Documente Academic
Documente Profesional
Documente Cultură
-mejora las reglas de vigilancia del mercado para proteger mejor a los consumidores y
profesionales de los productos inseguros, incluidos los importados de fuera de la UE. En
particular, esto se aplica a los procedimientos para los productos que pueden suponer un peligro
para la salud o el medio ambiente;
Supera
1. http://ec.europa.eu/growth/single-market/ce-marking/index_en.htm
2. http://ec.europa.eu/growth/index_en.htm
3. http://www.newapproach.org/Directives/DirectiveList.asp
Directive 2011/65/EU of the European Parliament and of the Council (OJ L 174/88, 1/7/2011) of
8 June 2011 on the restriction of the use of certain hazardous substances in electrical and
electronic equipment (recast). ROHS Directive
Directive 2009/142/EC of the European Parliament and of the Council (OJ L 330 of 16/12/2009)
of 30 November 2009 relating to appliances burning gaseous fuels
Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009
(OJ L 285/10 of 31/10/2009) of 21 October 2009 establishing a framework for the setting of
ecodesign requirements for energy-related products (recast)
Directive 2009/105/EC of the European Parliament and of the Council (OJ L 264 of 8/10/2009) of
16 September 2009 relating to simple pressure vessels
Directive 2009/48/EC of the European Parliament and of the Council (OJ L 170 of 30/6/2009) of
18 June 2009 on the safety of toys
Directive 2006/95/EC of the European Parliament and of the Council (OJ L 374 of 27/12/2006) of
12 December 2006 on the harmonisation of the laws of Member States relating to electrical
equipment designed for use within certain voltage limits. Low Voltage Directive
Directive 2006/42/EC of the European Parliament and of the Council (OJ L 157 of 9/6/2006) of
17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 213 of 7/9/95).
Machinery Directive
Directive 2004/108/EC of the European Parliament and of the Council (OJ L 390 of 31/12/2004)
of 15 Decemerber 2004 on the approximation of the laws of the Member States relating to
electromagnetic compatibility. EMC Directive
Directive 2004/22/EC of the European Parliament and of the Council (OJ L 135 of 30/4/2004) of
31 March 2004 on measuring instruments (amended by Council Directive 2006/96/EC (OJ L 363
of 20/12/2006) and Regulation (EC) No 1137/2008 (OJ L 311 of 21/11/2008)
Directive 2000/9/EC of the European Parliament and of the Council (OJ L 106 of 3/5/2000) of
20 March 2000 relating to cableway installations designed to carry persons
Directive 1999/5/EC (OJ L 91 of 7/4/99) of 9 March 1999 on radio equipment and
telecommunications terminal equipment and the mutual recognition of their conformity
(amended by Regulation (EC) No 1882/2003 (OJ L 284 of 31/10/2003)). RTTE Directive
Directive 98/79/EC of the European Parliament and of the Council (OJ L 331 of 7/12/98) of
27 October 1998 on in vitro diagnostic medical devices (amended by
Regulation (EC) No 1882/2003 (OJ L 284 of 31/10/2003))
Directive 97/23/EC of the European Parliament and of the Council (OJ L 181 of 9/7/1997) of
29 May 1997 on the approximation of the laws of the Member States concerning pressure
equipment (amended by Regulation (EC) No 1882/2003 (OJ L 284 of 31/10/2003))
European Parliament and Council Directive 95/16/EC (OJ L 213 of 7/9/95) of 29 June 1995 on
the approximation of the laws of the Member States relating to lifts (amended by
Regulation (EC) No 1882/2003 (OJ L 284 of 31/10/2003) and Directive 2006/42/EC (OJ L 157 of
9/6/2006))
Directive 94/25/EC of the European Parliament and of the Council (OJ L 164 of 30/6/94) of
16 June 1994 on the approximation of the laws, regulations and administrative provisions of the
Member States relating to recreational craft (amended by Directive 2003/44/EC (OJ L 214 of
26/8/2003), Regulation (EC) No 1882/2003 (OJ L 284 of 31/10/2003) and Regulation (EC)
No 1137/2008 l (OJ L 311 of 21/11/2008))
Directive 94/9/EC of the European Parliament and the Council (OJ L 100 of 19/4/94) 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 (amended by
Regulation (EC) No 1882/2003 (OJ L 284 of 31/10/2003)) ATEX Directive
Council Directive 93/42/EEC (OJ L 169 of 12/7/93) of 14 June 1993 concerning medical
devices (amended by Directive 98/79/EC (OJ L 331 of 7/12/98), Directive 2000/70/EC (OJ L 313
of 13/12/2000), Directive 2001/104/EC (OJ L 6 of 10/01/2002), Directive 2007/47/EC (OJ L 247 of
21/9/2007) and Regulation (EC) No 1882/2003 (OJ L 284 of 31/10/2003))
Council Directive 93/15/EEC (OJ L 121 of 15/5/93) of 5 April 1993 on the harmonization of the
provisions relating to the placing on the market and supervision of explosives for civil uses
(amended by Regulation (EC) 1882/2003 (OJ L 284 of 31/10/2003) and
Regulation (EC) No 219/2009 (OJ L 87 of 31/3/2009))
Council Directive 92/42/EEC (OJ L 167 of 22/6/92) of 21 May 1992 on efficiency requirements
for new hot-water boilers fired with liquid or gaseous fuels (amended by Council
Directive 93/68/EEC (OJ L 220 of 30/8/93), Directive 2004/8/EC (OJ L 52 of
21/02/2004), Directive 2008/28/EC (OJ L 81 of 20/3/2008) and Directive 2009/125/EC
(OJ L 285/10 of 31/10/2009))
Council Directive 90/385/EEC (OJ L 189 of 20/7/90) of 20 June 1990 on the approximation of the
laws of the Member States relating to active implantable medical devices (amended by Council
Directive 93/42/EEC (OJ L 169 of 12/7/93), Council Directive 93/68/EEC (OJ L 220 of 30/8/93),
Directive 2007/47/EC (OJ L 247 of 21/9/2007) and Regulation (EC) No 1882/2003 (OJ L 284 of
31/10/2003))
Council Directive 90/384/EEC (OJ L 189 of 20/7/90) of 20 June 1990 on the harmonization of the
laws of the Member States relating to non-automatic weighing instruments (amended by
Council Directive 93/68/EEC (OJ L 220 of 30/8/93))
Council Directive 89/686/EEC (OJ L 399 of 30/12/89) of 21 December 1989 on the
approximation of the laws of the Member States relating to personal protective equipment
(amended by Council Directive 93/68/EEC (OJ L 220 of 30/8/93), Council Directive 93/95/EEC
(OJ L 276 of 9/11/93) and Directive 96/58/EC of the European Parliament and of the Council
(OJ L 236 of 18/9/96))
Council Directive 89/106/EEC (OJ L 40 of 11/2/89) of 21 December 1988 on the approximation
of laws, regulations and administrative provisions of the Member States relating to construction
products (amended by Council Directive 93/68/EEC (OJ L 220 of 30/8/93) and
Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284 of
31/10/2003))
Directiva 2014/35/UE del Parlamento Europeo y del Consejo, de 26 de febrero de 2014, sobre
la armonizacin de las legislaciones de los Estados miembros en materia de comercializacin de
material elctrico destinado a utilizarse con determinados lmites de tensin. Baja Tensin.
No se trata de nuevas Directivas, sino que se trata por un lado de una modificacin de Directivas
ya existentes y por otro lado, de su adaptacin a la Decisin n 768/2008/CE del Parlamento
Europeo y del Consejo, de 9 de julio de 2008, sobre un marco comn para la comercializacin de
los productos, establece principios comunes y disposiciones de referencia aplicables a toda la
legislacin sectorial con el fin de establecer una base coherente para la revisin o refundicin de
dicha legislacin. Definen claramente
Fabricante,
Representante Autorizado,
Importador,
Distribuidor
y sus obligaciones
With regard to Directive 1999/5/EC (the R&TTE Directive), the RED has introduced the following changes:
(1) sound and TV receive-only equipment, which has been excluded from the R&TTE Directive, now falls within
the scope of the new Directive;
(2) equipment operating below 9 kHz, which has been excluded from the R&TTE Directive, now falls within the
scope of the Directive;
(3) radio-determination equipment (equipment that uses the propagation qualities of radio waves to determine
its position ) is now clearly included within the scope of the Directive;
(4) telecom terminal equipment (Wired telecommunications terminal equipment ) now falls outside the scope of
the new Directive; this equipment will be covered by the LVD/EMC Directive if their scope covers this equipment;
(5) custom built evaluation kits destined for professionals to be used solely at research and development
facilities for such purposes is explicitly excluded from the RED.
Member States shall not impede, for the aspects covered by this Directive (RED 2004/14/UE), the making
available on the market or putting into service of radio equipment covered by this Directive which is in
conformity with the relevant Union harmonisation legislation applicable before 13 June 2016 and which was
placed on the market before 13 June 2017.
It is noted that, since the R&TTED can be applicable during the transitional period, the intention is to keep
valid, during the above transitional period, the references of the harmonised standards for the R&TTE
Directive, as well as the notified bodies notified under the R&TTED.
PRODUCTS WITHIN OLD LVD/EMCD AND CONTINUE TO BE WITHIN NEW LVD/EMCD (EVEN AFTER
APPLICABILITY OF RED)
-Products placed on market before 20 April 2016: old LVD/EMCD
-Products placed on market on or after 20 April 2016: new LVD/EMCD
PRODUCTS WITHIN OLD/NEW LVD/EMCD BUT THEN FALL WITHIN RED (AFTER APPLICABILITY OF
RED)-FOR EXAMPLE TELEVISION AND SOUND BROADCASTING RECEIVERS
-Products placed on market before 20 April 2016: old LVD/EMCD
-Products placed on market between 20 April 2016 and 12 June 2016 : new LVD/EMCD
-Products placed on market between 13 June 2016 and 12 June 2017: RED or new LVD/EMCD
-Products placed on market after 12 June 2017: RED
PRODUCTS WITHIN R&TTED AND THEN OUTSIDE RED-FOR EXAMPLE TERMINAL EQUIPMENT
-Products placed on market before 13 June 2016: R&TTED
-Products placed on market after 12 June 2016: RED is not applicable; new LVD/EMCD, if applicable to the
product in question (for example if the equipment is outside the voltage range specified in LVD, LVD is not
applicable but the General Product Safety Directive could be applicable provided that the equipment is a
consumer product)
5 mm
min.
Documentacin
Tcnica
Anlisis de Directivas
y Manual de
Normas Armonizadas Instrucciones
Declaracin UE
de Conformidad
Marcado CE
Emisin sonora Reciclaje Prod. EE
Equipos
Atmsferas explosivas telecomunicacin
De quin es la responsabilidad?
FABRICANTE.
REPRESENTANTE AUTORIZADO.
IMPORTADORES Y DISTRIBUIDORES.
REPRESENTANTE AUTORIZADO
El fabricante puede designar mediante un mandato por escrito cualquier persona
fsica o jurdica para actuar en su nombre como representante autorizado.
Mientras sean responsables del material, los importadores se asegurarn de que las
condiciones de su almacenamiento o transporte no comprometan el cumplimiento de los
objetivos de seguridad.
Siempre que se considere oportuno con respecto a los riesgos que presente el material,
para proteger la salud y la seguridad de los consumidores, los fabricantes sometern a
ensayo muestras del material comercializado, investigarn y, en su caso, mantendrn un
registro de las reclamaciones, del material no conforme y de las recuperaciones de
material, y mantendrn informados a los distribuidores de todo seguimiento de este tipo.
Durante diez aos despus de la introduccin del material en el mercado, los importadores
mantendrn una copia de la declaracin UE de conformidad a disposicin de las
autoridades de vigilancia del mercado y se asegurarn de que, previa peticin, dichas
autoridades reciban una copia de la documentacin tcnica.
Sobre la base de una solicitud motivada de una autoridad nacional competente, los
importadores facilitarn toda la informacin y documentacin necesarias, en soporte de
papel o formato electrnico, para demostrar la conformidad del material, en una lengua
fcilmente comprensible para dicha autoridad.
se asegurarn de que el material lleve el marcado CE, vaya acompaado de los documentos
exigidos y de las instrucciones y la informacin relativa a la seguridad en una lengua
fcilmente comprensible para los consumidores y otros usuarios finales del Estado miembro
en el que se vaya a comercializar, y de que el fabricante y el importador hayan cumplido los
requisitos establecidos.
DISTRIBUIDOR
Mientras sean responsables de material, los distribuidores se asegurarn de que las
condiciones de su almacenamiento o transporte no comprometan el cumplimiento de los
objetivos de seguridad
MONTADOR E INSTALADOR
EL USUARIO
El artculo 11 del Reglamento indica que los fabricantes, como base para la
declaracin de prestaciones, elaborar una documentacin tcnica en la que se
describan todos los documentos correspondientes relativos al sistema requerido de
evaluacin y verificacin de la constancia de las prestaciones. Esta es una
documentacin nueva que establece el Reglamento y que no exista en la Directiva.
http://www.f2i2.net/legislacionseguridadindustrial/ReglamentoProductosConstruc
cion.aspx
http://ec.europa.eu/enterprise/sectors/construction/index_en.htm