EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 19.12.2017  
COM(2017) 795 final  
ANNEX 1  
 
ANNEX  
PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND OF 
THE COUNCIL  
laying down rules and procedures for compliance with and enforcement of Union 
harmonisation legislation on products and amending Regulations (EU) No 305/2011, 
(EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of 
the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 
2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 
2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU 
and 2014/90/EU of the European Parliament and of the Council  
{SWD(2017)  466 final} - {SWD(2017)  467 final} - {SWD(2017)  468 final} - 
{SWD(2017)  469 final} - {SWD(2017)  470 final}    
EN 1  EN ANNEX  
List of  Union harmonisation legislation  
1. Council Directive 69/493/EEC of 15 December 1969 on the approximation of the 
laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 599);  
2. Council Directive 70/157/EEC 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 (OJ L 04 2 , 23.02.1970, p. 16 -20);   
3. 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 –20); 
4. Council Directive 75/324/EEC of 20 May 1975  on the approximation of the laws of 
the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40 –47);   
5. 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 weigh t or by volume of certain 
pre-packaged products (OJ L 46, 21.2.1976, p. 1 –11); 
6. 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 –50); 
7. 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 –28); 
8. Directive 94/11/EC of the European Parliament and of the Co uncil 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 (OJ L 100, 19.4.1994, p. 37 –41); 
9. European Parliament and Council Directive 94/62/EC of 20 December 1994 on 
packaging and packaging waste (OJ L 365, 31.12.1994, p. 10 –23); 
10. Directive 98/70/EC of the European Parliament and of the Council of 13 October 
1998 relating to the quality of petrol  and diesel fuels and amending Council Directive 
93/12/EEC (OJ L 350, 28.12.1998, p. 58 –68); 
11. 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 emissi on 
in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1 –78); 
12. Directive 2000/53/EC of the European Parliament and of the Council of 18 
September 2000 on end -of life vehicles (OJ L 269, 21.10.2000, p. 34 –43); 
13. Regulation (EC) No 2003/200 3 of the European Parliament and of the Council of 13 
October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1 –194);   
14. Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 
February 2004 on drug precursors (OJ L 47, 18.2.2 004, p. 1–10); 
15. Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 
March 2004 on the interoperability of the European Air Traffic Management network 
(the interoperability Regulation) (OJ L 96, 31.3.2004, p. 26 –42); 
16. Regulation (E C) No 648/2004 of the European Parliament and of the Council of 31 
March 2004 on detergents (OJ L 104, 8.4.2004, p. 1 –35);  
EN 2  EN 17. Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 
April 2004 on persistent organic pollutants and amend ing Directive 79/117/EEC (OJ 
L 158, 30.4.2004, p. 7 –49);   
18. Directive 2004/42/CE of the European Parliament and of the Council of 21 April 
2004 on the limitation of emissions of volatile organic compounds due to the use of 
organic solvents in certain paints  and varnishes and vehicle refinishing products and 
amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87 –96); 
19. Directive 2004/52/EC of the European Parliament and of the Council of 29 April 
2004 on the interoperability of electronic road toll systems i n the Community (OJ L 
200, 7.6.2004, p. 50 –57);  
20. 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 Co uncil Directive 70/156/EEC (OJ L 
310, 25.11.2005, p. 10 –27); 
21. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 
2006 on machinery (OJ L 157, 9.6.2006, p. 24 –86); 
22. Directive 2006/40/EC of the European Parliament and of the Council o f 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 –18);  
23. Directive 2006/66/EC of the European Parliament and of the Council of 6 September 
2006 on batter ies and accumulators and waste batteries and accumulators and 
repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1 –14); 
24. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 
December 2006 concerning the Registration, Evaluat ion, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, 
amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 
and Commission Regulation (EC) No 1488/94 as well as Council Directive 
76/769/ EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p.1);  
25. Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 
June 2007 on type approval of motor vehicles with respect to emissio ns from light 
passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle 
repair and maintenance information (OJ L 171, 29.6.2007, p. 1 –16);  
26. Directive 2007/45/EC of the European Parliament and of the Council of 5 September 
2007 laying d own 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 –20); 
27. Directive 2007/46/EC of the European Parliament and of the Council of 5 September 
2007 establishing a framework for the approval of motor vehicles and their trailers, 
and of systems, components and separate technical units intended for such vehicles 
(OJ L 263, 9.10.2007, p. 1 –160);   
28. Directive 2008/2/EC of the European Parliament and of the Council of 15 January 
2008 on the field of vision and windscreen wipers for wheeled agricultural or 
forestry tractors (Codified version) (OJ L 24, 29.1.2008, p. 30 –38);  
EN 3  EN 29. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and 
mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and 
amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1 –1355);  
30. Regulation (EC) No 78/2009 of the European Parliament and of the Council of 14 
January 2009 on the type -approval of motor vehicles with regard to the protection of 
pedestrians and other vulnerable road users , amending Directive 2007/46/EC and 
repealing Directives 2003/102/EC and 2005/66/EC (OJ L 35, 4.2.2009, p. 1 –31);  
31. Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14 
January 2009 on type -approval of hydrogen -powered motor vehicl es, and amending 
Directive 2007/46/EC (OJ L 35, 4.2.2009, p. 32 –46); 
32. Directive 2009/34/EC of the European Parliament and of the Council of 23 April 
2009 relating to common provisions for both measuring instruments and methods of 
metrological control (OJ L 106, 28.4.2009, p. 7 –24);  
33. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 
2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1 –37); 
34. Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 
June 2009 on  type-approval of motor vehicles and engines with respect to emissions 
from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance 
information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC 
and repealing Directives  80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 
18.7.2009, p. 1 –13); 
35. Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 
July 2009 concerning type -approval requirements for the general safety of motor 
vehicles, their trailers  and systems, components and separate technical units intended 
therefor (OJ L 200, 31.7.2009, p. 1 –24);   
36. Directive 2009/125/EC of the European Parliament and of the Council of 21 October 
2009 establishing a framework for the setting of ecodesign requireme nts for energy -
related products (OJ L 285, 31.10.2009, p. 10 –35); 
37. Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 
September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 
1–30); 
38. Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 
November 2009 on the labelling of tyres with respect to fuel efficiency and other 
essential parameters (OJ L 342, 22.12.2009, p. 46 –58);  
39. Regulation (EC) No 1223/2009 of the E uropean Parliament and of the Council of 30 
November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59 –209);  
40. Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 
November 2009 on the EU Ecolabel (OJ L 27, 30.1.2010, p. 1 –19);  
41. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 
2010 on transportable pressure equipment (OJ L 165, 30.6.2010, p. 1 –18); 
42. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 
March 2011 laying down h armonised conditions for the marketing of construction 
products  and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5 –43);  
EN 4  EN 43. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 
on the restriction of the use of cert ain hazardous substances in electrical and 
electronic equipment (OJ L 174, 1.7.2011, p. 88 –110);  
44. Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 
September 2011 on textile fibre names and related labelling and marking of the  fibre 
composition of textile products and repealing Council Directive 73/44/EEC and 
Directives 96/73/EC and 2008/121/EC of the European Parliament and of the 
Council (OJ L 272, 18.10.2011, p. 1 –64); 
45. Regulation (EU) No 528/2012 of the European Parliament a nd of the Council of 22 
May 2012 concerning the making available on the market and use of biocidal 
products (OJ L 167, 27.6.2012, p. 1 –123);  
46. Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 
on waste electrical and electroni c equipment (WEEE) (OJ L 197, 24.7.2012, p. 38 –
71); 
47. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 
February 2013 on the approval and market surveillance of agricultural and forestry 
vehicles (OJ L 60, 2.3.2013, p. 1 –51);  
48. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 
January 2013 on the approval and market surveillance of two - or three -wheel 
vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52 –128);  
49. Directive 2013/29/EU of the European Parliam ent and of the Council of 12 June 
2013 on the harmonisation of the laws of the Member States relating to the making 
available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27 –65); 
50. Directive 2013/53/EU of the European Parliament and of the Council of 20 
November 2013 on recreational craft and personal watercraft and repealing Directive 
94/25/EC (OJ L 354, 28.12.2013, p. 90 –131);  
51. Directive 2014/28/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of th e laws of the Member States relating to the making 
available on the market and supervision of explosives for civil uses (OJ L 96, 
29.3.2014, p. 1 –44);  
52. Directive 2014/29/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisat ion of the laws of the Member States relating to the making 
available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45 –78); 
53. Directive 2014/30/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of th e laws of the Member States relating to 
electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79 –106);  
54. Directive 2014/31/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of the laws of the Member States relating to  the making 
available on the market of non -automatic weighing instruments (OJ L 96, 29.3.2014, 
p. 107–148);  
55. Directive 2014/32/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of the laws of the Member States relati ng to the making 
available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149 –250);   
EN 5  EN 56. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of the laws of the Member States relating to li fts and 
safety components for lifts (OJ L 96, 29.3.2014, p. 251 –308);  
57. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of the laws of the Member States relating to equipment 
and protective systems  intended for use in potentially explosive atmospheres (OJ L 
96, 29.3.2014, p. 309 –356);  
58. Directive 2014/35/EU of the European Parliament and of the Council of 26 February 
2014 on the harmonisation of the laws of the Member States relating to the making 
available on the market of electrical equipment designed for use within certain 
voltage limits (OJ L 96, 29.3.2014, p. 357 –374);  
59. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 
2014 on the harmonisation of the laws of the Memb er States relating to the making 
available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 
153, 22.5.2014, p. 62 –106);  
60. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 
2014 on the harmonisation of the la ws of the Member States relating to the making 
available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164 –259);  
61. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 
on marine equipment and repealing Council Dir ective 96/98/EC (OJ L 257, 
28.8.2014, p. 146 –185);  
62. Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 
April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 
842/2006 (OJ L 150, 20.5.2014, p. 195 –230);  
63. Regu lation (EU) No 540/2014 of the European Parliament and of the Council of 16 
April 2014 on the sound level of motor vehicles and of replacement silencing 
systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC 
(OJ L 158, 27.5.2014, p. 131–195);  
64. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 
2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 
31.3.2016, p. 1 –50); 
65. Regulation (EU) 2016/425 of the European Parliament and of the Counc il of 9 March 
2016 on personal protective equipment and repealing Council Directive 89/686/EEC 
(OJ L 81, 31.3.2016, p. 51 –98);  
66. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 
2016 on appliances burning gaseous fuels and r epealing Directive 2009/142/EC (OJ 
L 81, 31.3.2016, p. 99 –147);  
67. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 
178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 
90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1 –175);  
68. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 
2017 on in vitro diagnostic medical devices and repealing Directive 98/79/ EC and 
Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176 –332);   
EN 6  EN 69. Regulation (EU) 2017/852 of the European Parliament and of the Council on 
mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1 –
21); 
70. Regulation (EU) 2017/1369  of the European Parliament and of the Council of 4 July 
2017 setting a framework for energy labelling and repealing Directive 2010/30/EU 
(OJ L 198, 28.7.2017, p. 1 –23).’