86/469/EEC  and  Decisions  89/187/EEC  and  91/664/EEC  –  Page 
56. 

Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated 
biphenyls and polychlorinated terphenyls – Page 20. 

Council Directive 96/98/EC of 20 December 1996 on marine equipment – Page 91. 

Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  of  27 
January 1997 concerning novel foods and novel food ingredients – Page 59. 

Directive 97/68/EC of the European Parliament and of the Council of 16 December 
1997  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  measures 
against the emission of gaseous and particulate pollutants from internal combustion 
engines to be installed in non-road mobile machinery – Page 8. 

Council Regulation EC) No 577/98 of 9 March 1998 on the organisation of a labour 
force sample survey in the Community – Page 31. 

Council  Regulation  (EC)  No  1165/98  of  19  May  1998  concerning  short-term 
statistics – Page 33. 

Decision  2119/98/EC  of  the  European  Parliament  and  of  the  Council  of  24 
September  1998  setting  up  a  network  for  the  epidemiological  surveillance  and 
control of communicable diseases in the Community – Page 59. 

Directive  98/79/EC  of  the  European  Parliament  and  of  the  Council  of  27  October 
1998 on in vitro diagnostic medical devices – Page 9. 

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for 
human consumption – Page 21. 

Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 
on  radio  equipment  and  telecommunications  terminal  equipment  and  the  mutual 
recognition of their conformity – Page 12. 

(15) 

Council  Regulation  (EC)  No  530/1999  of  9  March  1999  concerning  structural 
statistics on earnings and on labour costs – Page 40. 

EN 

101 

   EN 

(16) 

(17) 

(18) 

(19) 

(20) 

(21) 

(22) 

(23) 

(24) 

(25) 

(26) 

(27) 

Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 
December 1999 on orphan medicinal products – Page 13. 

Directive  2000/13/EC  of  the  European  Parliament  and  of  the  Council  of  20  March 
2000 on the approximation of the laws of the Member States relating to the labelling, 
presentation and advertising of foodstuffs – Page 61. 

Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 
June 2000 on substances that deplete the ozone layer – Page 22. 

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 
on  the  approximation  of  the  laws,  regulations  and  administrative  provisions  of  the 
Member States relating to the implementation of good clinical practice in the conduct 
of clinical trials on medicinal products for human use – Page 14. 

Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 
on  the  approximation  of  the  laws,  regulations  and  administrative  provisions  of  the 
Member  States  concerning  the  manufacture,  presentation  and  sale  of  tobacco 
products – Page 64. 

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 
2001 on the Community code relating to veterinary medicinal products – Page 16. 

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 
2001 on general product safety – Page 66. 

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 
January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  the  European  Food  Safety  Authority  and  laying  down  procedures  in 
matters of food safety – Page 67. 

Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 
October 2002 laying down health rules concerning animal by-products not intended 
for human consumption – Page 69. 

Regulation  (EC)  2099/2002  of  the  European  Parliament  and  of  the  Council  of  5 
November  2002  establishing  a  Committee  on  Safe  Seas  and  the  Prevention  of 
Pollution from Ships (COSS) and amending the Regulations on maritime safety and 
the prevention of pollution from ships – Page 93. 

Regulation (EC) No 2195/2002 of the European Parliament and of the Council of 5 
November 2002 on the Common Procurement Vocabulary (CPV) – Page 47. 

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 
2003  setting  standards  of  quality  and  safety  for  the  collection,  testing,  processing, 
storage  and  distribution  of  human  blood  and  blood  components  and  amending 
Directive 2001/83/EC – Page 77. 

(28) 

Regulation (EC) No 450/2003 of the European Parliament and of the Council of 27 
February 2003 concerning the labour cost index – Page 41. 

EN 

102 

   EN 

(29) 

(30) 

(31) 

(32) 

(33) 

(34) 

(35) 

(36) 

(37) 

(38) 

(39) 

(40) 

(41) 

(42) 

Directive  2003/42/EC  of  the  European  Parliament  and  of  the  Council  of  13  June 
2003 on occurrence reporting in civil aviation – Page 94. 

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 
September 2003 on additives for use in animal nutrition – Page 79. 

Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 
November 2003 on smoke flavourings used or intended for use in or on foods – Page 
81. 

Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 
November 2003 on the control of salmonella and other specified food-borne zoonotic 
agents – Page 82. 

Directive  2004/17/EC  of  the  European  Parliament  and  of  the  Council  of  31  March 
2004  coordinating  the  procurement  procedures  of  entities  operating  in  the  water, 
energy, transport and postal services sectors – Page 48. 

Directive  2004/18/EC  of  the  European  Parliament  and  of  the  Council  of  31  March 
2004  on  the  coordination  of  procedures  for  the  award  of  public  works  contracts, 
public supply contracts and public service contracts – Page 50. 

Directive  2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31  March 
2004 on setting standards of quality and safety for the donation, procurement, testing, 
processing, preservation, storage and distribution of human tissues and cells – Page 
84. 

Directive  2004/36/EC  of  the  European  Parliament  and  of  the  Council  of  21  April 
2004 on the safety of third-country aircraft using Community airports – Page 96. 

Regulation (EC) No 868/2004 of the European Parliament and of the Council of 21 
April  2004  concerning  protection  against  subsidisation  and  unfair  pricing  practices 
causing injury to Community air carriers in the supply of air services from countries 
not members of the European Community – Page 97. 

Directive  2004/54/EC  of  the  European  Parliament  and  of  the  Council  of  29  April 
2004  on  minimum  safety  requirements  for  tunnels  in  the  Trans-European  Road 
Network – Page 98. 

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 
April  2004  on  official  controls  performed  to  ensure  the  verification  of  compliance 
with feed and food law, animal health and animal welfare rules – Page 87. 

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 
October 2004 on materials and articles intended to come into contact with food and 
repealing Directives 80/590/EEC and 89/109/EEC – Page 89. 

Regulation (EC) No 1552/2005 of the European Parliament and of the Council of 7 
September 2005 on statistics relating to vocational training in enterprises – Page 44. 

Regulation (EC) No 2111/2005 of the European Parliament and of the Council of 14 
December 2005 on the establishment of a Community list of air carriers subject to an 

EN 

103 

   EN 

operating ban within the Community and on informing air transport passengers of the 
identity of the operating air carrier, and repealing Article 9 of Directive 2004/36/EC 
– Page 99. 

Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 
January  2006  concerning  the  establishment  of  a  European  Pollutant  Release  and 
Transfer  Register  and  amending  Council  Directives  91/689/EEC  and  96/61/EC  – 
Page 25. 

Directive 2006/7/EC of the European Parliament and of the Council of 15 February 
2006  concerning  the  management  of  bathing  water  quality  and  repealing  Directive 
76/160/EEC – Page 27. 

Directive  2006/21/EC  of  the  European  Parliament  and  of  the  Council  of  15  March 
2006 on the management of waste from extractive industries and amending Directive 
2004/35/EC – Page 28. 

(43) 

(44) 

(45) 

(46) 

Directive  2006/42/EC  of  the  European  Parliament  and  of  the  Council  of  17  May 
2006 on machinery, and amending Directive 95/16/EC (recast) – Page 18. 

EN 

104 

   EN