Time

Subject

Acquis references

EC Speaker

16 JAN.

09:00

Opening & Introduction

David Daly (DG Enlargement), Mr. Jacques McMillan (DG Enterprise & Industry)

16 JAN.

09:30 – 12:30

GENERAL PRINCIPLES

Free movement of goods in the non-harmonised area

EC Treaty: in particular Articles 28 to 30, 95(4) to 95(9), 296 to 298 - Case law of the European Court of Justice and Commission interpretative communications

• 31970L0050
  Commission Directive 70/50/EEC of 22 December 1969 based on the provisions of Article 33 (7), on the abolition of measures which have an effect equivalent to quantitative restrictions on imports and are not covered by other provisions adopted in pursuance of the EEC Treaty (O.J. L 013 , 19/01/1970 p.29) html

• Guide to the Concept and Practical Application of Articles 28-30 EC[1] html

09:30 – 09:45

General introduction of EC Treaty articles 28 (imports), 29 (exports) and 30 (exceptions)

 Mr. Maciej Gorka ENTR/C.5

09:45 – 09:55

Time for questions

09:55 – 10:10

Measures having equivalent effect and types of barriers to trade

 Mr. Florian Schmidt ENTR/C.5

10:10 – 10:20

Time for questions

10:20 – 10:35

Exception rule of article 30 and relation between articles 28 and 30

 Ms. Katarzyna Janicka ENTR/C.5

10:35 – 10:45

Time for questions

10:45 - 11:00

Coffee Break

11:00 – 11:15

Elimination of technical barriers to trade and principle of mutual recognition

• 32000Y0519(02)
  Council Resolution of 28 October 1999 on mutual recognition (O.J. C 141 19.05.2000 p. 5) html pdf

• 52003XC1104(01)
  Commission interpretative communication on facilitating the access of products to the markets of other Member States: the practical application of mutual recognition (O.J. C 265, 04/11/2003, p. 2) html pdf

 Ms. Katleen Hendrix ENTR/C.5

11:15 – 11:25

Time for questions

11:25 – 11:40

Decision 3052/95, “strawberry” regulation and any other questions

• 31995D3052
  Decision No 3052/95/EC of the European Parliament and of the Council of 13 December 1995 establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community. (O.J. L 321, 30/12/1995 p. 1) guide html

• 31998R2679
  Council Regulation (EC) No 2679/98 of 7 December 1998 on the functioning of the internal market in relation to the free movement of goods among the Member States (O.J. L 337, 12/12/1998 p.8)  html

• 41998X1212(01)
  Resolution of the Council and of the Representatives of the Governments of the Members States, meeting within the Council, of 7 December 1998 on the free movement of goods (O.J. L337, 12/12/1998, p. 12) html

 Ms. Katleen Hendrix ENTR/C.5

11:40 –12:30

Time for questions

12:30 – 14:00

Lunch Break

16 JAN.

14:00 – 18:00

HORIZONTAL MEASURES[2] [3]

14:00 – 14:30

General principles of the New Approach

• 31985Y0604(01)
  Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (OJ C 136 04.06.1985 p. 1) html

• 31990Y0116(01)
  Council Resolution of 21 December 1989 on a global approach to conformity assessment (OJ C 010 , 16/01/1990 p.1) html

• 32003G1125(02)
  Council Resolution of 10 November 2003 on the Communication of the European Commission "Enhancing the Implementation of the New Approach Directives" (OJ C 282 25.11.2003 p. 3) html pdf

Mr. Jacques McMillan, ENTR/C.1

14:30 – 14:45

Time for questions

14:45 – 15:00

Coffee Break

15:00 – 15:45

Standardisation

• 31998L0034
  (standardisation part only) Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations, as amended
  (OJ L 204 21.07.1998 p. 37) html pdf consolidated version

• 32000Y0519(01)
  Council Resolution of 28 October 1999 on the role of standardisation in Europe (OJ C 141 19.05.2000 p. 1) html pdf

• General guidelines for the co-operation between CEN, CENELEC and ETSI and the European Commission and the European Free Trade Association, adopted and signed on 28 March 2003 (O.J. C 91, 16/04/2003 p. 7) html

• Commission Staff Working Document of 18.10.2004 html  

• Communication COM(2004) 674 of 18.10.2004 from the Commission to the European Parliament and the Council 'The role of European standardisation in the framework of European policies and legislation' html

• Council Conclusions of 21-22 December 2004 on European standardisation (Document 14790/2/04 REV 2) html

• Commission Staff (DG ENTR) - Action Plan for European Standardisation – October 2005 html

Mr. Norbert Anselmann, Mr. Gerhard Leibrock, ENTR/C.2

15:45 -16.00

Time for questions

16:00 – 16:20

Accreditation

• CERTIF Documents html

Mr. Jacques McMillan, Mr. Martin Stadler, ENTR/C.1

16:20 – 16:40

Conformity assessment

• CERTIF Documents html

• 31993D0465
  Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives (OJ L 220 30.08.1993 p. 23) html

Mr. Jacques McMillan, ENTR/C.1

16:40 – 17:00

Market surveillance

• CERTIF Documents html

• 31995Y0722(01)
  Council Resolution of 29 June 1995 on the effective uniform application of Community law and on the penalties applicable for breaches of Community law in the internal market (OJ C 188 22.07.1995 p. 1) html

Mr. Jacques McMillan, Ms. Rita l’Abbate, ENTR/C.1

17:00 –18:00

Time for questions

17 JAN. 09:00 – 18 JAN. 14:30

NEW AND GLOBAL APPROACH PRODUCT LEGISLATION[4]

09:15 –09:35

Recreational craft

• 31994L0025
  Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft, as amended (OJ L 164 30.06.1994 p. 15) html

Mr. Johan Renders, ENTR/H.1

09:35 – 09:45

Time for questions

09:45 – 10:05

Radio and telecommunications terminal equipment (R&TTE)

• 31999L0005
  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, as amended (OJ L91 of 07/04/1999, p.1) html

Mr. Marinus Bogers, Mr. Jean Piquemal, ENTR/H.5

10:05 – 10:15

Time for questions

10:15 – 10:35

Electromagnetic compatibility (EMC)

• 32004L0108
  Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (OJ L 390 31.12.2004 p. 24) html pdf

Mr. Marinus Bogers, Mr. Jean Piquemal, ENTR/H.5

10:35 – 10:45

Time for questions

10:45 –11:00

Coffee Break

11:00 – 11:20

Low Voltage Equipment
(LVD) [5]

• 31973L0023
  Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits, as amended (OJ L 077 26.03.1973 p. 29) html

Mr. Corrado Mattiuzzo, ENTR/H.5

11:20 – 11:30

Time for questions

11:30 – 11:50

Pressure vessels and pressure equipment

• 31975L0324
  Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers, as amended
  (OJ L 147 09.06.1975 p. 40) html [6]

• 31976L0767
  Council Directive 76/767/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to common provisions for pressure vessels and methods for inspecting them, as amended (OJ L 262 27.09.1976 p. 153) html

• 31984L0525
  Council Directive 84/525/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to seamless, steel gas cylinders (OJ L 300 19.11.1984 p. 1) html

• 31984L0526
  Council Directive 84/526/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to seamless, unalloyed aluminium and aluminium alloy gas cylinders (OJ L 300 19.11.1984 p. 20) html

• 31984L0527
  Council Directive 84/527/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to welded unalloyed steel gas cylinders (OJ L 300 19.11.1984 p. 48) html

• 31987L0404
  Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of the Member States relating to simple pressure vessels, as amended (OJ L 220 of 08/08/1987) html

• 31997L0023
  Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment, as amended (OJ L 181 of 09/07/97) html

Mr. Nikolaus Steininger, ENTR/H.6

11:50 – 12:00

Time for questions

12:00 – 12:20

Toys

• 31988L0378
  Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys, as amended
  (OJ L 187 16.07.1988 p. 1) html
  Amendment proposed by 51999PC0577

Ms. Elina Pietiläinen, ENTR/I.4

12:20 – 12:30

Time for questions

12:30 – 14:00

Lunch Break

17 JAN.

14.00 –14:20

Eco-design requirements for energy-using products (EUP)

• 32005L0032
  Directive 2005/32/EC of the European Parliament and of the Council of 6 July 2005 establishing a framework for the setting of ecodesign requirements for energy-using products and amending Council Directive 92/42/EEC and Directives 96/57/EC and 2000/55/EC of the European Parliament and of the Council (O.J. L 191, 22/07/2005, p. 29) html

Mr. Michail Papadoyannakis, ENTR/H.5

14:20 – 14:30

Time for questions

14:30 – 15:30

Machinery, noise emissions by outdoors equipment, emissions of pollutants from non-road mobile machinery engines

• 31998L0037
  Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery, as amended (OJ L 207 23.07.1998 p. 1) html
  Amendment proposed by 52000PC0899

• 32000L0014
  Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162 03.07.2000 p. 1) html pdf

• 31997L0068
  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 (O.J. L 059 , 27/02/1998 p.1) html

Mr. Martin Eifel, ENTR/H.5

Mr. David Eardley, ENTR/H.5

Mr. Michail Papadoyannakis, ENTR/H.5

15:30 – 15:50

Time for questions

15:50 – 16:05

Coffee break

16:05 – 16:25

ATEX

• 31994L0009
  Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres, as amended (OJ L 100 19.04.1994 p. 1) html

Mr. Corrado Mattiuzzo, ENTR/H.5

16:25 – 16:35

Time for questions

16:35 - 16:55

Personal Protective Equipment (PPE)

• 31989L0686
  Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment, as amended(OJ L 399 30.12.1989 p. 18) html

Mr. Elöd Dudas, ENTR/H.5

16:55– 17:15

Lifts

• 31995L0016
  European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts, as amended (OJ L 213 07.09.1995 p. 1) html

• Amendment proposed by 52000PC0899

Mr. Ian Fraser, ENTR/H.5

17:15 – 17:30

Time for questions

17:30 – 17:50

Cableway installations

• 32000L0009
  Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2000 relating to cableway installations designed to carry persons (OJ L 106 03/05/2000) html

Ms. Belén-Niceas Martínez Arriola, ENTR/H.1

17:50 – 17800

Time for questions

18 JAN.

09:00 – 09:40

Construction products

• 31989L0106
  Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products, as amended (OJ L 040 11.02.1989 p. 12) html

Mr. Nicke Blomquist, ENTR/G.3

09:40– 10:00

Time for questions

10:00 – 10:20

Gas appliances

• 31990L0396
  Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels, as amended (OJ L 196 26.07.1990 p. 15) html

Mr. Cornelis Brekelmans, ENTR/H.6

10:20– 10:30

Time for questions

10:30 – 10:45

Coffee Break

10:45 – 11:30

Legal metrology

• 31990L0384
  Council Directive 90/384/EEC of 20 June 1990 on the harmonization of the laws of the Member States relating to non-automatic weighing instruments, as amended (OJ L 189 20.07.1990 p. 1) html

• 32004L0022
  Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments (OJ L 135 30.04.2004 p. 1) html pdf

•  Old Approach metrology directives: see Eur-Lex Directory: 13.30.12 Metrology ; DG ENTR Pink Book: 5.1.

Mr. Cornelis Brekelmans, ENTR/H.6

11:30 – 11:40

Time for questions

11:40 – 12:00

Pre-packaging[7]

• 31975L0106
  Council Directive 75/106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids, as amended
  (OJ L 042 15.02.1975 p. 1) html
  Amendment proposed by 52004PC0708

• 31975L0107
  Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (O.J. L 042 , 15/02/1975 p.14) html

• 31976L0211
  Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products, as amended
  (OJ L 046 21.02.1976 p. 1) html
  Amendment proposed by 52004PC0708

• 31980L0232
  Council Directive 80/232/EEC of 15 January 1980 on the approximation of the laws of the Member States relating to the ranges of nominal quantities and nominal capacities permitted for certain prepackaged products, as amended (OJ L 051 25.02.1980 p. 1) html Amendment proposed by 52004PC0708

Mr. Cornelis Brekelmans, ENTR/H.6

12:00 – 12:10

Time for questions

12:10 – 13:40

Lunch Break

18 JAN.

13:40 – 14:20

Medical devices [8]

• 31984L0539
  Council Directive 84/539/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine [9] (O.J. L 300 , 19/11/1984 p.179) html

• 31990L0385
  Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended (OJ L 189 20.07.1990 p. 17) html

• 31993L0042
  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended (OJ L 169 12.07.1993 p. 1) html

• 32003L0012 Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (O.J. L 028, 04/02/2003, p. 43) html pdf

• 31998L0079
  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as amended (OJ L 331 of 07/12/98) html

Ms. Susanne Höke, ENTR/F.3

14:20 – 14:30

Time for questions

18 JAN. 14:30 – 20 JAN. 13:00

OLD APPROACH PRODUCT LEGISLATION

14:30 – 15:30

Pharmaceuticals 1/2

Community codes relating to medicinal products for human and veterinary use [10]; Regulation relating to the centralised procedure

• Eur-Lex Directory: 13.30.15 Proprietary medicinal products ; DG ENTR Pink Book: 3.

Mr. Erik Helstad, ENTR/F.2

15:30 - 15:50

Time for questions

15:50 -16:05

Coffee Break

16:05 -17:05

Pharmaceuticals 2/2

Good clinical practice; orphan medicinal products; good manufacturing practice; colouring matters

Transparency in relation to pricing and reimbursement of medicinal products

• Pharmaceuticals acquis

Mr. Erik Helstad, ENTR/F.2

Mr. Christophe Roeland, ENTR/F.5

17:05 - 18:00

Time for questions

19 JAN.

09:00 – 09:35

Cosmetics

• 31976L0768
  Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, as amended (OJ L 262 27.09.1976 p. 169) html Consolidated text 01976L0768-20050913

Ms. Barbara Mentré, ENTR/F.3

09:35 – 09:45

Time for questions

09:45 – 10:00

Coffee Break

10:00 – 10:30

Chemicals 1/2

limitations regulation

GHS

REACH

• 31976L0769
  Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations, as amended (OJ L 262 27.09.1976 p. 201)  html
  Amendment proposed by 52004PC0320
  Amendment proposed by 52004PC0638

• 31999L0045
  Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, as amended (OJ L 200 30.07.1999 p. 1) html pdf Consolidated text 01999L0045-20040501
  Amendment proposed by 52003PC0644(01)
  Amendment proposed by 52004PC0148(01)

Ms. Fulvia Raffaelli, Ms. Uta Jensen-Korte, ENTR/G.1

10:30 – 11:00

Time for questions

11:00 – 12:30

Chemicals 2/2[11]

Civil Explosives

Detergents

Fertilisers

GLP

• 31993L0015
  Council Directive 93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses, as amended (OJ L 121 15.05.1993 p. 20) [12] html

• 32004R0648
  Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (Text with EEA relevance) (OJ L 104 08.04.2004 p. 1) html pdf

• 32003R2003
  Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers, as amended (OJ L 304 21.11.2003 p. 1) html pdf - Consolidated text: 02003R2003-20041224

• 32004L0010
  Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (O.J. L 050 , 20/02/2004 p.44) html pdf

• 32004L0009
  Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (O.J. L050 , 20/02/2004 p.28) html pdf

• 32004R0273
  Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (O.J. L 047 , 18/02/2004 p.1) html

Mr. Maik Schmahl, ENTR/G.2

Mr. Stéphane Brion, ENTR/G.2

Mr. Stephen Pickering and Mr. Philippe Brunerie, ENTR/G.2

Mr. Maik Schmahl, ENTR/G.2

tbd

ENTR/G.2

12:30 - 13:00

Time for questions

13.00 – 14.30

Lunch Break

19 JAN.

14:45 – 16:00

Motor vehicles

• Eur-Lex Directory: 13.30.10 Motor vehicles ; DG ENTR Pink Book: 1.2.1 & 1.2.2 & 1.3.

• Eur-Lex Directory: 13.30.11 Agricultural and forestry tractors ; DG ENTR Pink Book: 1.2.3.

Ms. Agnieszka Kozakiewicz, ENTR/F.1

16:00 – 16:15

Coffee Break

16:15 – 16:45

Time for questions

16:45 – 16:55

Textile

• Eur-Lex Directory: 13.30.17 Textiles  ; DG ENTR Pink Book: 8.2.10

Mr. Constantin Livas, ENTR/I.4

16:55 – 17:05

Footwear

• 31994L0011
  Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer, as amended (OJ L 100 19.04.1994 p. 37) html

Ms. Outi Niiranen, ENTR/I.4

17:05 - 17:15

Time for questions

17:15 – 17:25

Wood classification

• 31968L0089
  Council Directive 68/89/EEC of 23 January 1968 on the approximation of the laws of the Member States concerning the classification of wood in the rough (OJ L 032 06.02.1968 p. 12) html

Mr. Joan Antoni Salmurri Trinxet, ENTR/I.3

17:25 – 17:35

Crystal glass

• 31969L0493
  Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass, as amended (OJ L 326 29.12.1969 p. 36) html

Mr. Kevin Bream, ENTR/I.2

17:35 – 17:45

Time for questions

20 JAN.

09:00 – 13:00

PROCEDURAL MEASURES

09:00 – 10:15

Notification procedures

• 31998L0034
  Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations, as amended
  (OJ L 204 21.07.1998 p. 37) html pdf consolidated version

Mr. Christos Kyriatzis, ENTR/C.3

10:15 – 10:35

Time for questions

10:35 – 10:50

External border checks

• 31993R0339
  Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries, as amended (OJ L 040 17.02.1993 p. 1) html

Ms. Doris Gradenegger, ENTR/C.1

10:50 – 11:05

Time for questions

11:05 – 11:20

Coffee Break

11:20 – 11:40

Firearms

• 31991L0477
  Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons (OJ L 256 13.09.1991 p. 51) html

Tbd

ENTR/C.4

11:40 – 12:00

Cultural goods

Background

• 31992R3911
  Council Regulation (EEC) No 3911/92 of 9 December 1992 on the export of cultural goods, as amended (O.J. L 395 , 31/12/1992 p.1) html

• 31993L0007
  Council Directive 93/7/EEC of 15 March 1993 on the return of cultural objects unlawfully removed from the territory of a Member State, as amended (O.J. L 074, 27/03/1993 p.74) html

Ms. Angela Casasnovas Sese, ENTR/C.4

12:00 – 12:20

Time for questions

12.20 – 13.00

Closing questions & remarks

Mr. Jacques McMillan (DG Enterprise and Industry), Mr. David Daly (DG Enlargement)