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Perfil – Máquinas para el envasado de productos alimenticios en Francia 2008 Sección Económica y Comercial – Embajada Argentina en Francia

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Septiembre de 2008

A) Posición arancelaria y derechos de aduana

P.A. Descripción Terceros Países

SPG*

84 REACTORES NUCLEARES, CALDERAS, MÁQUINAS, APARATOS Y ARTEFACTOS MECÁNICOS, PARTES DE ESTAS MÁQUINAS O APARATOS

8422 Máquinas para lavar vajilla; máquinas y aparatos para limpiar o secar botellas o demás recipientes; máquinas y aparatos para llenar, cerrar, tapar, taponar o etiquetar botellas, botes o latas, cajas, sacos (bolsas) o demás continentes; máquinas y aparatos de capsular botellas, tarros, tubos y continentes análogos; las demás máquinas y aparatos para empaquetar o envolver mercancías, incluidas las de envolver con película termorretráctil; máquinas y aparatos para gasear bebidas

8422 40 - Las demás máquinas y aparatos para empaquetar o envolver mercancías, incluidas las de envolver con película termorretráctil

1,7%

0%

*SPG: Sistema Generalizado de Preferencias. Argentina beneficia de este sistema.

B) Otros impuestos IVA: 19,6%

C) Otros requisitos

- Control sanitario de artículos en contacto con productos alimenticios La inserción en el mercado europeo de artículos destinados a estar en contacto con productos alimenticios debe conformarse con los requisitos impuestos por la UE a fin de garantizar un nivel elevado de protección para la sanidad de los seres humanos y el interés de los consumidores. Para obtener más informaciones se sugiere leer el documento adjunto (anexo 1) o visitar la página Internet: http://exporthelp.europa.eu/thdapp/taxes/show2Files.jsp?dir=/requirements&reporterId1=EU&file1=ehir_eu08_02v002/eu/main/req_hearticl_eu_010_0612.htm&reporterLabel1=EU&reporterId2=FR&file2=ehir_fr08_02v002/fr/main/req_hearticl_fr_010_0612.htm&reporterLabel2=France&label=Health+control+of+articles+in+contact+with+food+products&languageId=fr&status=PROD

PERFIL DE MERCADO: MAQUINAS PARA EL ENVASADO DE PRODUCTOS ALIMENTICIOS


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- Normas de comercialización de equipos eléctricos y electrónicos o Los equipos eléctricos y electrónicos (EEE) insertados en el mercado después del 1 de julio

de 2006 no deben contener plomo, mercurio, cadmio, cromo hexavalent, polibromobifenilos (PBB) y polibromodifenil éteres (PBDEs) en una cantidad superior a la tasa autorizada: 0,01% del peso para el cadmio, 0,1% del peso para las otras sustancias.

o Los fabricantes e importadores son responsables de los desechos de los equipos eléctricos y

electrónicos: el diseño y la producción de los EEE debe facilitar la reutilización y el reciclaje de los

aparatos, los EEE introducidos en el mercado deben ser marcados con el símbolo que indica una

colecta separada de los demás residuos, los importadores deben organizar un sistema individual o colectivo para la colecta, el

tratamiento y la reutilización de los desechos de los equipos eléctricos y electrónicos, cuando los importadores insertan EEE en el mercado, deben pagar una fianza (caution)

para garantizar el financiamiento de la colecta, del tratamiento y de la reutilización de los desechos que resultan de su producción,

los importadores tienen que proporcionar informaciones a los consumidores y a las centrales de tratamiento de los desechos acerca de la reutilización y del tratamiento para los nuevos EEE, en un plazo de un año a partir de su inserción en el mercado,

los importadores tienen que registrarse ante las autoridades competentes y tener datos sobre las obligaciones con respecto a las cantidades y las categorías de los EEE introducidos en el mercado y de los niveles de reciclaje conseguidos.

Para obtener más informaciones se sugiere leer el documento adjunto (anexo 2) o visitar la página Internet: http://exporthelp.europa.eu/thdapp/taxes/show2Files.jsp?dir=/requirements&reporterId1=EU&file1=ehir_eu08_02v002/eu/main/req_spweee_eu_010_0612.htm&reporterLabel1=EU&reporterId2=FR&file2=ehir_fr08_02v002/fr/main/req_spweee_fr_010_0612.htm&reporterLabel2=Francia&label=Marketing+requirements+for+electrical+and+electronic+equipments&languageId=es&status=PROD

- Normas técnicas relativas a la compatibilidad electromagnética Para poder ser introducidos en el mercado de la Unión Europea, los aparatos eléctricos y electrónicos deben cumplir con las principales exigencias establecidas a fin de garantizar que la capacidad de los aparatos es protegida de las perturbaciones electromagnéticas. Los aparatos no deben provocar perturbaciones electromagnéticas superiores al nivel a partir del cual los equipos de radio y de telecomunicaciones no pueden funcionar normalmente. Deben también tener el nivel adecuado de inmunidad frente a las perturbaciones electromagnéticas, que les permiten funcionar sin perturbar de manera inaceptable su propia utilización. Para certificar que los productos cumplen con esos requisitos esenciales se requiere un proceso de evaluación de conformidad. Los aparatos eléctricos y electrónicos que cumplen con esos requisitos esenciales deben llevar la sigla CE de conformidad, antes de ser ingresados en el mercado europeo. Para obtener más informaciones, se sugiere leer el documento adjunto (anexo 3) o visitar la página Internet: http://exporthelp.europa.eu/thdapp/taxes/show2Files.jsp?dir=/requirements&reporterId1=EU&file1=ehir_eu08_02v002/eu/main/req_stdemagn_eu_010_0612.htm&reporterLabel1=EU&reporterId2=FR&file2=ehir_fr08_02v002/fr/main/req_stdemagn_fr_010_0612.htm&reporterLabel2=Francia&label=Technical+standards+for+electromagnetic+compatibility&languageId=es&status=PROD


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- Normas técnicas para los aparatos eléctricos de baja tensión

La introducción en el mercado de la Unión Europea de aparatos eléctricos de baja tensión debe cumplir con requisitos esenciales a fin de proteger a las personas y a los animales de los riesgos provenientes del uso de los aparatos eléctricos, incluyendo no sólo los riesgos eléctricos sino también los riesgos mecánicos, químicos u otros. Antes de poner en el mercado cualquier aparato eléctrico de baja tensión, el fabricante tiene que asegurar y declarar la conformidad del equipo eléctrico. El fabricante tiene también que marcar en el producto el símbolo CE que indica la conformidad del equipo y tiene que redactar una declaración de conformidad. Para obtener más informaciones, se sugiere leer el documento adjunto (anexo 4) o visitar la página Internet: http://exporthelp.europa.eu/thdapp/taxes/show2Files.jsp?dir=/requirements&reporterId1=EU&file1=ehir_eu08_02v002/eu/main/req_stdlovol_eu_010_0612.htm&reporterLabel1=EU&reporterId2=FR&file2=ehir_fr08_02v002/fr/main/req_stdlovol_fr_010_0612.htm&reporterLabel2=Francia&label=Technical+standards+for+low+voltage+electrical+equipment&languageId=es&status=PROD

- Normas técnicas para las máquinas y los componentes de seguridad Para ser introducidos en el mercado de la UE, las máquinas y los componentes de seguridad deben cumplir con normas específicas a fin de garantizar la seguridad de las personas que las utilizan. Estos requisitos imponen reglas para el diseño de las máquinas que debe facilitar su utilización, las instrucciones de utilización, la ergonomía, el control de los sistemas, su mantenimiento, etcétera. Existen dos tipos de trámites para el proceso de puesta en conformidad según el nivel del riesgo. Para las máquinas con un riego menor, es el fabricante quien debe asegurar la conformidad de sus productos. En lo que concierne a las máquinas con un factor de riesgo más elevado, necesitan la intervención de una tercera organización. Los componentes de seguridad no tienen que ser marcados individualmente con la sigla CE, pero tienen que estar acompañados de una declaración de conformidad. En cuanto a las máquinas, deben ser marcadas con la sigla CE y estar acompañadas de una declaración de conformidad. Para obtener más informaciones, se sugiere leer el documento adjunto (anexo 5) o visitar la página Internet: http://exporthelp.europa.eu/thdapp/taxes/show2Files.jsp?dir=/requirements&reporterId1=EU&file1=ehir_eu08_02v002/eu/main/req_stdmachi_eu_010_0612.htm&reporterLabel1=EU&reporterId2=FR&file2=ehir_fr08_02v002/fr/main/req_stdmachi_fr_010_0612.htm&reporterLabel2=Francia&label=Technical+standards+for+machinery+and+safety+components&languageId=es&status=PROD


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D) Estadísticas de las importaciones francesas de máquinas y aparatos para empaquetar o envolver mercancías

País Importación valor (1000€) Participación

2007 País Importación volumen (1000Kg) Participación 2007

2005 2006 2007 2005 2006 2007 Italia 74 154,44 84 213,27 88 108,49 34,94% Italia 2 805,10 3 188,10 3 389,40 39,18% Alemania 58 206,58 69 428,11 76 973,79 30,53% Alemania 1 631,10 1 945,80 1 606,60 18,57% España 14 161,29 18 604,28 19 024,26 7,54% Países Bajos 243,00 335,00 597,60 6,91% Países Bajos 6 885,60 7 360,46 15 158,15 6,01% España 582,30 500,70 531,30 6,14% Suiza 17 979,44 15 750,52 13 795,28 5,47% Bélgica 317,90 194,10 417,90 4,83% Japón 3 581,32 4 197,40 6 842,87 2,71% Hungría 414,40 449,90 285,50 3,3% Bélgica 5 413,07 3 748,14 5 929,08 2,35% San Marino 241,80 249,20 276,60 3,2% Suecia 2 960,64 2 161,06 3 968,24 1,57% Suiza 332,00 294,30 256,00 2,96% San Marino 2 644,74 2 782,69 3 324,82 1,32% Irlanda 157,10 131,10 246,20 2,85% Hungría 3 508,83 3 521,02 3 235,53 1,28% Taiwán 110,70 276,40 222,80 2,58% Finlandia 1 682,62 1 082,24 3 213,32 1,27% Japón 92,70 110,70 163,40 1,89% Reino Unido 3 863,32 2 234,56 2 417,21 0,96% Finlandia 57,20 46,80 83,50 0,97% EE.UU. 3 754,59 5 264,26 1 980,32 0,79% Dinamarca 69,30 116,50 82,00 0,95% Dinamarca 1 422,02 2 669,92 1 693,34 0,67% Reino Unido 73,50 61,70 80,10 0,93% Taiwán 864,35 2 261,47 1 645,12 0,65% China 106,90 47,40 78,70 0,91% Irlanda 738,01 771,69 1 332,97 0,53% Suecia 204,30 76,20 75,20 0,87% China 629,77 272,37 458,89 0,18% Canadá 2,00 0,10 59,40 0,69% Canadá 186,90 16,97 416,80 0,17% Eslovenia 40,60 69,00 46,80 0,54% Yemen - - 359,25 0,14% Portugal 42,40 31,30 43,70 0,51% Portugal 555,58 398,18 358,27 0,14% EE.UU. 113,60 98,70 41,20 0,48% Eslovaquia - 319,25 333,14 0,13% Eslovaquia - 23,80 15,40 0,18% Luxemburgo 101,86 30,76 299,82 0,12% Turquía 3,10 - 15,30 0,18% Subtotal 203 294,97 227 807,93 250 868,96 99,49% Subtotal 6 641,00 8 246,80 8 614,60 99,59% TOTAL 207 214,60 230 324,68 252 158,79 100% TOTAL 7 815,30 8 336,90 8 649,80 100%

Fuente: Elaboración propia en base a datos de la aduana francesa


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E) Principales proveedores a Francia de máquinas o aparatos para empaquetar o envolver

mercancías

En valores 2007

Italia 34,94%

Alemania 30,53%

España 7,54%

Países Bajos 6,01%

Suiza 5,47%

Demás países 9,92%Bélgica 2,35%

Japón 2,71%


En volumen 2007

Italia 39,18%

Demás países 17,49%

San Marino 3,20%

Alemania 18,57%

Países Bajos 6,91%

España 6,14%

Bélgica 4,83%

Hungría 3,30%


Los principales proveedores de máquinas o aparatos para empaquetar o envolver mercancías a Francia son europeos, tanto en valor como en volumen: Italia, Alemania, España, Países Bajos, etcétera.


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F) Mercado En el mercado del envase el sector alimenticio sigue siendo el principal sector de salida para los fabricantes de envases y de máquinas. Tanto los proveedores como los compradores de este sector son optimistas con respecto a la producción a medio plazo. El 57% de los compradores y el 45% de los fabricantes prevén un crecimiento del sector alimenticio (excluyendo los líquidos). Además tanto los compradores como los proveedores son optimistas en cuanto a sus perspectivas de exportación. Lo que debería exportarse más son las líneas de embotellamiento y los equipos de fin de línea. El mercado es muy europeo pero se puede notar la emergencia de China en este sector. Francia es el primer proveedor de envases. En cuanto a los proveedores de máquinas para empaquetar las mercancías, sus principales competidores son Italia y Alemania, y luego España. Para seguir siendo competitivos y hacer frente a los riesgos del mercado, los productores franceses de máquinas y de envases intentan innovar constantemente. En este sentido se toma cada vez más en cuenta la protección del medioambiente, el desarrollo sostenible y la eco-concepción.

G) Posibles Importadores COMALFI 9, Allée de la Predecelle 78720 Cernay La Ville Tel: (33 1) 3485 1713 - Fax: (33 1) 3485 1720 CME EQUIPEMENTS 21 rue de la Planche 22190 Plerin Tel: (33 2) 9674 7912 – Fax: (33 2) 9674 4710 Email: [email protected] Web: www.jmpancinemballage.com DUBOT EQUIPEMENT WEGENER FRANCE 24, Rue Robert Witchitz 94200 Ivry sur Seine Tel: (33 1) 4681 6007 - Fax: (33 1) 4680 9079 Web: www.dubotwegener.com FRANCOPACK 6 rue de Saussure 94000 Créteil Tel: (33 1) 4513 8970 - Fax: (33 1) 4513 8979 Email: [email protected] Web: www.francopack.fr INPACO 22 rue de Dugny 95500 Bonneuil en France Tel: (33 1) 3993 4411 - Fax: (33 1) 3993 0321 Web: www.univers-emballage.com


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MATEMBAL ZI de Kervent 29250 St Pol de Leon Tel: (33 2) 9869 0438 - Fax: (33 2) 9869 2377 Contacto: Sr. Jean-Paul CHAPALAIN Email: [email protected] Web: www.matembal.com Máquinas para embolsar y pesar SARL MECADIS 3 rue des Aubuies 86200 Loudun Tel: (33 5) 4998 8852 - Fax: (33 5) 4998 8851 Web: www.mecadis.fr SMA ZA de la Corne du Cerf – BP 44 56190 Arzal Tel: (33 2) 9745 0707 – Fax: (33 2) 9745 0708 Email: [email protected] Web: www.sma-ifp.com

H) Salones y Ferias del sector IPA EMBALLAGE Salón Internacional del Envase Lugar: Paris Nord Villepinte Frecuencia: cada 2 años Próxima edición: del 17 al 21 de noviembre de 2008 Tel: (33 1) 4863 3030 - Fax: (33 1) 4863 3370 Email: [email protected] Web: www.emballageweb.com Expositores: 2 200 empresas y marcas representadas (un 53% de oferta internacional) Visitantes: más de 142 países representados CFIA Salón de los proveedores de la industria agroalimenticia Frecuencia: una vez al año Próximas ediciones: - del 10 al 12 de marzo de 2009 en Rennes, - del 20 al 22 de octubre de 2009 en Metz Tel: (33 1) 5336 7878 Email: [email protected] Web: www.cfiaexpo.com 1/3 del salón está dedicado al sector del envase Expositores: 1 200 en el 2008 Visitantes: 10 721 en el 2008


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Anexo 1: Health control of articles in contact with food products The placing on the European Union (EU) market of materials and articles intended to come into contact directly or indirectly with foodstuffs must comply with the requirements laid down in the EU legislation designed to ensure a high level of protection of human health and the interests of consumers.

These products (e.g. packaging materials, cutlery, dishes, processing machines, containers etc.) must be manufactured so that they do not transfer their constituents to food in quantities that could endanger human health, change the composition of the food in an unacceptable way or deteriorate the taste and odour of foodstuffs.

Regulation (EC) 1935/2004 (OJ L-338 13/11/2004) establishes a list of materials and articles (such us plastics, ceramics, rubbers, paper, glass, etc.) which may be subject to specific measures related to authorised substances, special conditions of use, purity standards, etc. Currently specific measures exist for ceramics, regenerated cellulose and plastics.

The label of these products shall include the text "for food contact" or shall bear the symbol with a glass and a fork.

Legislation

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27/10/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L-338 13/11/2004)

Commission Directive 2002/72/EC of 06/08/2002 relating to plastic materials and articles intended to come into contact with foodstuffs (OJ L-220 15/08/2002)

Commission Directive 2007/42/EC of 29/06/2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (OJ L-172 30/06/2007)

Council Directive 84/500/EEC of 15/10/1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs (OJ L-277 20/10/1984)

Other information sources

The area Food and Feed Safety of the European Commission's Health and Consumer Protection Directorate General (DG SANCO) website provides:

Lists and summaries of EU legislation: http://ec.europa.eu/comm/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm

Guidance documents: http://ec.europa.eu/food/food/chemicalsafety/foodcontact/documents_en.htm

Additional information for France The contents of the label must be at least in French. The compliance with the requirements and the accuracy of the information contained in the label can be checked at any stage of the distribution chain (e.g. customs clearance, distributors warehouses, wholesalers or retailers outlets…).


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Competent authority / competent bodies

Ministère de l'Economie, des Finances et de l’Industrie (Ministry of Economy, Finance and Industry) Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes (Directorate-General of the Competition, Consumer Protection and Anti-Fraud)

Bd. Vincent Auriol 59 F-75703 Paris Cedex 13 Tel: (+33) 1 44 97 24 67 Fax: (+33) 1 44 97 24 86 Website: http://www.finances.gouv.fr/DGCCRF/

Legislation

Décret no 92-631 of 08/07/1992 on the materials and articles intended to come into contact with animal or human foodstuffs (JO of 10/07/1992)

Arrêté ministériel of 28/01/1983 establishing the symbol to be borne by materials and articles intended to come into contact with foodstuffs (JO of 25/02/1983)

Arrêté of 02/01/2003 on the plastic materials and articles intended to come into contact with foodstuffs (JO of 29/01/2003)

Arrêté ministériel of 04/11/1993 on the materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (JO of 02/12/1993)

Arrêté ministériel of 07/11/1985 on the restrictions on the use of lead and cadmium in ceramic articles intended to come into contact with foodstuffs (JO of 01/12/1985)


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Anexo 2: Marketing requirements for electrical and electronic equipments In order to prevent the production and disposal of hazardous waste and to promote reuse, recycling and other forms of recovery of such waste, the placing on the European Union (EU) market of electrical and electronic equipment (EEE) is subject to the following requirements:

1. Restriction of hazardous substances (RoHS)

EEE as well as electric light bulbs and luminaires in households placed on the market after 1 July 2006 shall not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE) in amounts exceeding the set of maximum concentration values:

0.01 % by weight in homogeneous materials for cadmium 0.1 % by weight in homogeneous materials for all other substances

Certain uses of these substances, as listed in the Annex to Directive 2002/95/EC (OJ L-37 13/02/2003), are exempted from this requirement.

Medical devices and monitoring and control instruments do not fall under the scope of the RoHS Directive.

2. Waste electrical and electronic equipment (WEEE)

Directive 2002/96/EC (OJ L-37 13/02/2003) establishes the manufacturers and importers (termed "producers" under the Directive) responsibility regarding WEEE management, specifically referred to the following aspects:

The design and production of EEE must facilitate reuse and recycling of WEEE EEE placed on the market must be appropriately marked with the symbol shown in Annex IV

to Directive 2002/96/EC in order to facilitate its separate collection. Where necessary, the symbol may be printed on the packaging, on the instructions for use and on the warranty

Importers must set up individual or collective systems for the collection, treatment and recovery of WEEE and meet the recycling targets established by the Directive

When placing EEE on the market, importers must provide for a guarantee for the financing of the collection, treatment, recovery and sound disposal of waste arising from their products

Importers must provide information for users and treatment facilities on the re-use and treatment for new EEE within one year of placing it onto the market

Importers are required to register with the competent authority appointed by the Member State and have data reporting obligations relating to the amount and categories of EEE put on the market and relevant levels of recycling achieved

Legislation

Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L-37 13/02/2003)

Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE) (OJ L-37 13/02/2003)


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Additional information may be found on the DG Environment´s website:

http://ec.europa.eu/environment/waste/weee_index.htm http://ec.europa.eu/environment/waste/pdf/faq_weee.pdf

Additional information for France The compliance with substance restrictions as well as marking requirements can be checked at any stage of the distribution chain (e.g. customs clearance, distributors warehouses, wholesalers or retailers outlets…).


Agence de l'Environnement et de la Maîtrise de l'Energie – ADEME (Agency for the Environment and Energy Management) 27 rue Louis Vicat F-75737 Paris Cedex 15 Tel: (+33) 1 47 65 20 00 Fax: (+33) 1 46 45 52 36 Website: http://www.ademe.fr

Ministère de l'Économie, de l’Industrie et de l’Emploi (Ministry of Economy, Industry and Employment) Direction générale de la Concurrence, de la Consommation et de la Répression des fraudes - DGCCRF (Directorate General for Competition, Consumer Affairs and Anti-fraud) 59, Boulevard Vicent Auriol F-75703 Paris Cedex 13 Tel: (+33) 44 87 17 17 / 1 49 19 3636 Website: http://www.dgccrf.bercy.gouv.fr

Ministère de l’Ecologie, de l’Energie, du Développement durable et de l’Aménagement du territoire (Ministry of Ecology, Energy, Sustainable Development and Territorial Planning) Direction de la prévention des pollutions et des risques - DPPR (Directorate for the prevention of pollution and risks) 20 avenue de Ségur F-75302 Paris 07 SP Tel: (+33) 1 4081 2122 E-mail: [email protected] Website: http://www.developpement-durable.gouv.fr

Legislation

Décret 2005-829 of 20/07/2005 regarding the composition of electrical and electronic equipments and the disposal of waste electrical and electronic equipments (J.O. 169 of 22/07/2005)


Ministry of Economy, Industry and Employment´s website: http://www.minefi.gouv.fr/directions_services/eic/faq/deee_rohs.htm

Additional information may be found at: http://www.deee-rohs.fr/


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Anexo 3: Technical standards for electromagnetic compatibility In order to be placed on the European Union (EU) market electrical and electronic apparatus must meet the essential requirements laid down in the Electromagnetic Compatibility (EMC) Directive 2004/108/EC (OJ L-390 31/12/2004) which aims to ensure that their performance is protected against electromagnetic disturbances.

However, the placing on the market and/or the putting into service of equipment complying with the provisions of Directive 89/336/EEC which has been placed on the market before 20 July 2009 shall not be impeded.

Product Scope

Directive 2004/108/EC (OJ L-390 31/12/2004) applies to electric and electronic appliances presenting the following characteristics:

they may generate or contribute to electromagnetic emissions which exceed a level allowing radio and telecommunication equipment and other equipment to operate as intended, or

their functioning generates unacceptable degradation in the presence of the electromagnetic disturbance normally consequent upon their intended use.

The Directive is not applicable to products where the EMC aspect is covered by other specific directives (e.g. medical devices, radio and telecommunication terminal equipment, automotive vehicles) or regulations (aeronautical and marine radio products, parts and appliances, radio equipment used by radio amateurs).

Provisions related to essential requirements, conformity assessment procedures, CE and other information marks will not be compulsory for appliances which are intended for incorporation into a given fixed installation but are otherwise not commercially available.

1. Essential requirements

These electronic appliances must meet the mandatory essential requirements set out set out in Annex I in such a way that:

they do not cause electromagnetic disturbance exceeding the level above which radio and telecommunications equipment or other equipment cannot operate as intended,

they have the adequate level of immunity to such disturbance which allows them to operate without unacceptable degradation of their intended use.

2. Harmonised standards

Harmonised standards are technical specifications that would enable to meet the essential requirements. Products manufactured according to these harmonised standards benefit from a presumption of compliance with the essential requirements referred to in Annex I.

Harmonised standards are developed by the European Standardisation body: CENELEC (European Committee for Electrotechnical Standardization). It is an independent organisation whose mission is to develop voluntary electrotechnical standards, in order to promote free trade in the single European Market. The standards are published in the Official Journal of the European Communities and transposed into national legislation in the form of national standards with identical characteristics.


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A list of approved harmonised standards can be found at:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/emc.html

3. Conformity assessment

The conformity assessment process is required to certify that products comply with the essential requirements referred to in Annex I.

Compliance of apparatus shall be demonstrated by means of the procedures described in Annex II (Internal production control) and Annex III (Assessment by the notified body):

Internal production control: The manufacturer shall draw up technical documentation providing evidence of the conformity of the apparatus with the essential requirements of this Directive. Compliance of the apparatus with all relevant harmonised standards and requirements shall be attested by an EC declaration of conformity issued by the manufacturer or his authorised representative established in the EU.

Assessment by the notified body: At the discretion of the manufacturer or of his authorised representative in the Community, this procedure may also be followed. It consists of applying Annex II, completed by the presentation of the technical documentation to a notified body, which shall review it and assess whether it properly demonstrates that the requirements of the Directive have been met. The manufacturer shall add the statement of the notified body to the technical documentation

4. CE-marking

Electrical and electronic apparatus considered to meet the essential requirements set out in Annex I must bear the CE marking of conformity before being placed on the market. The CE marking shall be affixed in accordance with Annex V.

Any other mark may be affixed to the apparatus, its packaging, or the instructions for its use, provided that neither the visibility nor the legibility of the ‘CE’ marking is impaired.

The CE marking shall be accompanied by the identification number of the notified body responsible for the implementation of the procedures of conformity assessment, where the intervention of a third party is needed

5. Market Surveillance

Each Member State establishes authorities to be responsible for checking that products placed on the market meet the requirements of the applicable directives and that the affixing and use of the CE marking is correct.

Apparatus complying with the Directive enjoy free circulation within the EU. However, in case a Member State ascertains that a product bearing the CE marking does not comply with the requirements of the directive, the Member State shall withdraw the product from the market, forbid its placing on the market or restrict the free movement thereof.

The Member State shall inform the Commission and the other Member States of any measure adopted, indicating the grounds for its decision.


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Legislation

Directive 2004/108/EC 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)

Regulation EC 339/93 on checks for conformity with the rules on product safety in the case of products imported from third countries (OJ L-40 17/02/93)


European Commission - DG Enterprise and Industry , EU Guidelines on the application of the Directive 2004/108/EC: http://ec.europa.eu/enterprise/electr_equipment/emc/guides/emcguide_may2007.pdf

Additional information for France


Ministère de l'Économie, de l'Industrie et de l'Emploi (Ministry of Economy, Industry and Employment) 139, rue de Bercy F-75572 Paris Cedex 12 Tel: (+33) 1 44 97 32 16 Fax: (+33) 1 44 97 30 40 Website: http://www.minefe.gouv.fr

Standardisation body

Union Technique de l'Electricité - UTE (Technical Union for Electricity) Tour Chantecoq 5, rue Chantecoq F-92808 Puteaux Cedex Tel: (+33) 1 49 07 62 00 Fax: (+33) 1 44 78 73 51 E-mail: [email protected] Website: http://www.ute-fr.com

Conformity Assessment "Competent bodies"

List of Conformity Assessment - Competent Bodies - Electromagnetic compatibility

Notified bodies

List of bodies notified under Directive 2004/108/EEC - Electromagnetic compatibility

Market Surveillance body

List of Central Contact Points in charge of Market Surveillance - Electromagnetic compatibility

Legislation

Décret Nº 2006-1278 of 18/10/2006 on electromagnetic compatibility of electronic and electrical appliances (JO of 20/10/2006).


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Anexo 4: Technical standards for low voltage electrical equipment The placing on the European Union (EU) market of low-voltage electrical equipment is subject to the compliance with mandatory essential requirements established by Directive 2006/95/EC (OJ L-374 27/12/2006) in order to ensure the safety of persons, domestic animals or property.

Product scope

The Directive covers electrical equipment (including some components intended for incorporation into other equipment) designed for the use with a voltage rating:

between 50 and 1000 V for alternating current; between 75 and 1500 V for direct current.

In particular, products such as electrical appliances, lighting equipment, electric wiring, appliance couplers and cord sets, or electrical installation equipment, are covered by the Directive.

Equipment outside the scope of the Directive is listed in Annex II to the Directive.

Essential requirements

The essential safety requirements, which are laid down in Annex I to the Directive, protect against risks arising from the use of the electrical equipment and risks which may be caused by external influences on the electrical equipment, including not just electrical ones but also mechanical, chemical and any other risk (noise, vibrations…).

Harmonised standards

The technical specifications to meet the essential requirements are not described in the Directive. However, products are presumed to conform to the essential safety requirements where they have been manufactured in accordance with:

- The harmonised standards drawn up by the European Committee for Electrotechnical Standardisation (CENELEC) on the basis of the essential requirements set in the Directive; or

- In the absence of harmonised standards, international rules issued by the International Electrotechnical Commission (IEC).

The manufacturer may construct the product without applying harmonised or international standards but, in such a case, the product will not benefit from presumption of conformity and the manufacturer must include in the technical documentation a description of the solutions adopted to meet the essential safety requirements.

Conformity assessment

Before a product is placed on the EU market, the manufacturer must ensure and declare conformity of the electrical equipment with the provisions of the Directive in order to affix the CE marking.

The manufacturer must affix the CE marking to each product and draw up a written declaration of conformity. Annex IIIb describes the content of the declaration of conformity.

The manufacturer must compile the technical documentation (covering the design, manufacture and operation of the product) which enables to assess whether the electrical equipment complies with


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the requirements of the Directive. This documentation, together with a copy of the declaration of conformity, must be kept at the disposal of the competent national authorities for inspection purposes for a period of 10 years from the date of manufacture of the product. The contents of this documentation are detailed in Annex IV.

Where neither the manufacturer nor his authorised representative are established within the EU, the importer or the person first placing the product on the EU market is responsible for ensuring the technical documentation.

In case of low-voltage electrical equipment, there is no third party intervention in the conformity assessment procedure. However, a third party (notified body) may provide reports in response to a challenge by a market surveillance authority of the Member State as to the conformity of the equipment. This report is considered an element of proof.

Notified bodies are organisations designated by each Member State and notified to the Commission and the other Member States, that are in charge of assesing manufaturer's conformity to the esssential requirements when a third party is required.

CE Marking

All electrical equipment marketed in the EU must be provided with a CE conformity marking, as depicted in Annex III to the Directive, which symbolises the conformity of the equipment with the essential requirements. It shall be affixed on the product, on the packaging, the instructions for use or the guarantee in a visible, easily legible and indelible way.

The Directive provides for procedures and sanctions established by the Member States for cases where the CE mark has been affixed unduly.

Market surveillance


Market surveillance can be done by testing products, checking administrative and technical documentation and visiting factories.

Products complying with the Directive enjoy free circulation within the EU. However, in case a Member State finds that the CE Marking has been affixed unduly, the manufacturer or his authorised representative established within the EU must make the product conform to the essential safety requirements. Otherwise, the Member State must restrict or forbid the placing on the market of this product, or even remove it from the market.

According to Regulation 339/93 (OJ L-040 17/02/1993), Member States' customs authorities shall also control the conformity of the product at the points of entry into the EU.

Legislation

Directive 2006/95/EC of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (OJ L-374 27/12/2006)

Council Regulation (EEC) 339/1993 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (OJ L-40 17/02/1993)


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European Commission - DG Enterprise and Industry, Guidelines on the application of the Low Voltage Directive and recommendations: http://ec.europa.eu/enterprise/electr_equipment/lv/guides/index.htm

Lits with examples of products within or outside of the scope of the Low Voltage Directive (LVD): http://ec.europa.eu/enterprise/electr_equipment/lv/guides/list-examples.pdf




Union Technique de l'Electricité - UTE (Technical Union for Electricity) Bureau de normalisation auprès de l'AFNOR (Bureau for Standardisation before AFNOR) Tour Chantecoq 5, rue Chantecoq F-92808 Puteaux Cedex Tel: (+33) 1 49 07 62 00 Fax: (+33) 1 44 78 73 51 E-mail: [email protected] Website: http://www.ute-fr.com/

Notified bodies

List of bodies notified under Directive 73/23/EEC - Low voltage.

Market surveillance authority

Ministère de l'Économie, de l'Industrie et de l'Emploi (Ministry of Economy, Industry and Employment) Direction Générale de la Consommation, de la Concurrence et de la Répression des Fraudes - DGCCRF (Directorate-General of Consumer Affairs, Competition and Anti-Fraud) 59 Boulevard Vincent Auriol F-75703 Paris Cedex 13 Tel: (+33) 1 44 87 17 17 Fax: (+33) 1 44 97 30 40 Website: http://www.dgccrf.bercy.gouv.fr/

Legislation

Décret No. 95-1081 of 03/10/1995 on the safe use of electric materials working within certain output limits (JO of 07/10/1995)


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Anexo 5: Technical standards for machinery and safety components In order to be placed on the European Union (EU) market, the design and construction of machinery must meet the requirements which have been established by the EU legislation with a view to protecting the safety of persons using such machinery.

Product scope

Directive 98/37/EC (OJ L-207 23/07/1998) covers machinery and its safety components establishing the mandatory essential health and safety requirements which they must satisfy before being marketed in the EU in order to eliminate any risk of accident.

Certain types of machinery (e.g. lifts, cableways, medical devices, agricultural and forestry tractors,…) are covered by specific Directives and they are therefore excluded from the scope of this Directive.

Essential requirements

The essential safety requirements protect against any risk caused by the use of machinery (mechanical risks, electrical risks, extreme temperatures, fire, explosion, noise, radiation, emission of gases, risk of being trapped in a machine, etc.).

They cover aspects such as the design of the machine to facilitate its handling, the instructions of use, ergonomics, materials, control systems, maintenance, warnings, etc.

The Directive arranges more specific health and safety requirements for certain categories of machinery or for certain hazards.

Harmonised standards

Harmonised standards are technical specifications that would enable to meet the essential requirements. Products manufactured according to these harmonised standards benefit from a presumption of compliance with the essential requirements.

Harmonised standards are developed by the European Standardisation bodies: CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization). These bodies are independent organisations whose mission is to develop respectively voluntary technical and electrotechnical standards, in order to promote free trade in the single European Market. The standards are published in the Official Journal of the European Communities and transposed into national legislation in the form of national standards with identical characteristics.

List of references of harmonised standards for machinery: http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/machines.html

Conformity assessment

There are two different procedures depending on the risk factor of the product:

A) Machinery and safety components included in Annex IV to the Directive

As they have a high risk factor, the intervention of a third party (notified body) is needed for the design phase.


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Notified bodies are organisations designated by each Member State and notified to the Commission and the other Member States, that are in charge of assesing manufaturer's conformity to the esssential requirements when a third party is required.

The manufacturer submits a technical file and an example of the product to a notified body, which ascertains conformity to the Directive, carries out tests, if necessary, and issues an EC type examination certificate. The production must conform to the approved type.

B) Machinery and safety components not included in Annex IV to the Directive

The manufacturer is responsible for certifying the conformity of his machinery to the relevant essential requirements in order to affix the CE mark. He can voluntarily have his products examined and certified by a third party (notified body) where harmonised standards are not available or the manufacturer considers them inappropriate.

The manufacturer must draw up the EC declaration of conformity according to the guidelines given in Annex II. Before, the manufacturer or his authorised representative established in the EU has to compile a technical construction file which must be kept available to the competent Member State authorities for 10 years from the date of manufacture of the product.. This file must contain all the relevant documentation which enables to assess the conformity of the machine with the essential requirements. Annex V to the Directive, lists all the information to be included.

Where neither the manufacturer nor his authorised representative are established within the EU, the importer or the person first placing the product on the EC market is responsible for ensuring the technical documentation.

CE Marking

Before being placed on the market, individually marketed safety components of machinery do not carry the CE marking, but they must be accompanied by the EC declaration of conformity. This document is issued by the manufacturer in order to certify that the products meet the essential requirements established by the Directive.

Machines must be accompanied by an EC declaration of conformity and bear the CE mark, which is depicted in Annex III, certifying their conformity to the Directive.

Market surveillance


Market surveillance can be done by testing products, checking administrative and technical documentation and visiting factories.

Machinery and safety components complying with the Directive enjoy free circulation within the EU. However, in case the authorities of a Member State find that the product does not comply with the essential safety requirements, they must restrict or forbid the placing on the market of this product, or even remove it from the market where other corrective measures have failed.

Member States customs authorities shall also control the conformity of the product with the essential requirements at the points of entry into the EU.


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Legislation

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 23/07/1998)


European Commission - DG Enterprise and Industry; Comments on Directive 98/37/EC: http://ec.europa.eu/enterprise/mechan_equipment/machinery/guide/content.htm




Association Française de Normalisation - AFNOR (French Standardisation Association) 11, Rue Francis de Pressensé F-93571 Saint-Denis la Plaine Cedex Tel: (+33) 1 41 62 80 00 / (+33) 1 41 62 76 44 Fax: (+33) 1 49 17 90 00 E-mail: [email protected] Website: http://www.afnor.org/portail.asp

Notified bodies

List of bodies notified under Directive 98/37/EC - Machinery.

Market Surveillance authorities

Ministère du Travail, des Rélations Sociales, de la Famille et de la Solidarité (Ministry of Labour, Social Relations, Family and Solidarity) Direction des Relations du Travail (Department of Labour Relations) 39-43, quai André Citroën F-75902 Paris Cedex 15 Tel: (+33) 1 44 38 38 38 Fax: (+33) 1 44 38 27 11 Website: http://www.travail-solidarite.gouv.fr/

Ministère de l'Économie, de l'Industrie et de l'Emploi (Ministry of Economy, Industry and

Employment) Direction Générale de la Consommation, de la Concurrence et de la Répression des Fraudes - DGCCRF (Directorate-General of Consumer Affairs, Competition and Anti-Fraud) 59, boulevard Vincent Auriol F-75703 Paris cedex 13 Tel: (+33) 1 44 87 17 17 Fax: (+33) 1 44 87 30 40 Website: http://www.minefi.gouv.fr/DGCCRF/index.html


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Legislation

Loi No. 91-1414 of 31/12/1991 amending the Labour Code and the Public Health Code aiming at preventing professional risks and implementing the transposition of European Union directives related to public health and safety at work (JO of 07/01/1992 Page 319) (Articles L. 233-5 to L. 233-6 of the Labour Code)

Décret No. 92-765 of 29/07/1992 on working equipment and means of protection under obligations defined by L. 233.5 of the Labour Code and amending the Labour Code (Second Part: Décrets en Conseil d'Etat) (JO of 07/08/1992 Page 10689) (Articles R. 233-83 to R. 233-83-2 of the Labour Code)

Décret No. 92-766 of 29/07/1992 defining conformity assessment procedures and diverse modalities for assessment control of working equipment and means of protection and amending the Labour Code (Second Part : Conseil d'Etat) (JO of 07/08/1992 Page 10690) (Articles R. 233-49 to R. 233-57, R.233-59 to R. 233-65, R. 233-73 to R. 233-76-1 and R. 233-78 to R. 233-81-2 of the Labour Code)

Décret No. 92-767 of 29/07/1992 on technical rules and conformity assessment procedures applicable to work equipment aiming at 1°,3°,4° and 5° of Article R.233-83 of the Labour Code and to means of protection aiming at 1° and 2° of Article R. 233-83-2 of the Labour Code and amending the Labour Code (Second Part : Décrets au Conseil d'Etat) (JO of 07/08/1992 Page 10696) (Articles R. 233-84, Annex I Book II, and Articles R. 233-85 to R. 233-89 of the Labour Code)

Décret No. 96-725 of 14/08/1996 on technical rules and procedures of conformity assessment applicable to working equipments and means of protection under the scope of Article L.233-5 of the Labour Code, amending the Labour Code (Second part: Décrets en Conseil d'Etat) and implementing the transposition of diverse European directives (JO of 18/08/1996)

Arrêté of 07/02/1997 on CE labelling of working equipments and individual protection equipments (JO of 28/02/1997)

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