DECISION
No 2/2008
of 16 May 2008
of the Committee updating the legal references in the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to conformity assessment
(2009/455/EC)
ANNEX
‘ANNEX 1
PRODUCT SECTORS
CHAPTER 1
MACHINERY
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
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 (OJ L 207, 23.7.1998, p. 1), as last amended by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 (OJ L 331, 7.12.1998, p. 1). |
Switzerland |
100. |
Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). |
101. |
Ordinance of 12 June 1995 on the safety of technical installations and equipment (RO 1995 2770), as last amended on 27 March 2002 (RO 2002 853). |
|
102. |
Ordinance of 12 June 1995 on the procedures of conformity assessment of technical installations and equipment (RO 1995 2783). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Second-hand machinery
CHAPTER 2
PERSONAL PROTECTIVE EQUIPMENT
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
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 last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). |
Switzerland |
100. |
Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). |
101. |
Ordinance of 12 June 1995 on the safety of technical installations and equipment (RO 1995 2770), as last amended on 27 March 2002 (RO 2002 853). |
|
102. |
Ordinance of 12 June 1995 on the procedures of conformity assessment of technical installations and equipment (RO 1995 2783). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
CHAPTER 3
TOYS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys (OJ L 187, 16.7.1988, p. 1) and corrected by corrigenda (OJ L 281, 14.10.1988, p. 55 and OJ L 37, 9.2.1991, p. 42), as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). |
Switzerland |
100. |
Federal Law of 9 October 1992 on foodstuffs and commodities (RO 1995 1469) as last amended on 21 March 2003 (RO 2003 4803). |
101. |
Ordinance of 23 November 2005 on foodstuffs and commodities (RO 2005 5451) as last amended on 15 November 2006 (RO 2006 4909). |
|
102. |
Ordinance of EDI of 27 March 2002 on the safety of toys (RO 2002 1082) as last amended on 15 November 2006 (RO 2006 5157). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information concerning the certificate and the technical file
2.
Notification of grounds for refusal by approved bodies
CHAPTER 4
MEDICAL DEVICES
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
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 last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). |
2. |
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). |
|
3. |
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) and corrected by corrigenda (OJ L 22, 29.1.1999, p. 75 and OJ L 6, 10.1.2002, p. 70). |
|
4. |
Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices (OJ L 131, 16.5.2002, p. 17). |
|
5. |
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 (OJ L 28, 4.2.2003, p. 43). |
|
6. |
Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18) and corrected by corrigendum (OJ L 6, 8.1.2005, p. 10). |
|
7. |
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41). |
|
8. |
Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation (OJ L 379, 28.12.2006, p. 98). |
|
9. |
Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L 247, 21.9.2007, p. 21). |
|
Switzerland |
100. |
Federal Law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 20 December 2006 (RO 2006 5599). |
101. |
Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 et RS 4 798), as last amended on 17 June 2005 (RO 2006 2197). |
|
102. |
Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2005 (RO 2006 2197). |
|
103. |
Federal law of 22 March 1991 on radiation protection (RO 1994 1933), as last amended on 21 March 2003 (RO 2004 4719). |
|
104. |
Ordinance of 17 October 2001 on medical devices (RO 2001 3487), as last amended on 18 May 2005 (RO 2005 2695). |
|
105. |
Ordinance of 18 April 2007 on import, transit and export of animals and animal products (RO 2007 1847). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Registration of the person responsible for placing devices on the market
2.
Labelling of medical devices
3.
Information exchange
4.
European databank
CHAPTER 5
GAS APPLIANCES AND BOILERS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(1)
European Community |
1. |
Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17), as subsequently amended. |
Switzerland |
100. |
Ordinance of 16 December 1985 on Air Pollution Control (OAPC) (Annex 3 and 4) (RS 814.318.142.1), as subsequently amended. |
Provisions covered by Article 1(2)
European Community |
2. |
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 last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). |
Switzerland |
101. |
Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). |
102. |
Ordinance of 12 June 1995 on the safety of technical installations and equipment (RO 1995 2770), as last amended on 27 March 2002 (RO 2002 853). |
|
103. |
Ordinance of 12 June 1995 on the procedures of conformity assessment of technical installations and equipment (RO 1995 2783). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
CHAPTER 6
PRESSURE VESSELS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(1)
European Community |
1. |
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), as subsequently amended. |
|||
2. |
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), as subsequently amended. |
||||
3. |
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), as subsequently amended. |
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4. |
Council Directive 1999/36/EC of 29 April 1999 on transportable pressure equipment (OJ L 138, 1.6.1999, p. 20), as last amended by Commission Directive 2001/2/EC of 4 January 2001 (OJ L 005, 10.1.2001, p. 4), as subsequently amended. |
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Switzerland |
100. |
No legislation relating to Directives 84/525/EEC, 84/526/EEC and 84/527/EEC. |
|||
101. |
Relating to Directive 1999/36/EC:
|
Provisions covered by Article 1(2)
European Community |
5. |
Council Directive 87/404/EEC of 25 June 1987 on the approximation of the laws of the Member States relating to simple pressure vessels (OJ L 220, 8.8.1987, p. 48), as last amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). |
6. |
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 (OJ L 181, 9.7.1997, p. 1), as last amended by Regulation No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). |
|
Switzerland |
102. |
Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). |
103. |
Ordinance of 20 November 2002 on the safety of simple pressure vessels (RO 2003 107). |
|
104 |
Ordinance of 20 November 2002 on the safety of pressure equipment (RO 2003 38). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Recognition of certificates and conformity marks
2.
Technical documentation
CHAPTER 7
RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
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 last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). |
2. |
Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p. 13). |
|
3. |
Commission Decision 2000/637/EC of 22 September 2000 on the application of Article 3(3)(e) of Directive 1999/5/EC to radio equipment covered by the regional arrangement concerning radiotelephone service on inland waterways (OJ L 269, 21.10.2000, p. 50). |
|
4. |
Commission Decision 2000/638/EC of 22 September 2000 on the application of Article 3(3)(e) of Directive 1999/5/EC to marine radio communication equipment intended to be fitted to seagoing non-SOLAS vessels and which is intended to participate in the global maritime distress and safety system (GMDSS) and not covered by Council Directive 96/98/EC on marine equipment (OJ L 269, 21.10.2000, p. 52). |
|
5. |
Commission Decision 2001/148/EC of 21 February 2001 on the application of Article 3(3)(e) of Directive 1999/5/EC to avalanche beacons (OJ L 55, 24.2.2001, p. 65). |
|
6. |
Commission Decision 2004/71/EC of 4 September 2003 on essential requirements relating to marine radio communication equipment which is intended to be used on non-SOLAS vessels and to participate in the Global Maritime Distress and Safety System (GMDSS) (OJ L 16, 23.1.2004, p. 54). |
|
7. |
Commission Decision 2005/53/EC of 25 January 2005 on the application of Article 3(3)(e) of Directive 1999/5/EC of the European Parliament and of the Council to radio equipment intended to participate in the Automatic Identification System (AIS) (OJ L 22, 26.1.2005, p. 14). |
|
8. |
Commission Decision 2005/631/EC of 29 August 2005 concerning essential requirements as referred to in Directive 1999/5/EC of the European Parliament and of the Council ensuring access of Cospas-Sarsat locator beacons to emergency services (OJ L 225, 31.8.2005, p. 28). |
|
Switzerland |
100. |
Federal Law of 30 April 1997 on Telecommunications (LTC); (RO 1997 2187), as last amended on 24 March 2006 (RO 2007 737 and 921). |
101. |
Ordinance of 14 June 2002 on Telecommunications Equipment; (RO 2002 2086) as last amended on 16 April 2008 (RO 2008 1903). |
|
102. |
Ordinance of 14 June 2002 of the Federal Office of Communications on Telecommunications Equipment (RO 2002 2111), as last amended on 17 September 2007 (RO 2007 4427). |
|
103. |
Annex 1 to the Federal Office of Communications Ordinance on Telecommunications Equipment (RO 2002 2111), as last amended on 21 November 2005 (RO 2005 5139). |
|
104. |
List of technical standards published in the Feuille Fédérale with titles and references, as last amended on 9 October 2007 (FF 2007 6431). |
|
105. |
Ordinance of 9 March 2007 on Telecommunication Services (RO 2007 945). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
TCAM
2.
Market surveillance
3.
Regulated interfaces
4.
Interfaces offered by public telecommunications network operators
5.
Application of essential requirements
6.
Authorisation to disconnect
7.
Harmonised standards
8.
Mutual notification concerning radio communication equipment which conforms to requirements but is not intended for use in the spectrum of one of the parties
9.
Safeguard clause relating to industrial products
CHAPTER 8
EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
Directive 94/9/EC of the European Parliament and of 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 last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) and corrected by corrigenda (OJ L 21, 26.1.2000, p. 42 and OJ L 304, 5.12.2000, p. 19). |
Switzerland |
100. |
Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 and RS 4 798), as last amended on 17 June 2005 (RO 2006 2197). |
101. |
Ordinance on of 2 March 1998 on the safety of equipment and protective systems intended for use in potentially explosive atmospheres (RO 1998 963), as last amended on 2 February 2000 (RO 2002 763). |
|
102. |
Federal Law of 19 March 1976 on the safety of technical installations and equipment (RO 1977 2370), as last amended on 18 June 1993 (RO 1995 2766). |
|
103. |
Ordinance of 12 June 1995 on the safety of technical installations and equipment (RO 1995 2770), as last amended on 27 March 2002 (RO 2002 853). |
|
104. |
Ordinance of 12 June 1995 on the procedures of conformity assessment of technical installations and equipment (RO 1995 2783). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Technical documentation
CHAPTER 9
ELECTRICAL EQUIPMENT AND ELECTROMAGNETIC COMPATIBILITY
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the approximation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits (codified version) (OJ L 374, 27.12.2006, p. 10). |
2. |
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). |
|
Switzerland |
100. |
Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 and RS 4 798), as last amended on 17 June 2005 (RO 2006 2197). |
101. |
Ordinance of 30 March 1994 on electrical weak current installations (RO 1994 1185), as last amended on 2 February 2000 (RO 2000 734). |
|
102. |
Ordinance of 30 March 1994 on electrical heavy current installations (RO 1994 1199), as last amended on 8 December 1997 (RO 1998 54). |
|
103. |
Ordinance of 9 April 1997 on electrical low voltage equipment (RO 1997 1016), as last amended on 2 February 2000 (RO 2000 734 and 764). |
|
104. |
Ordinance of 9 April 1997 on electromagnetic compatibility (RO 1997 1008), as last amended on 4 December 2000 (RO 2000 3012). |
|
105. |
Ordinance of 14 June 2002 on Telecommunications Equipment; (RO 2002 2086) as last amended on 9 March 2007 (RO 2007 995). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Technical documentation
2.
Indication of the name and address of the manufacturer
3.
Standardisation bodies
4.
Notified bodies
5.
Safeguard clause
CHAPTER 10
CONSTRUCTION PLANT AND EQUIPMENT
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
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, 3.7.2000, p. 1), as amended by Directive 2005/88/EC of the European Parliament and of the Council of 14 December 2005 (OJ L 344, 27.12.2005, p. 44) and corrected by corrigendum (OJ L 165, 17.6.2006, p. 35). |
Switzerland |
100. |
Ordinance of 22 May 2007 on the noise emission in the environment by equipment for use outdoors (RO 2007 2827). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Location of the manufacturer
2.
Information exchange
3.
Collection of noise data
CHAPTER 11
MEASURING INSTRUMENTS AND PRE-PACKAGES
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(1)
European Community |
1. |
Council Directive 71/347/EEC of 12 October 1971 on the approximation of the laws of the Member States relating to the measuring of the standard mass per storage volume of grain (OJ L 239, 25.10.1971, p. 1), as subsequently amended. |
2. |
Council Directive 71/349/EEC of 12 October 1971 on the approximation of the laws of the Member States relating to the calibration of the tanks of vessels (OJ L 239, 25.10.1971, p. 15), as subsequently amended. |
|
3. |
Council Directive 76/765/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to alcoholmeters and alcohol hydrometers (OJ L 262, 27.9.1976, p. 143), as subsequently amended. |
|
4. |
Council Directive 86/217/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to tyre pressure gauges for motor vehicles (OJ L 152, 6.6.1986, p. 48), as subsequently amended. |
|
5. |
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 pre-packaged liquids (OJ L 42, 15.2.1975, p. 1), as subsequently amended. |
|
6. |
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 (OJ L 42, 15.2.1975, p. 14), as subsequently amended. |
|
7. |
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 pre-packaged products (OJ L 46, 21.2.1976, p. 1), as subsequently amended. |
|
8. |
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 pre-packaged products (OJ L 51, 25.2.1980, p. 1), as subsequently amended. |
|
9. |
Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17) applicable as from 11 April 2009. |
|
Switzerland |
100. |
Ordinance of 8 June 1998 concerning the measurement and declaration of quantities of goods in trade (RS 941.281), as subsequently amended. |
101. |
Ordinance of 12 June 1998 on technical provisions concerning the declaration of quantities on industrial pre-packages (RS 941.281.1), as subsequently amended. |
Provisions covered by Article 1(2)
|
10. |
Council Directive 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological control, as last amended by Commission Directive 2007/13/EC of 7 March 2007 (OJ L 73, 13.3.2007, p. 10). |
11. |
Council Directive 71/317/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to 5 to 50 kilogramme medium accuracy rectangular bar weights and 1 to 10 kilogramme medium accuracy cylindrical weights (OJ L 202, 6.9.1971, p. 14). |
|
12. |
Council Directive 74/148/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to weights of from 1 mg to 50 kg of above-medium accuracy (OJ L 84, 28.3.1974, p. 3). |
|
13. |
Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40) as last amended by Directive 1999/103/EC of the European Parliament and of the Council of 24 January 2000 (OJ L 34, 9.2.2000, p. 17). |
|
14. |
Council Directive 76/766/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to alcohol tables (OJ L 262, 27.9.1976, p. 149). |
|
15. |
Council Directive 90/384/EEC of 20 June 1990 on the harmonisation of the laws of the Member States relating to non-automatic weighing instruments (OJ L 189, 20.7.1990, p. 1), as amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p. 1). |
|
16. |
European Parliament and Council Directive 2004/2022 of 31 March 2004 on measuring instruments (2004/22/EC) (OJ L 135, 30.4.2004, p. 1). |
|
Switzerland |
102. |
Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2005 (RO 2006 2197). |
103. |
Ordinance of 23 November 1994 on units of measurement (RO 1994 3109). |
|
104. |
Ordinance of 15 February 2006 concerning measuring instruments (RO 2006 1453). |
|
105. |
Ordinance of the Federal Ministry of Justice and Police of 16 April 2004 on non-automatic weighing instruments (RO 2004 2093). |
|
106. |
Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments of length (RO 2006 1433). |
|
107. |
Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measure of volume (RO 2006 1525). |
|
108. |
Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring systems for liquids other than water (RO 2006 1533). |
|
109. |
Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on automatic weighing instruments (RO 2006 1545). |
|
110. |
Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on instruments for thermal energy (RO 2006 1569). |
|
111. |
Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments for gas quantities (RO 2006 1591). |
|
112. |
Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments for exhaust gases of combustion engines (RO 2006 1599). |
|
113. |
Ordinance of the Federal Ministry of Justice and Police of 19 March 2006 on measuring instruments for the electrical energy and power (RO 2006 1613). |
|
114. |
Ordinance of 15 August 1986 on weights (RO 1986 2022), as last amended on 21 November 1995 (RO 1995 5646). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Pre-packages
3.
Marking
4.
Measuring instruments covered by Directive 2004/22/EC
4.1.
Information exchange, market surveillance and administrative cooperation
4.2.
Technical documentation and declaration of conformity
CHAPTER 12
MOTOR VEHICLES
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
Council Directive of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (70/156/EEC), as last amended by Commission Directive Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
2. |
Council Directive of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (70/157/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
3. |
Council Directive of 20 March 1970 on the approximation of the laws of the Member States relating to measures to be taken against air pollution by gases from positive-ignition engines of motor vehicles (70/220/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
4. |
Council Directive of 20 March 1970 on the approximation of the laws of the Member States relating to liquid fuel tanks and rear protective devices for motor vehicles and their trailers (70/221/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
5. |
Council Directive of 20 March 1970 on the approximation of the laws of the Member States relating to the space for mounting and the fixing of rear registration plates on motor vehicles and their trailers (70/222/EEC) (OJ L 76, 6.4.1970, p. 25) as last adjusted by Council Decision of 25 April 2005 (OJ L 157, 21.6.2005, p. 9). |
|
6. |
Council Directive of 8 June 1970 on the approximation of the laws of the Member States relating to the steering equipment for motor vehicles and their trailers (70/311/EEC), as last amended by Commission Directive 1999/7/EC of 26 January 1999 (OJ L 40, 13.2.1999, p. 36). |
|
7. |
Council Directive of 27 July 1970 on the approximation of the laws of the Member States relating to the doors of motor vehicles and their trailers (70/387/EEC) as last amended by Commission Directive 2001/31/EC of 8 May 2001 (OJ L 130, 12.5.2001, p. 33). |
|
8. |
Council Directive of 27 July 1970 on the approximation of the laws of the Member States relating to audible warning devices for motor vehicles (70/388/EEC) as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
9. |
Council Directive of 1 March 1971 on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles (71/127/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
10. |
Council Directive of 26 July 1971 on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and of their trailers (71/320/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
11. |
Council Directive of 20 June 1972 on the approximation of the laws of the Member States relating to the suppression of radio interference produced by spark-ignition engines fitted to motor vehicles (72/245/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
12. |
Council Directive of 2 August 1972 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in vehicles (72/306/EEC), as last amended by Commission Directive 2005/21/EC of 7 March 2005 (OJ L 61, 8.3.2005, p. 25). |
|
13. |
Council Directive of 17 December 1973 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (interior parts of the passenger compartment other than the interior rear-view mirrors, layout of controls, the roof or sliding roof, the backrest and rear part of the seats) (74/60/EEC), as last amended by Directive 2000/4/EC of the European Parliament and of the Council of 28 February 2000 (OJ L 87, 8.4.2000, p. 22). |
|
14. |
Council Directive of 17 December 1973 on the approximation of the laws of the Member States relating to devices to prevent the unauthorised use of motor vehicles (74/61/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
15. |
Council Directive of 4 June 1974 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (the behaviour of the steering mechanism in the event of an impact) (74/297/EEC), as last amended by Commission Directive 91/662/EEC of 6 December 1991 (OJ L 366, 31.12.1991, p. 1) and corrigendum (OJ L 172, 27.6.1992, p. 86). |
|
16. |
Council Directive of 22 July 1974 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (strength of seats and of their anchorages) (74/408/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
17. |
Council Directive of 17 September 1974 on the approximation of the laws of the Member States relating to the external projections of motor vehicles (74/483/EEC), as last amended by Commission Directive 2007/15/EC of 14 March 2007 (OJ L 75, 15.3.2007, p. 21). |
|
18. |
Council Directive of 26 June 1975 on the approximation of the laws of the Member States relating to the reverse and speedometer equipment of motor vehicles (75/443/EEC), as last amended by Commission Directive 97/39/EC of 24 June 1997 (OJ L 177, 5.7.1997, p. 15). |
|
19. |
Council Directive of 18 December 1975 on the approximation of the laws of the Member States relating to statutory plates and inscriptions for motor vehicles and their trailers, and their location and method of attachment (76/114/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
20. |
Council Directive of 18 December 1975 on the approximation of the laws of the Member States relating to anchorages for motor vehicle safety belts (76/115/EEC), as last amended by Directive 2005/41/EC of the European Parliament and of the Council of 7 September 2005 (OJ L 255, 30.9.2005, p. 149). |
|
21. |
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to the installation of lighting and light signalling devices on motor vehicles and their trailers (76/756/EEC), as last amended by Commission Directive 2007/35/EC of 18 June 2007 (OJ L 157, 19.6.2007, p. 14). |
|
22. |
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to reflex reflectors for motor vehicles and their trailers (76/757/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
23. |
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps for motor vehicles and their trailers (76/758/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
24. |
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to direction indicator lamps for motor vehicles and their trailers (76/759/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
25. |
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to the rear registration plate lamps for motor vehicles and their trailers (76/760/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
26. |
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to motor vehicle headlamps which function as main-beam and/or dipped-beam headlamps and to incandescent electric filament lamps for such headlamps (76/761/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
27. |
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to front fog lamps for motor vehicles and filament lamps for such lamps (76/762/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
28. |
Council Directive of 17 May 1977 on the approximation of the laws of the Member States relating to motor vehicle towing devices (77/389/EEC), as last amended by Commission Directive 96/64/EC of 2 October 1996 (OJ L 258, 11.10.1996, p. 26). |
|
29. |
Council Directive of 28 June 1977 on the approximation of the laws of the Member States relating to rear fog lamps for motor vehicles and their trailers (77/538/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
30. |
Council Directive of 28 June 1977 on the approximation of the laws of the Member States relating to reversing lamps for motor vehicles and their trailers (77/539/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
31. |
Council Directive of 28 June 1977 on the approximation of the laws of the Member States relating to parking lamps for motor vehicles (77/540/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
32. |
Council Directive of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (77/541/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
33. |
Council Directive of 27 September 1977 on the approximation of the laws of the Member States relating to the field of vision of motor vehicle drivers (77/649/EEC), as last amended by Commission Directive 90/630/EEC of 30 October 1990 (OJ L 341, 6.12.1990, p. 20). |
|
34. |
Council Directive of 21 December 1977 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (identification of controls, tell-tales and indicators) (78/316/EEC), as last amended by Commission Directive 94/53/EC of 15 November 1994 (OJ L 299, 22.11.1994, p. 26). |
|
35. |
Council Directive of 21 December 1977 on the approximation of the laws of the Member States relating to the defrosting and demisting systems of glazed surfaces of motor vehicles (78/317/EEC) (OJ L 81, 28.3.1978, p. 27), and corrigendum (OJ L 194, 19.7.1978, p. 30). |
|
36. |
Council Directive of 21 December 1977 on the approximation of the laws of the Member States relating to the wiper and washer systems of motor vehicles (78/318/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
37. |
Council Directive of 12 June 1978 on the approximation of the laws of the Member States relating to the wheel guards of motor vehicles (78/549/EEC), as last amended by Commission Directive 94/78/EC of 21 December 1994 (OJ L 354, 31.12.1994, p. 10) and corrigendum (OJ L 153, 4.7.1995, p. 35). |
|
38. |
Council Directive of 16 October 1978 on the approximation of the laws of the Member States relating to head restraints of seats of motor vehicles (78/932/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
39. |
Council Directive of 16 December 1980 on the approximation of the laws of the Member States relating to the fuel consumption of motor vehicles (80/1268/EEC), as last amended by Directive 2004/3/EC of the Council and of the European Parliament of 11 February 2004 (OJ L 49, 19.2.2004, p. 36). |
|
40. |
Council Directive of 16 December 1980 on the approximation of the laws of the Member States relating to the engine power of motor vehicles (80/1269/EEC), as last amended by Commission Directive 99/99/EC of 15 December 1999 (OJ L 334, 28.12.1999, p. 32). |
|
41. |
Council Directive of 3 December 1987 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous pollutants from diesel engines for use in vehicles (88/77/EEC), as last amended by Directive 2005/55/EC of the European Parliament and of the Council (OJ L 275, 20.10.2005, p. 1). |
|
42. |
Council Directive of 13 April 1989 on the approximation of the laws of the Member States relating to the lateral protection (side guards) of certain motor vehicles and their trailers (89/297/EEC) (OJ L 124, 5.5.1989, p. 1). |
|
43. |
Council Directive of 27 March 1991 on the approximation of the laws of the Member States relating to the spray-suppression systems of certain categories of motor vehicles and their trailers (91/226/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
44. |
Council Directive of 31 March 1992 on the masses and dimensions of motor vehicles of category M1 (92/21/EEC), as last amended by Commission Directive 95/48/EC of 20 September 1995 (OJ L 233, 30.9.1995, p. 73) and corrigenda (OJ L 252, 20.10.1995, p. 27 and OJ L 304, 16.12.1995, p. 60). |
|
45. |
Council Directive of 31 March 1992 on safety glazing and glazing materials on motor vehicles and their trailers (92/22/EEC), as last amended by Commission Directive 2001/92/EC of 30 October 2001 (OJ L 291, 8.11.2001, p. 24). |
|
46. |
Council Directive of 31 March 1992 relating to tyres for motor vehicles and their trailers and to their fitting (92/23/EEC), as last amended by Directive 2005/11/EC of 16 February 2005 (OJ L 46, 17.2.2005, p. 42). |
|
47. |
Council Directive of 31 March 1992 relating to speed limitation devices or similar speed limitation on-board systems of certain categories of motor vehicles Directive (92/24/EEC) (OJ L 129, 14.5.1992, p. 154), as last amended by Directive 2004/11/EC of the European Parliament and of the Council of 11 February 2004 (OJ L 44, 14.2.2004, p. 19). |
|
48. |
Council Directive of 17 December 1992 relating to the external projections forward of the cab’s rear panel of motor vehicles of category N (92/114/EEC) (OJ L 409, 31.12.1992, p. 17). |
|
49. |
Directive of the European Parliament and of the Council of 30 May 1994 relating to the mechanical coupling devices of motor vehicles and their trailers and their attachment to those vehicles (94/20/EC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
50. |
Directive of the European Parliament and of the Council of 24 October 1995 relating to the burning behaviour of materials used in the interior construction of certain categories of motor vehicle (95/28/EC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
51. |
Directive 96/27/EC of the European Parliament and of the Council of 20 May 1996 on the protection of occupants of motor vehicles in the event of a side impact and amending Directive 70/156/EEC (OJ L 169, 8.7.1996, p. 1) and corrigendum (OJ L 102, 19.4.1997, p. 46). |
|
52. |
Directive 96/79/EC of the European Parliament and of the Council of 16 December 1996 on the protection of occupants of motor vehicles in the event of a frontal impact and amending Directive 70/156/EEC, as last amended by Commission Directive 1999/98/EC of 15 December 1999, (OJ L 9, 13.1.2000, p. 14). |
|
53. |
Directive 97/27/EC of the European Parliament and of the Council of 22 July 1997 relating to the masses and dimensions of certain categories of motor vehicles and their trailers and amending Directive 70/156/EEC, as last amended by Directive 2003/19/EC of 21 March 2003 (OJ L 79, 26.3.2003, p. 6). |
|
54. |
Directive 98/91/EC of the European Parliament and of the Council of 14 December 1998 relating to motor vehicles and their trailers intended for the transport of dangerous goods by road and amending Directive 70/156/EEC relating to the type approval of motor vehicles and their trailers (OJ L 11, 16.1.1999, p. 25). |
|
55. |
Directive 2000/40/EC of the European Parliament and of the Council of 26 June 2000 on the approximation of the laws of the Member States relating to the front underrun protection of motor vehicles and amending Council Directive 70/156/EEC), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
56. |
Directive 2001/56/EC of the European Parliament and of the Council of 27 September 2001 relating to heating systems for motor vehicles and their trailers, amending Council Directive 70/156/EEC and repealing Council Directive 78/548/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
57. |
Directive 2001/85/EC of the European Parliament and of the Council of 20 November 2001 relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver’s seat, and amending Directives 70/156/EEC and 97/27/EC, and as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
58. |
Directive 2003/97/EC of the European Parliament and of the Council of 10 November 2003 on the approximation of the laws of the Member States relating to the type-approval of devices for indirect vision and of vehicles equipped with these devices, amending Directive 70/156/EEC and repealing Directive 71/127/EEC, and as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
59. |
Directive 2003/102/EC of the European Parliament and of the Council of 17 November 2003 relating to the protection of pedestrians and other vulnerable road users before and in the event of a collision with a motor vehicle and amending Council Directive 70/156/EEC, completed by Commission Decision 2004/90/EC of 23 December 2003 (OJ L 31, 4.2.2004, p. 21) and corrigendum (OJ L 25, 1.2.2007, p. 12). |
|
60. |
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). |
|
61. |
Directive 2005/55/EC of the European Parliament and of the Council of 28 September 2005 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive-ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles, as last amended by Commission Directive 2006/81/EC of 23 October 2006 (OJ L 362, 20.12.2006, p. 92). |
|
62. |
Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10). |
|
63. |
Directive 2005/66/EC of the European Parliament and of the Council of 26 October 2005 relating to the use of frontal protection systems on motor vehicles and amending Council Directive 70/156/EEC (OJ L 309, 25.11.2005, p. 37). |
|
64. |
Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12). |
|
Switzerland |
100. |
Ordinance of 19 June 1995 relating to the technical requirements for power-driven transportation vehicles and their trailers (RO 1995 4145), as last amended on 28 March 2007 (RO 2007 2177). |
101. |
Ordinance of 19 June 1995 relating to the type approval of road vehicles (RO 1995 3997), as last amended on 29 November 2006 (RO 2007 95). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Recognition of vehicle type-approval
3.
Vehicle type-approval safeguard clauses
Registration and entry into service
Measures related to the conformity of production
Nonconformity with the approved type
CHAPTER 13
AGRICULTURAL OR FORESTRY TRACTORS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
Council Directive 74/151/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to certain parts and characteristics of wheeled agricultural or forestry tractors, as last amended by Commission Directive 2006/26/EC of 2 March 2006 (OJ L 65, 7.3.2006, p. 22). |
2. |
Council Directive 74/152/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the maximum design speed of and load platforms for wheeled agricultural or forestry tractors, as last amended by Commission Directive 98/89/EC of 20 November 1998 (OJ L 322, 1.12.1998, p. 40). |
|
3. |
Council Directive 74/346/EEC of 25 June 1974 on the approximation of the laws of the Member States relating to rear-view mirrors for wheeled agricultural or forestry tractors, as last amended by Commission Directive 98/40/EC of 8 June 1998, (OJ L 171, 17.6.1998, p. 28) and corrigendum (OJ L 351, 29.12.1998, p. 42). |
|
4. |
Council Directive 74/347/EEC of 25 June 1974 on the approximation of the laws of the Member States relating to the field of vision and windscreen wipers for wheeled agricultural or forestry tractors, as last amended by Directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277, 10.10.1997, p. 24). |
|
5. |
Council Directive 75/321/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to the steering equipment of wheeled agricultural or forestry tractors, as last amended by Commission Directive 98/39/EC of 5 June 1998 (OJ L 170, 16.6.1998, p. 15). |
|
6. |
Council Directive 75/322/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to the suppression of radio interference produced by spark-ignition engines fitted to wheeled agricultural or forestry tractors, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
7. |
Council Directive 76/432/EEC of 6 April 1976 on the approximation of the laws of the Member States relating to the braking devices of wheeled agricultural or forestry tractors, as last amended by Directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277, 10.10.1997, p. 24). |
|
8. |
Council Directive 76/763/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to passenger seats for wheeled agricultural or forestry tractors, as last amended by Directive 99/86/EC of the Council of 11 November 1999 (OJ L 297, 18.11.1999, p. 22) and corrigendum (OJ L 87, 8.4.2000, p. 34). |
|
9. |
Council Directive 77/311/EEC of 29 March 1977 on the approximation of the laws of the Member States relating to the driver-perceived noise level of wheeled agricultural or forestry tractors, as last amended by Commission Directive 2006/26/EC of 2 March 2006 (OJ L 65, 7.3.2006, p. 22). |
|
10. |
Council Directive 77/536/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to the rollover protection structures of wheeled agricultural or forestry tractors, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
11. |
Council Directive 77/537/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in wheeled agricultural or forestry tractors, as last amended by Directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277, 10.10.1997, p. 24). |
|
12. |
Council Directive 78/764/EEC of 25 July 1978 on the approximation of the laws of the Member States relating to the driver’s seat on wheeled agricultural or forestry tractors, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
13. |
Council Directive 78/933/EEC of 17 October 1978 on the approximation of the laws of the Member States relating to the installation of lighting and light-signalling devices on wheeled agricultural and forestry tractors, as last amended by Commission Directive 2006/26/EC of 2 March 2006 (OJ L 65, 7.3.2006, p. 22). |
|
14. |
Council Directive 79/532/EEC of 17 May 1979 on the approximation of the laws of the Member States relating to the component type-approval of lighting and light-signalling devices on wheeled agricultural or forestry tractors, as last amended by Directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277, 10.10.1997, p. 24). |
|
15. |
Council Directive 79/533/EEC of 17 May 1979 on the approximation of the laws of the Member States relating to the coupling device and the reverse of wheeled agricultural or forestry tractors, as last amended by Commission Directive 1999/58/EC of 7 June 1999 (OJ L 148, 15.6.1999, p. 37). |
|
16. |
Council Directive 79/622/EEC of 25 June 1979 on the approximation of the laws of the Member States relating to the rollover protection structures of wheeled agricultural or forestry tractors (static testing), as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
17. |
Council Directive 80/720/EEC of 24 June 1980 on the approximation of the laws of the Member States relating to the operating space, access to the driving position and the doors and windows of wheeled agricultural or forestry tractors, as last amended by Directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277, 10.10.1997, p. 24). |
|
18. |
Council Directive 86/297/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to the power take-offs of wheeled agricultural and forestry tractors and their protection, as last amended by Directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277, 10.10.1997, p. 24). |
|
19. |
Council Directive 86/298/EEC of 26 May 1986 on rear-mounted rollover protection structures of narrow-track wheeled agricultural and forestry tractors, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
20. |
Council Directive 86/415/EEC of 24 July 1986 on the installation, location, operation and identification of the controls of wheeled agricultural or forestry tractors, as last amended by Directive 97/54/EC of the European Parliament and of the Council of 23 September 1997 (OJ L 277, 10.10.1997, p. 24). |
|
21. |
Council Directive 87/402/EEC of 25 June 1987 on rollover protection structures mounted in front of the driver’s seat on narrow-track wheeled agricultural and forestry tractors, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
22. |
Council Directive 89/173/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to certain components and characteristics of wheeled agricultural or forestry tractors, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
23. |
Directive 2000/25/EC of the European Parliament and of the Council of 22 May 2000 on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors and amending Council Directive 74/150/EEC as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
24. |
Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC, as last amended by Council Directive 2006/96/EC of 20 November 2006 (OJ L 363, 20.12.2006, p. 81). |
|
Switzerland |
100. |
Ordinance of 19 June 1995 relating to the technical requirements for agricultural tractors (RO 1995 4171), as last amended on 28 March 2007 (RO 2007 2181). |
101. |
Ordinance of 19 June 1995 relating to the type approval of road vehicles (RO 1995 3997), as last amended on 29 November 2006 (RO 2007 95). |
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special rules relating to the designation of conformity assessment bodies
Section V
Supplementary provisions
1.
Information exchange
2.
Recognition of vehicle type-approval
3.
Vehicle type-approval safeguard clauses
Registration and entry into service
Measures related to the conformity of production
Nonconformity with the approved type
CHAPTER 14
GOOD LABORATORY PRACTICE (GLP)
Scope and coverage
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(1)
European Community |
Feed additives
Foodstuffs
|
||||||
Switzerland |
No GLP-relevant legislation. |
Provisions covered by Article 1(2)
European Community |
New and existing chemicals
Medicinal products
Veterinary Drugs
Plant Protection Products
Biocides
|
||||||||||||||
Switzerland |
|
Section II
Conformity assessment bodies
Section III
Designating authorities
Section IV
Special principles for designating conformity assessment bodies
European Community |
1. |
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 (OJ L 50, 20.2.2004, p. 44). |
2. |
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) (OJ L 50, 20.2.2004, p. 28). |
|
Switzerland |
100. |
Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122) as last amended on 16 December 2005 (RO 2006 2677). |
101. |
Federal law of 15 December 2000 on protection against dangerous substances and preparations (RO 2004 4763) as last amended on 17 June 2005 (RO 2006 2197). |
|
102. |
Federal law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790) as last amended on 20 December 2006 (RO 2006 5599). |
|
103. |
Ordinance of 18 May 2005 on Good Laboratory Practice (RO 2005 2795). |
Section V
Supplementary provisions
1.
Information exchange
2.
Test facility inspections
3.
Confidentiality
4.
Cooperation
CHAPTER 15
MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION
Scope and coverage
Certification of manufacturers
Batch certification
Official batch release
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
1. |
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). |
2. |
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as last amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 34). |
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3. |
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 (OJ L 33, 8.2.2003, p. 30). |
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4. |
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 (OJ L 311, 28.11.2001, p. 1) as last amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58). |
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5. |
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22). |
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6. |
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70). |
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7. |
Guidelines on Good Distribution Practice of medicinal products for human use (OJ C 63, 1.3.1994, p. 4) (published on website of the European Commission). |
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8. |
EudraLex Volume 4 — Medicinal Products for Human and Veterinary Use: EU Guidelines to Good Manufacturing Practice (published on website of the European Commission). |
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9. |
Directive 2001/20/EC of 04 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 (OJ L 121, 1.5.2001, p. 34). |
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10. |
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13). |
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Switzerland |
100. |
Federal law of December 15, 2000 on medicinal products and medical devices (RO 2001 2790) as last amended on 20 December 2006 (RO 2007 14 11). |
101. |
Ordinance of October 17, 2001 on authorisations in the field of medicines (RO 2001 3399) as last amended on 16 March 2006 (RO 2007 1961). |
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102. |
Ordinance of the Swiss Agency for Therapeutic Products of November 9, 2001 on the requirements for the marketing authorisation of medicinal products (RO 2001 3437) as last amended on 22 June 2006 (RO 2006 3587). |
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103. |
Ordinance of October 17, 2001 on clinical trials of pharmaceutical products (RO 2001 3511) as last amended on 16 March 2007 (RO 2007 1961). |
Section II
Conformity assessment bodies
Section III
Supplementary provisions
1.
Transmission of inspection reports
2.
Inspection reports
3.
GMP Reference
4.
Nature of inspections
5.
Fees
6.
Safeguard clause for inspections
7.
Exchange of information between authorities and approximation of quality requirements
8.
Inspectors training
9.
Joint Inspections
10.
Alert system
11.
Contact points
12.
Divergence of views
CHAPTER 16
CONSTRUCTION PRODUCTS
Section I
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Community |
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Switzerland |
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