Importación UE

21/5/2020 Mi exportación | Trade Helpdesk
Notas
El acceso directo al Diario Oficial solo es posible para las ediciones publicadas después de 1997.
Todas las referencias legales mencionadas se refieren solo a la ley original. El uso del número CELEX proporcionado (por
ejemplo, CELEX32005R0396) permitirá el acceso a la legislación básica, todas las enmiendas y la versión consolidada de la
legislación siempre que esté disponible en EUR-Lex (base de datos de leyes de la Unión Europea).
Fecha de última revisión (dd / mm / aaaa): 01/03/2020
Unión Europea - Resumen de los procedimientos de importación

(*) El Reino Unido se retiró de la Unión Europea y es un tercer país a partir del 1 de febrero de 2020.
Durante el período de transición, que finaliza el 31 de diciembre de 2020, la legislación de la Unión, con algunas
excepciones limitadas, sigue siendo aplicable en y para el Reino Unido.
Tabla de contenido:
https://trade.ec.europa.eu/tradehelp/myexport#?product=0800000000&partner=CO&reporter=DE#Introduction 1/21
1. Introducción (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#Introduction)
2. Unión aduanera (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_CustomsUnion)
3. Mercado único (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_SingleMarket)
4. Clasificación de productos en nomenclaturas arancelarias
(https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#Nomenclature)
5. Régimen de comercio de importación
product=0800000000&partner=CO&reporter=DE#EU_ImportTradeRegime)
6. Seguridad de alimentos y piensos
product=0800000000&partner=CO&reporter=DE#EU_FoodSafety)
7. Salud animal (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_AnimalHealth)
8. Salud de las plantas (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_PlantHealth)
9. Salud pública (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_Publichealth)
10. Proteccion Ambiental (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_EnvironmentProtection)
11. Normas de comercialización de productos agrícolas y pesqueros.
product=0800000000&partner=CO&reporter=DE#EU_Marketingstandards)
12. Seguridad del producto (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_ProductSafety)
13. Estandarización Técnica (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_TechnicalStandardisation)
14. embalaje (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_Packaging)
15. Etiquetado (https://trade.ec.europa.eu/tradehelp/myexport#?
product=0800000000&partner=CO&reporter=DE#EU_Labelling)
1. Introducción
Este documento tiene la intención de dar una visión general de los requisitos de la Unión Europea (UE o la Unión) que deben
cumplirse al importar productos de países en desarrollo. Estas medidas se adoptan para proteger la salud pública, el medio
ambiente, las demandas de los consumidores, etc.
Este resumen es un resumen de las políticas más relevantes de la Unión Europea. También proporciona fuentes de información de
la Comisión Europea, así como de otras instituciones europeas e internacionales donde encontrar más detalles.
No se prevé la provisión de una lista exhaustiva de todos los requisitos de importación con este documento.
Se puede acceder a información más precisa del producto en la Sección de Requisitos e Impuestos mediante la introducción del
código específico de Nomenclatura Combinada, el país de origen y el Estado Miembro de destino en el formulario de entrada.
2. Unión aduanera
Los 27 Estados miembros de la UE forman un territorio único a efectos aduaneros. Esto implica que la UE es una Unión Aduanera
(http://ec.europa.eu/taxation_customs/customs/policy_issues/customs_strategy/index_en.htm) , lo que significa que sus Estados
miembros no tienen barreras arancelarias entre ellos y todos tienen un arancel aduanero común para las mercancías importadas.
Además, una vez que los derechos de aduana se han pagado debidamente y se ha inspeccionado el cumplimiento de las
condiciones de importación, los bienes importados pueden circular libremente dentro del resto de la UE sin ningún otro control
aduanero.
El territorio aduanero de la Unión incluye los territorios de los siguientes Estados miembros:
- Bélgica,
- Bulgaria,
- Croacia,
- la República Checa,
- Dinamarca, excepto las Islas Feroe y Groenlandia,
- Alemania, excepto la isla de Heligoland y el territorio de Büsingen,
- Estonia,
- Irlanda,
- Grecia,
- España, excepto Ceuta y Melilla,
- Francia, excepto Nueva Caledonia, San Pedro y Miquelón, Islas Wallis y Futuna, Polinesia Francesa y Territorios Australes y
Antárticos Franceses, pero incluyendo los departamentos de ultramar de Guadalupe, Guayana Francesa, Martinica, Islas Mayotte y
Reunión,
- Italia, excepto los municipios de Livigno y Campione d'Italia y las aguas nacionales del lago de Lugano, que se encuentran entre
el banco y la frontera política de la zona entre Ponte Tresa y Porto Ceresio,
- Chipre (pendiente de una solución al problema de Chipre, la aplicación del acervo comunitario se suspende en aquellos ámbitos
en los que el Gobierno de la República de Chipre no ejerce un control efectivo),
- Letonia,
- Lituania,
- Luxemburgo,
- Hungría,
- Malta,
- los Países Bajos en Europa,
- Austria,
- Polonia,
- Portugal,
- Rumania,
- Eslovenia,
- la República Eslovaca,
- Finlandia,
- Suecia,
- el Reino Unido de Gran Bretaña e Irlanda del Norte y de las Islas del Canal y la Isla de Man (*).
Los siguientes territorios, incluidas sus aguas territoriales, las aguas marítimas continentales y el espacio aéreo, situados fuera del
territorio de los Estados miembros, también se considerarán parte del territorio aduanero de la Comunidad:
- el territorio del principado de Mónaco

- el territorio de las Áreas Soberanas del Reino Unido de Akrotiri y Dhekelia, en Chipre (*).
Código aduanero de la Unión (UCC)

La mayor parte de las normas que rigen las aduanas de la UE están contenidas en el Código Aduanero de
(http://ec.europa.eu/taxation_customs/business/union-customs-code/ucc-legislation_en) la Unión (UCC)
(http://ec.europa.eu/taxation_customs/business/union-customs-code/ucc-legislation_en)
(http://ec.europa.eu/taxation_customs/customs/procedural_aspects/general/community_code/index_en.htm) . Este Código,

adoptado en el Reglamento (UE) no 952/2013 del Parlamento Europeo y del Consejo (DO L-269 10/10/2013) (CELEX
32013R0952) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32013R0952:EN:NOT) , así como la siguiente
legislación de aplicación, cubre todos los asuntos aduaneros relacionados con el comercio con países extranjeros:
Reglamento Delegado (UE) 2015/2446 de la Comisión (DO L-343 29/12/2015) (CELEX 32015R2446) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32015R2446:EN:NOT) , que complementa ciertos elementos no
esenciales de la UCC
Reglamento de Ejecución (UE) 2015/2447 de la Comisión (DO L-343 29/12/2015) (CELEX 32015R2447) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32015R2447:EN:NOT) que establece disposiciones para la aplicación
uniforme de la UCC y la aplicación de procedimientos por parte de todos los Estados miembros
Reglamento Delegado (UE) 2016/341 de la Comisión (DO L-69 15/03/2016) (CELEX 32016R0341) que (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32016R0341:EN:NOT) establece normas transitorias para los
operadores y las autoridades aduaneras hasta que se aplique un entorno aduanero completamente electrónico como se
establece en las disposiciones de la UCC
Decisión de Ejecución 2016/578 de la Comisión (DO L-99 15/04/2016) (CELEX 32016D0578) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32016D0578:EN:NOT) , que establece el Programa de trabajo sobre el
desarrollo y despliegue de los sistemas electrónicos previstos en la UCC
Estas disposiciones garantizan prácticas aduaneras uniformes y transparentes en todos los Estados miembros de la UE.
El número EORI
EORI significa Registro e Identificación de Operador Económico. El EORI comenzó en toda la UE el 1 de julio de 2009.
El número EORI es un identificador, único en toda la UE, asignado por una autoridad aduanera en un Estado miembro a
operadores económicos (EO), tanto empresas (personas jurídicas) como personas físicas. Al registrarse con fines aduaneros en un
Estado miembro, una OE puede obtener un número EORI válido en toda la UE.
El operador utilizará este número en todas las comunicaciones con las autoridades aduaneras de la UE donde se requiera un
identificador basado en la UE, por ejemplo, en las declaraciones de aduanas.
Los operadores económicos establecidos fuera de la UE solo deben tener asignado un número EORI si presentan una declaración
de aduana, una declaración de resumen de entrada (ENS) o una declaración de resumen de salida (EXS).
La aplicación de EORI garantizará que las medidas para mejorar la seguridad introducidas por la Enmienda de Seguridad
(Reglamento (CE) no 648/2005 del Parlamento Europeo y del Consejo (DO L-117 04/05/2005) (CELEX 32005R0648) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32005R0648:EN:NOT) ) del antiguo Código de Aduanas de la Comunidad y
del Código de Aduanas de la Unión en la actualidad, será más eficaz, ya que las OE pueden identificarse por referencia a un
número único, común a todos los Estados miembros de la UE.
Se puede encontrar más información en el Documento de orientación sobre las formalidades aduaneras de entrada e importación
en la Unión Europea,
(https://ec.europa.eu/taxation_customs/sites/taxation/files/docs/body/guidance_customs_formalities_entry_import_en.pdf/) en las
Directrices EORI (http://ec.europa.eu/ecip/documents/who_is/taxud1633_2008_rev2_en.pdf/) y en la página de los sitios web
nacionales de aduanas para obtener información sobre las aduanas de Estados miembros específicos.
Declaración resumida de entrada

A partir del 1 de enero de 2011, el transportista de mercancías que ingresa al territorio aduanero de la UE debe presentar
información de carga anticipada en la primera oficina de aduanas de entrada a la UE. Esta información se proporciona a través de
la Declaración sumaria de entrada (ENS) que el transportista debe presentar por adelantado, aunque en algunos casos también
puede hacerlo el importador-consignatario o un representante del transportista o importador. La declaración ENS debe presentarse
incluso si las mercancías no se van a importar a la UE.
Los plazos para el alojamiento de la ENS varían según el modo de transporte que transporta las mercancías al territorio aduanero
de la UE:
Carga marítima de contenedores: al menos 24 horas antes del comienzo de la carga en el puerto de carga extranjero.
Carga marítima a granel: al menos 4 horas antes de la llegada.
Envío por mar corto: al menos 2 horas antes de la llegada.
Vuelos de corta distancia (menos de 4 horas de duración): al menos en el momento del despegue real de la aeronave.
Vuelos de larga distancia (duración de 4 horas o más): al menos 4 horas antes de la llegada al primer aeropuerto en el
territorio aduanero de la Comunidad.
Tráfico por carretera: al menos 1 hora antes de la llegada.
Parte de la información que el transportista debe incluir en la ENS proviene de documentos originados por el exportador:
conocimiento de embarque, facturas comerciales ... por lo que es crucial que estos lleguen a la parte responsable de la
presentación de la ENS de manera oportuna y precisa conducta.
La declaración ENS entra en el ámbito del Sistema de Control de Importaciones (ICS), que entró en pleno funcionamiento el 1 de
enero de 2011, como parte de la Enmienda de Seguridad establecida por el Reglamento (CE) no 648/2005 del Parlamento
Europeo y del Consejo . La UCC ha introducido varios cambios en esta declaración para obtener información más detallada para el
análisis de riesgos. Las especificaciones detalladas se definirán en 2017 y 2018.
También está disponible un documento de orientación sobre las formalidades aduaneras de entrada e importación en la Unión
Europea (https://ec.europa.eu/taxation_customs/sites/taxation/files/docs/body/guidance_customs_formalities_entry_import_en.pdf/)
, que incluye información sobre la ENS.
Procedimientos de importación
Las mercancías importadas en el territorio aduanero de la UE deben ir acompañadas de una declaración sumaria, que se presenta
a las autoridades aduaneras del lugar donde deben descargarse. Luego, las mercancías se colocan en una situación de
almacenamiento temporal (en cualquier caso, que no exceda los 90 días), lo que significa que se almacenan bajo supervisión
aduanera hasta que se colocan en cualquiera de los siguientes procedimientos aduaneros o se reexportan:
1. Despacho a libre práctica

Las mercancías se despachan a libre práctica cuando se cumplen debidamente las condiciones relativas a la importación en la UE
(pago de derechos arancelarios y otros cargos, según corresponda, aplicación de medidas de política comercial no arancelarias y
cumplimiento de los demás trámites relacionados con la importación de los buenos). El despacho a libre práctica confiere a las
mercancías no pertenecientes a la Unión el estatuto aduanero de «mercancías de la Unión».
Una vez que se han pagado los aranceles mencionados, así como el impuesto al valor agregado (IVA) y los impuestos especiales
aplicables, los bienes se `` liberan para el consumo '', ya que cumplen las condiciones para el consumo en el Estado miembro de
destino.
2. Procedimientos especiales
Los productos pueden colocarse en cualquiera de las siguientes categorías de procedimientos especiales:
Tránsito , que comprende el tránsito externo e interno:
External transit: non-Union goods may be moved from one point to another within the customs territory of the Union without
being subject to import duties, other charges related to the import of the goods (i.e. internal taxes) and commercial policy
mesures, thereby transferring customs clearance formalities to the customs office of destination.
Internal transit: Union goods may be moved from one point to another within the customs territory of the Union, passing
through a country or territory outside that customs territory, without any change in their customs status.
Storage, which comprises customs warehousing and free zones:

Customs warehousing: non-Union goods may be stored in premises or any other location authorised by the customs
authorities and under customs supervision ('customs warehouses') without being subject to import duties, other charges
related to the import of the goods and commercial policy measures.
Free zones: Member States may designate parts of the customs territory of the Union as free zones. They are special areas
within the customs territory of the Union where goods can be introduced free of import duties, other charges (i.e. internal
taxes) and commercial policy measures, until they are either assigned another approved customs procedure or re-exported.
Goods may also undergo simple operations such as processing and re-packing.
Specific use, which comprises temporary admission and end-use:
Temporary admission: non-Union goods intended for re-export may be subject to specific use in the customs territory of the
Union, with total or partial relief from import duty, and without being subject to other charges like internal taxes and
commercial policy measures. This procedure may only be used provided that the goods are not intended to undergo any
change. The maximum period during which goods may remain under this procedure is 2 years.
End-use: goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their
specific use.
Processing, which comprises inward and outward processing:
Inward processing: goods are imported into the Union in order to be used in the customs territory of the Union in one or more
processing operations, without being subject to import duties, taxes and commercial policy measures. . The customs
authorities shall specify the period within which the inward processing procedure is to be discharged. Where finished products
are not finally exported, these shall be subject to the appropriate duties and measures
Outward processing: Union goods may be temporarily exported from the customs territory of the Union in order to undergo
processing operations. The processed products resulting from those goods may be released for free circulation with total or
partial relief from import duties.
European Commission, Taxation and Customs Union, UCC Guidance documents:

https://ec.europa.eu/taxation_customs/business/union-customs-code/ucc-guidance-documents_en#import_and_entry
(https://ec.europa.eu/taxation_customs/business/union-customs-code/ucc-guidance-documents_en#import_and_entry)
Customs declaration - SAD (Single Administrative Document)

The placing of the goods under any customs approved treatment or use is done using the Single Administrative Document (SAD)
(http://ec.europa.eu/taxation_customs/customs/procedural_aspects/general/sad/index_en.htm), which is a common form for all the
EU Member States according to the Union Customs Code and the Transitional Delegated Act (Commission Regulation (EU)
2016/341) whereas a fully electronic customs environment is created.
The SAD can be presented to the customs authorities by the importer or his representative. The representation may be:
direct representation: representatives act in the name of, and on behalf of, another person;
indirect representation: representatives act in their own name but on behalf of another person.
The SAD may be presented either by:
electronic means directly linked to the customs authorities (each Member State may have its own system);
or by lodging it with the designated customs office premises.
European Commission, Taxation and Customs Union, SAD Guidance during the UCC transitional period:
https://ec.europa.eu/taxation_customs/sites/taxation/files/docs/body/guidance_transitional_sad_en.pdf
(https://ec.europa.eu/taxation_customs/sites/taxation/files/docs/body/guidance_transitional_sad_en.pdf/)
Value for Customs purposes
Customs authorities use the value of imported goods as one of the elements to assess the amount of duty (customs debt), which
has to be paid before goods can enter the EU, since most customs duties and VAT are expressed as a percentage of the value of
the goods being declared.
The definition of the value for customs purposes relies on the concept of 'transaction value', which is the commercial value of the
merchandise at the point of entry in the EU. At large, this value is the total amount of purchase price and delivery costs up to the
point where the goods enter the customs territory. This value is not always equal to the price that appears on the sales contract and
may be subject to specific adjustments.
European Commission, Taxation and Customs Union, Value of Declared Goods:

http://ec.europa.eu/taxation_customs/customs/customs_duties/declared_goods/index_en.htm
(http://ec.europa.eu/taxation_customs/customs/customs_duties/declared_goods/index_en.htm)
3. Single Market
The European Single Market is guaranteed by the principle of free movement of goods
(http://ec.europa.eu/enterprise/policies/single-market-goods/free-movement-non-harmonised-sectors/index_en.htm). This principle
determines the abolition of border controls, customs duties and all trade barriers among Member States.
The free movement of goods within the EU is achieved through:
The principle of non-discrimination.

This principle entails that lawfully imported goods cannot receive different treatment from similar domestic products on the basis of
their origin, except for some permitted exceptions.
The mutual recognition principle.

According to this principle, (http://ec.europa.eu/enterprise/policies/single-market-goods/free-movement-non-harmonised-
sectors/mutual-recognition/index_en.htm) any product lawfully produced and marketed under the regulations of a Member State
must, in principle, be admitted to the market of any other Member State.
Legislative harmonisation.
This regulatory technique is aimed to the approximation of national legislation of the Member States. The main EU instrument to
achieve this harmonisation is the Directive. Directives set up a structure to which the internal legislation of the Member States must
conform by adopting new laws or regulations, or amending existing ones, so that national laws in all Member States are
harmonised.
European Union, Summaries of Legislation, European Community legal instruments:

http://eur-lex.europa.eu/browse/summaries.html (http://eur-lex.europa.eu/browse/summaries.html)
European Union, Summaries of Legislation, Transposition into national law of directives relating to the internal market:
http://ec.europa.eu/internal_market/scoreboard/performance_by_governance_tool/transposition/index_en.htm
(http://ec.europa.eu/internal_market/scoreboard/performance_by_governance_tool/transposition/index_en.htm)
4. Product Classification in Tariff Nomenclatures
The correct classification of a particular product under a tariff code is the first step to obtain relevant information on it, such as:
the level of duty rates and other applicable levies on import and export;
the possible application of certain measures such as anti-dumping;
external trade statistics;
import and export formalities, and other non-tariff requirements.
Harmonised System, Combined Nomenclature and Taric Code

The Harmonised System or 'HS' (Harmonised Commodity Description and Coding System) is a nomenclature developed by the
World Customs Organisation (WCO) (http://www.wcoomd.org) which comprises about 5 000 commodity groups, organised by
Sections, Chapters (2 digit), Headings (4 digits) and Sub-headings (6 digits). The logic of the products classification relies on a
hierarchical structure. In order to facilitate a uniform interpretation, the HS is supported by implementation rules and explanatory
notes.
The European Union and its Member States apply the Harmonised System for tariff classification. The system is used by more than
200 countries (http://www.wcoomd.org/files/1.%20Public%20files/PDFandDocuments/HarmonizedSystem/HS-Eng_20090116.pdf/)
as a basis for their customs tariffs and for international trade statistics.
The Combined Nomenclature (CN) is the European Union's coding system for classifying products, which was established to
meet the requirements both of the Common Customs Tariff and of the international and intra-EU trade statistics. It is an 8-digit
coding system, which is composed of the HS nomenclature with further EU subdivisions.
The Integrated Tariff of the European Communities (TARIC) identifies goods with a view to include all trade policy and tariff
measures applicable in the EU (such as temporary suspension of duties, antidumping duties, etc.). Its structure is based on the 8-
digit code of the CN and on two additional digits (Taric subheadings), as depicted in the example:
- Optical, photographic, cinematographic, measuring, checking, precision, medical or

90 (HS Chapter)
surgical instruments and apparatus; parts and accessories thereof
- - Surveying (including photogrammetrical surveying), hydrographic, oceanographic,
9015 hydrological, meteorological or geophysical instruments and appliances, excluding (HS Heading)
compasses; rangefinders
9015.10 - - - Rangefinders (HS Subheading)
9015.10.10 - - - - Electronic (CN Code)
9015.10.10.10- - - - - For use in certain types of aircraft (Taric code)
9015.10.10.90- - - - - Other (Taric code)
European Commission, Taxation and Customs Union, Harmonised system:
http://ec.europa.eu/taxation_customs/customs/customs_duties/tariff_aspects/harmonised_system/index_en.htm
(http://ec.europa.eu/taxation_customs/customs/customs_duties/tariff_aspects/harmonised_system/index_en.htm)
5. Import Trade Regime

The EU, as a member of the World Trade Organization (WTO) (http://www.wto.org/English/tratop_e/tratop_e.htm), embraces the
rule of 'free importation' for its Common Import Regime. This rule implies that the EU encourages liberal trade policies to ease the
flow of goods and services through its borders, implementing the principles of binding tariffs and of non-discrimination between
trading partners.
Nevertheless, there are some exceptions to this general rule, where the EU implements Trade Defence Instruments designed after
some WTO agreements which recognise the right of its members to counter unfair trade practices. The instruments set by the EU
are the following:
1. Surveillance measures are not import restrictive instruments but a system of mandatory import licences issued by the EU
Member States' authorities for monitoring purposes. These measures are applied principally on some agricultural, textile and
steel products.
2. Quantitative Limits on imports of some products originating from certain third countries are aimed to protect European
producers against harmful mass importations at a very low price.
3. Safeguard measures are applied on a case-by-case basis to imports which cause or threaten to cause damage to the EU
industry. They consist in the temporary and emergency restriction of some specific imports. The procedure to impose these
measures can be started either at the request of a Member State or at the European Commission's own initiative; however
industry cannot directly lodge a request. Nevertheless, these measures must anyhow respect the WTO Agreement on
Safeguards.
Import restrictions are implemented in the following sectors:
A. Agricultural Products
Imports into the EU of certain agricultural products may be subject to the presentation of an import certificate, issued by the
competent authorities of the EU Member States, prior to clearance for free circulation, upon request from the importer and security
deposit returnable on giving proof of the import.
Import certificates serve several purposes such as monitoring trade flows and providing for the administration of tariff quotas or
safeguard measures.
European Commission, Trade, Agricultural Policy and Trade:

http://ec.europa.eu/trade/issues/sectoral/agri_fish/agri/index_en.htm
(http://ec.europa.eu/trade/issues/sectoral/agri_fish/agri/index_en.htm)
B. Textiles
The import regime of textile products into the EU is free.
European Commission, Trade, Textile sector:

(http://ec.europa.eu/trade/issues/sectoral/industry/textile/index_en.htm)http://trade.ec.europa.eu/sigl/info_textile.htm
(http://trade.ec.europa.eu/sigl/info_textile.htm)
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products:
http://trade.ec.europa.eu/sigl/ (http://trade.ec.europa.eu/sigl/)
C. Iron, Steel and Aluminium Products

Imports into the EU of certain iron, steel and aluminium products are subject to different control measures, which may consist either
in a prior European Community surveillance, or in a double-checking system with or without quantitative restrictions.
Different schemes apply depending on the country of origin and the type of product.
European Commission, Trade, Steel sector:

http://trade.ec.europa.eu/sigl/info_steel.htm (http://trade.ec.europa.eu/sigl/info_steel.htm)
European Commission, Trade, Integrated system for the management of licences for imports of textiles, clothing and steel products:
http://trade.ec.europa.eu/sigl/ (http://trade.ec.europa.eu/sigl/)
6. Food and Feed Safety

The central goal of the EU legislation on food safety is to ensure a high level of protection of human health and consumers' interests
in relation to food, whereas EU rules on animal feed are aimed towards the protection of human and animal health, and to some
extent to environmental protection.
Regulation (EC) No 178/2002 of the European Parliament and of the Council (OJ L-31 01/02/2002) (CELEX 32002R0178)
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32002R0178:EN:NOT) lays down the general principles and
requirements of Food Law, and covers all stages of food/feed production and distribution. Importers of food and feed products
would be required to identify and register from whom the product was exported in the country of origin, in view of fulfilling the
requirements for traceability.
The European Food Safety Authority (EFSA) (http://www.efsa.europa.eu) provides the European Commission with independent
scientific advice on all matters with direct or indirect impact on food safety. It is a separate legal entity, independent from the other
EU institutions.
Imports of foodstuffs must comply with general conditions and measures, which include:
General principles and requirements of Food Law established in Regulation (EC) No 178/2002 of the European Parliament
and of the Council.
General foodstuffs hygiene rules and hygiene specifications for food of animal origin according to Regulations (EC) No
852/2004 and No 853/2004 of the European Parliament and of the Council (OJ L-139 30/04/2004) (CELEX 32004R0852)
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004R0852:EN:NOT) (CELEX 32004R0853) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004R0853:EN:NOT), respectively.
Measures in relation to the presence of residues, pesticides, veterinary medicines and contaminants in and on food.
Special provisions regarding Genetically Modified food and feed, bioproteins and novel food.
Special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs intended to
satisfy particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children).
Specific marketing and labelling requirements for feed materials, compound feedingstuffs, and feedingstuffs intended for
particular nutritional purposes.
General conditions regarding materials and articles intended to come into contact with foodstuff.
Official control to ensure compliance with the mentioned EU provisions of foodstuffs and feedingstuffs.
If a problem likely to pose a serious risk to human or animal health or to the environment appears or spreads on the territory of a
third country, the European Commission may immediately, depending on the seriousness of the situation, adopt protective
measures, laying down special conditions or suspending imports of products from all or part of the third country concerned.
European Commission, Food Safety (http://ec.europa.eu/food/safety_en):
Animal Nutrition: http://ec.europa.eu/food/safety/animal-feed_en (http://ec.europa.eu/food/safety/animal-feed_en)

General food law: http://ec.europa.eu/food/safety/general_food_law/index_en.htm
(http://ec.europa.eu/food/safety/general_food_law/index_en.htm)
Guidance Document - Key questions related to import requirements and the new rules on food hygiene and official food
controls: https://ec.europa.eu/food/sites/food/files/safety/docs/ia_ic_guidance_import-requirements.pdf
(https://ec.europa.eu/food/sites/food/files/safety/docs/ia_ic_guidance_import-requirements.pdf/)
7. Animal Health
The EU health legislation on animals and products of animal origin is aimed at protecting and raising the health status of animals (in
particular food-producing animals). Imports of animals and products of animal origin must be in accordance with the appropriate
health standards and international obligations.
Animals and products of animal origin must comply with a number of general rules, which include:
The exporting third country must be on a positive list of eligible and authorised countries to export the concerned category of
products or animals to the EU;
Products of animal origin can only be imported into de EU if they come from approved processing establishments of the
exporting third country;
Health certificates signed by an official veterinarian of the competent authority of the exporting third country will accompany
imports of animals and animal products;
Each consignment is subject to health controls at the designated Member State Border Inspection Post (BIP).
However, European authorities can take immediate action by applying temporary protective measures in the event that an
outbreak of a disease in a third country presents a serious threat to animal or public health. These measures can comprise the
suspension of imports from all or part of the territory concerned or the adoption of special conditions in respect of products from that
territory.
European Commission, Health and Consumer Protection, Animal Health and Welfare (http://ec.europa.eu/food/animals_en):
Trade and Imports of Live Animals: http://ec.europa.eu/food/animals/live_animals_en

(http://ec.europa.eu/food/animals/live_animals_en)
Trade and Imports of Products of Animal Origin: http://ec.europa.eu/food/animals/animalproducts_en

(http://ec.europa.eu/food/animals/animalproducts_en)
Trade and Imports of Semen, Ova and Embryos: http://ec.europa.eu/food/animals/semen_en
(http://ec.europa.eu/food/animals/semen_en)
General guidance on import and transit rules for live animals and animal products from third countries:
https://ec.europa.eu/food/sites/food/files/animals/docs/la_guide_thirdcountries.pdf
(https://ec.europa.eu/food/sites/food/files/animals/docs/la_guide_thirdcountries.pdf/)
8. Plant Health
The main objective of the plant health measures is to prevent the introduction and/or spread of pests and organisms harmful to
plants or plant products across the EU. Council Directive 2000/29/EC (OJ L-169 10/07/2000) (CELEX 32000L0029) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32000L0029:EN:NOT) establishes the basic legislation in this field which is
based on the principles of the International Plant Protection Convention (IPPC)-FAO Organisation (https://www.ippc.int/) and the
World Trade Organisation Agreement on Sanitary and Phytosanitary Measures
(http://www.wto.org/english/tratop_e/sps_e/sps_e.htm).
Imports of plants and plant products must comply with certain phytosanitary measures that basically require the goods to:
be accompanied by a phytosanitary certificate, issued by the designated authorities of the exporting country;
undergo customs inspections at the designated Border Inspection Post at the point of entry into the EU;
be imported into the EU by a registered importer with a Member State's official Register; and
be notified to the customs office before arrival to the point of entry.
Where consignments of plants or plant products originating in third countries, may pose a risk to the territory of the EU, Member
States or the EU itself might take temporary emergency measures
(http://ec.europa.eu/food/plant/plant_health_biosecurity/legislation/emergency_measures/index_en.htm).
Besides these mandatory provisions, the placing on the EU market of seeds and plant propagating material
(http://ec.europa.eu/food/plant/plant_propagation_material/index_en.htm) must comply with specific marketing requirements
designed to ensure that these products meet the criteria for health and high-quality. The EU legislation establishes specific
conditions for Oil and fibre plants, Cereals, Vegetables, Seed potatoes, Beet seed, Vines, Fruit plants, Fodder plants, Ornamental
plants and Forests.
Furthermore, EU legislation has also established a system for the protection of plant variety rights. On the basis of this system, a
breeder may be granted a single intellectual property right operative throughout the European Union. The Community Plant Variety
Office (CPVO) (http://www.cpvo.europa.eu/) implements and applies this system.
European Commission, Health and Food Safety, Plant Protection:

http://ec.europa.eu/food/plant/plant_health_biosafety/index_en.htm
(http://ec.europa.eu/food/plant/plant_health_biosafety/index_en.htm)
9. Public Health
The European Union has the duty of ensuring a high level of human health protection as laid down in the European treaties.
The public health framework contains the measures taken both at the level of the Member States and of the EU, designed to
confront major health threats:
Monitoring and control of communicable diseases (http://ec.europa.eu/health/communicable_diseases/policy/index_en.htm),

such as the Severe Acute Respiratory Syndrome (SARS) (http://ec.europa.eu/research/health/infectious-diseases/emerging-
epidemics/projects/159_en.html) and pandemic influenza
(http://ec.europa.eu/health/communicable_diseases/diseases/influenza/h1n1/index_en.htm), in order to prevent their spread.
Control policy of health problems related to unhealthy lifestyles, such as tobacco,
(http://ec.europa.eu/health/tobacco/policy/index_en.htm) and/or drugs and substances
European Commission, Health and Food Safety, Public Health:

http://ec.europa.eu/health/index_en.htm (http://ec.europa.eu/health/index_en.htm)
In addition, Council Regulation (EC) No 111/2005 (OJ L-22 26/01/2005) (CELEX 32005R0111) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32005R0111:EN:NOT) sets up rules for the monitoring of trade in drug
precursors with the purpose of avoiding the illicit use of certain chemical substances in the manufacture of narcotic drugs and
psychotropic substances.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Drug

precursors:http://ec.europa.eu/growth/sectors/chemicals/legislation/index_en.htm
(http://ec.europa.eu/growth/sectors/chemicals/legislation/index_en.htm)
European Commission, Taxation and Customs Union, Drug precursors control:

http://ec.europa.eu/taxation_customs/customs/customs_controls/drugs_precursors/index_en.htm
(http://ec.europa.eu/taxation_customs/customs/customs_controls/drugs_precursors/index_en.htm)
10. Environment Protection

Environment is one of the European Union top priorities. Therefore, all relevant EU policies (e.g. agriculture, development, energy,
fisheries, industry, transport) do take into account the impact they will have on the environment.
The EU environmental keystone is the Seventh Environment Action Programme

(http://ec.europa.eu/environment/newprg/index.htm), which covers the period from 2013 to 2020. It is mainly focused on four areas:
climate change; nature and biodiversity; environment and health; and sustainable management of natural resources and waste.
Some of the policy areas are grouped in the following environmental themes:
A. Chemicals
European Commission, Environment, Chemicals:
http://ec.europa.eu/environment/chemicals/index.htm (http://ec.europa.eu/environment/chemicals/index.htm)
Control of trade in Dangerous Chemicals

Imports of certain dangerous chemicals into the European Union are subject to control measures laid down by Regulation (EU) No
649/2012 of the European Parliament and of the Council (OJ L-201 27/07/2012) (CELEX 32012R0649) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32012R0649:EN:NOT) which implements the Rotterdam Convention
(http://www.pic.int/) on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international
trade.
All information regarding import requirements is contained in Chemicals subject to PIC (http://www.echa.europa.eu/information-on-
chemicals/pic/chemicals) in the European Chemicals Agency (ECHA) website.
European Commission, Environment, Trade of Dangerous Chemicals:

http://ec.europa.eu/environment/chemicals/trade_dangerous/index_en.htm
(http://ec.europa.eu/environment/chemicals/trade_dangerous/index_en.htm)
Control of Persistent Organic Pollutants (POPs)

Imports of persistent organic pollutants (POPs) into the EU are subject to control measures which aim at eliminating or minimising
the use of these products. Thus, Regulation (EU) 2019/1021 of the European Parliament and of the Council (OJ L-169 25/06/2019)
(CELEX 32019R1021) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32019R1021:EN:NOT) implements the
provisions laid down by the Stockholm Convention (http://chm.pops.int/) on POPs and the Protocol to the regional UNECE
Convention on Long-Range Transboundary Air Pollution (CLRTAP) (http://www.unece.org/env/lrtap/pops_h1.htm).
European Commission, Environment, POPs - Persistent Organic Pollutants:

http://ec.europa.eu/environment/chemicals/international_conventions/index_en.htm
(http://ec.europa.eu/environment/chemicals/international_conventions/index_en.htm)
Registration, Evaluation, Authorisation and Restriction of Chemicals

(REACH)
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907:EN:NOT) concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) was adopted in December 2006.
In principle it applies to all chemicals: not only to those used in industrial processes, but also in our everyday life, for example in
cleaning products, paints, etc. as well as in articles such as clothing, furniture and electrical appliances.
The REACH Regulation replaces several EU laws related to chemicals and it is complementary to other environmental and safety
legislation. However, it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.)
The European Chemicals Agency (ECHA) (http://www.echa.europa.eu/) is the central point in the REACH system. The Agency will
manage and coordinate the registration, evaluation, authorisation and restriction processes of chemical substances to ensure
consistency in the management of chemicals across the European Union.
Classification, Labelling and Packaging (CLP) of substances and mixtures

Additionally, prior to the placement of chemicals in the EU market, they have to be classified, labelled and packaged in accordance
with the Regulation (EC) No 1272/2008.
This Regulation introduces a new system based on the United Nations Globally Harmonised System (GHS)
(http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html) which sets up the classification of chemicals according to their
hazardous properties. It also defines the pictograms and other notices which must appear on the labels of such substances.
This Regulation will gradually replace currently applicable legislation in a stepwise approach until 2015.
Further information is available at the European Chemicals Agency (ECHA) - CLP website:
https://www.echa.europa.eu/web/guest/regulations/clp/understanding-clp
(https://www.echa.europa.eu/web/guest/regulations/clp/understanding-clp)
Plant protection products and biocidal products

(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32009R1107:EN:NOT) lays down the conditions for the
authorisation of plant protection products in commercial form and/or the approval of active substances, safeners and synergists,
which these products contain or consist of, as well as the rules for their placing on the market, use and control within EU.
European Commission, Health and Food Safety, Plant protection products:

http://ec.europa.eu/food/plant/plant_protection_products/index_en.htm
(http://ec.europa.eu/food/plant/plant_protection_products/index_en.htm)
On the other hand, the placing on the EU market of biocidal products (i.e. disinfectants used in different areas, chemicals used for
preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels are subject to
the requirements established in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L-167
27/06/2012) (CELEX 32012R0528) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32012R0528:EN:NOT).
Detergents
Detergents and surfactants for detergents must comply with provisions on biodegradability and labelling laid down in Regulation
(EC) No 648/2004 of the European Parliament and of the Council (OJ L-104 08/04/2004) (CELEX 32004R0648) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004R0648:EN:NOT) designed to ensure a high level of environmental
protection, especially of the aquatic environment, and of human health.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Detergents:

http://ec.europa.eu/growth/sectors/chemicals/legislation/index_en.htm
Fertilisers
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003R2003:EN:NOT) includes the provisions relating to the
placing of fertilisers in the EU market, i.e. the conditions for designating 'EC fertilisers', as well as the provisions regarding their
labelling and packaging.
European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Fertilisers:

http://ec.europa.eu/growth/sectors/chemicals/legislation/index_en.htm
B. Ozone-Depleting Substances (ODS)

Imports of ozone-depleting substances (ODS) are only authorised to enter the EU under certain conditions, in accordance with the
provisions of 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) (CELEX 32009R1005) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=CELEX:32009R1005:EN:NOT): they must be subject to essential or critical uses, must be originated from a third country party
to the 1987 Montreal Protocol on ODS (http://ozone.unep.org/Ratification_status/), and must be accompanied by an import licence
issued by the EU Directorate-General for Environment according to annually approved quotas.
Moreover, imports of products and equipment containing or relying on ODS are prohibited.
European Commission, Environment, Ozone Layer Protection:

http://ec.europa.eu/clima/policies/ozone/index_en.htm (http://ec.europa.eu/clima/policies/ozone/index_en.htm)
C. Fluorinated Greenhouse Gases

The objective of the European Commission is to reduce emissions of fluorinated greenhouse gases covered by the Kyoto Protocol.
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R0842:EN:NOT) provides for better containment and
recovery; training and certification of personnel involved; reporting of production, import and export data, labelling of certain
products and equipment containing those gases. Where containment and recovery is impracticable, there is a marketing prohibition.
European Commission, Environment, Fluorinated greenhouse gases:

http://ec.europa.eu/clima/policies/f-gas/index_en.htm (http://ec.europa.eu/clima/policies/f-gas/index_en.htm)
D. Endangered Species protection (CITES)

Wildlife regulatory measures in the EU are based on the 1973 Convention on International Trade in Endangered Species of Wild
Fauna and Flora (CITES) (http://www.cites.org/) which is meant to ensure that international trade in these animals and plants is not
a threat to their conservation.
Council Regulation (EC) No 338/97 (OJ L-61 03/03/1997) (CELEX 31997R0338) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997R0338:EN:NOT) establishes a system of permits and certificates that
must be obtained before the importation of specimens (or parts or derivatives made thereof) can take place.
European Commission, Environment, CITES:

http://ec.europa.eu/environment/cites/home_en.htm (http://ec.europa.eu/environment/cites/home_en.htm)
E. Control and management of Waste

The obligations for the management, recovery and correct disposal of waste (for instance, compulsory approval or registration for
business operators in the Member States) are laid out in Directive 2008/98/EC.
Further information is available at: http://ec.europa.eu/environment/waste/index.htm

(http://ec.europa.eu/environment/waste/index.htm)
Referenced legislation: Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste (OJ L-
312 22/11/2008) (CELEX 32008L0098) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008L0098:EN:NOT)
Shipment of waste
Waste introduced into the territory of the EU is subject to the control measures laid down by Regulation (EC) No 1013/2006 of the
European Parliament and of the Council (OJ L-190 12/07/2006) (CELEX 32006R1013) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1013:EN:NOT) on shipments of waste. This Regulation establishes a
system of prior authorisation and compulsory notification for the shipment of waste.
Besides, the EU legislation has also established a specific system of prior authorisation for shipments of radioactive waste in order
to provide greater protection against the dangers of ionising radiation.
European Commission, Environment, Shipment of Waste:

http://ec.europa.eu/environment/waste/shipments/index.htm (http://ec.europa.eu/environment/waste/shipments/index.htm)
Packaging waste
In order to prevent and minimise the environmental problems associated with packaging waste, Directive 94/62/EC of the European
Parliament and of the Council (OJ L-368 31/12/1994) (CELEX 31994L0062) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=CELEX:31994L0062:EN:NOT) lays down essential requirements as to the composition and the recoverable nature of all
packaging placed on the EU market:
Packaging must be of minimal value and weight in order to maintain the necessary level of safety, hygiene and acceptance for
the product and for the consumer;
Hazardous substances in packaging shall be minimised and concentration of heavy metals shall not exceed a certain level;
Packaging shall be suitable for reuse, recovery and recycling.
To facilitate collection, reuse and recovery, packaging shall indicate for purposes of its identification and classification by the
industry concerned the nature of the packaging material(s) used. Packaging shall bear the appropriate marking.
European Commission, Environment, Packaging Waste:

http://ec.europa.eu/environment/waste/packaging_index.htm (http://ec.europa.eu/environment/waste/packaging_index.htm)
Waste Electrical and Electronic Equipment (WEEE)

Directive 2011/65/EU of the European Parliament and of the Council (OJ L-174 01/07/2011) (CELEX 32011L0065) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32011L0065:EN:NOT) on the restriction of the use of certain hazardous
substances in electrical and electronic equipment and Directive 2002/96/EC of the European Parliament and of the Council (OJ L-
37 13/02/2003) (CELEX 32002L0096) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32002L0096:EN:NOT) on

waste electrical and electronic equipment aim to prevent the production and disposal of hazardous waste and to promote reuse,
recycling and other forms of recovery of such waste.
European Commission, Environment, Waste Electrical and Electronic Equipment:

http://ec.europa.eu/environment/waste/weee/index_en.htm (http://ec.europa.eu/environment/waste/weee/index_en.htm)
Batteries and Accumulators

Directive 2006/66/EC of the European Parliament and of the Council (OJ L-266 26/09/2006) (CELEX 32006L0066) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006L0066:EN:NOT) on batteries and accumulators and waste batteries and
accumulators prohibits the marketing of batteries containing hazardous substances and establishes schemes for collection and
recycling.
European Commission, Environment, Batteries:

http://ec.europa.eu/environment/waste/batteries/index.htm (http://ec.europa.eu/environment/waste/batteries/index.htm)
11. Marketing standards for agricultural and fishery products

Marketing standards have been laid down in the EU mainly for agricultural and fishery products which are supplied fresh to the
consumer, with a view to guarantee the same level of quality for all products placed on the EU market.
Council Regulation (EU) No 1308/2013 (OJ L-347 20/12/2013) (CELEX 32013R1308) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32013R1308:EN:NOT) establishes a common marketing system for all the
agricultural products concerned that may vary in order to take account of the particularities of each product related to different
aspects: freshness, size, quality, presentation, tolerances, etc.
Council Regulation (EC) No 2406/96 (OJ L-334 23/12/1996) (CELEX 31996R2406) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31996R2406:EN:NOT) lays down common marketing standards for certain
fishery products. The marketing standards may cover classification by quality, size or weight, packing, presentation and labelling.
Member States are responsible for ensuring that the imported agricultural and fishery products comply with these marketing
standards through documental and/or physical inspections.
European Commission, Agriculture and Rural Development, Agricultural Markets:

http://ec.europa.eu/agriculture/markets/index_en.htm (http://ec.europa.eu/agriculture/markets/index_en.htm)
Products from organic production

Organic production is a voluntary scheme aimed at guaranteeing that agricultural products are produced in accordance with certain
production methods laid down by Council Regulation (EC) No 834/2007 (OJ L-189 20/07/2007) (CELEX 32007R0834) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32007R0834:EN:NOT) on Organic Farming. The aim of organic standards is
the integration of environmental conservation into agriculture and the promotion of quality products.
Products complying with EU rules are allowed to bear the EU organic farming logo, which assures consumers that the product has
been manufactured according to organic standards.
The production and placement of organic products with labels and logos on the EU market follows a strict certification process that
must be complied with.
European Commission, Agriculture and Rural Development, Organic Farming:

https://ec.europa.eu/agriculture/organic/index_en (https://ec.europa.eu/agriculture/organic/index_en)
12. Product Safety
The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Directive
2001/95/EC of the European Parliament and of the Council (OJ L-11 15/01/2002) (CELEX 32001L0095) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0095:EN:NOT) on the General Product Safety.
The following obligations are imposed to manufacturers and distributors:
To supply products that comply with the general safety requirements;

To inform consumers of the risks that a product might pose and of the precautions they should take;
To notify to the appointed authorities in Member States if they discover that a product is dangerous and cooperate with them
on the action taken to avoid the risks for consumers
Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support
of certain mechanisms established at EU level, particularly the Rapid exchange of information between Member States and the
European Commission on products causing serious risks, called RAPEX-System.
The General Product Safety Directive applies in a complementary way to products covered by specific sector legislation such as:
Cosmetics (http://ec.europa.eu/growth/sectors/cosmetics_en)
Pharmaceuticals
Medicinal products for human use (http://ec.europa.eu/health/human-use/index_en.htm)
Medicinal products for veterinary use (http://ec.europa.eu/health/veterinary-use/index_en.htm)
Industrial products (http://ec.europa.eu/growth/sectors_en) (chemicals, medical devices, electric equipment, machinery,
vehicles, personal protective equipment, etc.)
Liability for defective products (https://ec.europa.eu/growth/single-market/goods/free-movement-sectors/liability-defective-
products_en)
In addition, the General Product Safety Directive is complemented by the Council Directive 87/357/EEC (OJ L-192 11/07/1987)
(CELEX 31987L0357) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31987L0357:EN:NOT) concerning products
which, appearing to be other than they are, endanger the health or safety of consumers.
This Directive applies to products which are not edible but could easily be confused with foodstuffs by their appearance, smell or
packaging. Member States must take all the necessary measures to prohibit the marketing, import and manufacture of such
products. Checks must be carried out to ensure that no such products are marketed. If a Member State bans a product under the
terms of this Directive it must inform the European Commission and provide the details needed to inform the other Member States.
European Commission:
The General Product Safety Directive:

http://ec.europa.eu/consumers/consumers_safety/product_safety_legislation/general_product_safety_directive/index_en.htm
(http://ec.europa.eu/consumers/consumers_safety/product_safety_legislation/general_product_safety_directive/index_en.htm)
Sector-specific legislation: http://ec.europa.eu/consumers/consumers_safety/product_safety_legislation/index_en.htm
(http://ec.europa.eu/consumers/consumers_safety/product_safety_legislation/index_en.htm)
Rapid Alert System for non-food consumer products (RAPEX):
http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/index_en.htm
(http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/index_en.htm)
13. Technical Standardisation

The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical
standards in the Member States.
New approach and Global Approach Directives vs. Old Approach Directives
Council Resolution of 7 May 1985 (OJ C-136 04/06/1985) laid down a new approach to technical harmonisation and standards, with
three main objectives:
the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as
well as types of hazard
the setting up of appropriate conformity assessment procedures
the introduction of CE marking
New Approach Directives set down general health and safety requirements, as well as specifications for meeting these general
requirements are found in the standards applicable to each product.
Global Approach Directives lay down the guiding principles for Community policy on conformity assessment procedures (the
system and responsibilities for testing and certification and, where applicable, accredited test laboratories).
This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical
and detailed product-specific directives which were difficult to implement (Old Approach Directives). However, certain groups of
products are still covered by Old Approach Directives: foodstuffs, motor vehicles, chemicals, cosmetics, detergents, biocides and
pharmaceutical sectors.
New approach principles

The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are
placed on the EU market (such as health, safety, consumer protection and environmental protection)
The technical specifications of products meeting the essential requirements may be laid down in harmonised standards
drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN) (http://www.cen.eu),
European Committee for Electrotechnical Standardisation (CENELEC) (http://www.cenelec.eu/) and European
Telecommunications Standards Institute (ETSI) (http://www.etsi.org/)
The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in
compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential
requirements
Each Member State has designated notified bodies in charge of the conformity assessment procedures when a third party is
required.
European Commission, Enterprise and Industry, New Approach, NANDO:

http://ec.europa.eu/enterprise/newapproach/nando/ (http://ec.europa.eu/enterprise/newapproach/nando/)
Global approach and Conformity assessment procedure

Global approach Directives establish a range of procedures for assessing the conformity of products to the essential requirements
laid down by the technical harmonisation directives.
Conformity assessment is either carried out by the manufacturer or by a third party (notified body) and relates to the design phase
of products, their production phase or both.
There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full
quality assurance, etc.
Council Resolution of 21 December 1989 (OJ C-010 16/01/1990) sets up guiding principles for a reliable EU policy on conformity
assessment, such as:
Generalised use of the European standards relating to quality assurance

Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical
development and have a compatible approach concerning conformity assessment
The 'CE marking of conformity
Most New Approach Directives provide for the affixing of the CE marking, which indicates that the product complies with the
essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment
procedure. The CE marking:
has a single form consisting of the 'CE' marking and of the identification number of the notified body involved in the production
control phase when a third party is required
is affixed to the product itself, to its packaging or to the accompanying document;
enables the product in question to be placed on the EU market.
Market surveillance
Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements
and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical
inspections.
Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are
responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required
conformity assessment procedure.
Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not
accompanied by the required documentation.
New Internal Market Package for Goods

A New Legal Framework for the modernisation of the New Approach has been adopted in the following package of measures:
Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating
to the application of certain national technical rules to products lawfully marketed in another Member State and repealing
Decision No 3052/95/EC (OJ L-218 13/08/2008) (CELEX 32008R0764) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=CELEX:32008R0764:EN:NOT) (applicable from 13 May 2009)
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for
accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L-
218 13/08/2008) (CELEX 32008R0765) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=CELEX:32008R0765:EN:NOT) (applicable from 1 January 2010)
Decision 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the
marketing of products, and repealing Council Decision 93/465/EEC (OJ L-218 13/08/2008)
This new proposal aims at removing the remaining obstacles to free circulation of products and ensuring that only safe products
circulate around all over the EU market. In this sense, market surveillance structures as well as testing, certification procedures, as
well as inspection bodies accreditation shall be reinforced.
European Commission, Enterprise and Industry, New Approach:

http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/market-
surveillance/index_en.htm (http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/market-
surveillance/index_en.htm)
14. Packaging
Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as
with the specific provisions designed to prevent any risk to the health of consumers, for example:
Recycling materials, packaging waste prevention,

Size, nominal quantities and capacities,
Composition and constituents of materials intended to come into contact with foodstuffs
Hence, these types of products are affected by:
General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC of the European Parliament
and of the Council (OJ L-365 31/12/1994) (CELEX 31994L0062) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=CELEX:31994L0062:EN:NOT);
Specific provisions related to package sizing, established in Council Directive 75/106/EEC (OJ L-42 15/02/1975) (CELEX
31975L0106) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31975L0106:EN:NOT) and Council Directive
80/232/EEC (OJ L-51 25/02/1980) (CELEX 31980L0232) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=CELEX:31980L0232:EN:NOT);
Specific rules on nominal quantities for prepacked products, set out by Directive 2007/45/EC of the European Parliament and
of the Council (OJ L-247 21/09/2007) (CELEX 32007L0045) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=CELEX:32007L0045:EN:NOT)
Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) No
1935/2004 of the European Parliament and of the Council (OJ L-338 13/11/2004) (CELEX 32004R1935) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004R1935:EN:NOT).
Besides these mandatory provisions, imports into the EU of packaging made of wood and other plant products may be subject to
phytosanitary measures established by Council Directive 2000/29/EC (OJ L-169 10/07/2000) (CELEX 32000L0029) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32000L0029:EN:NOT).
In relation to wood packaging, the provisions introduced by Commission Directive 2004/102/EC (OJ L-309 06/10/2004) (CELEX
32004L0102) (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004L0102:EN:NOT) establish that wood packages
of any type (cases, boxes, crates, drums, pallets, box pallets and other load boards, pallet collars, etc.) shall go through one of the
approved treatments specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear the
corresponding mark as specified in Annex II.
European Commission, Health and Food Safety, Plant Protection: An overview of EU rules on wood packaging material:
http://ec.europa.eu/food/plant/organisms/imports/overview_eu_rules.pdf
(http://ec.europa.eu/food/plant/organisms/imports/overview_eu_rules.pdf/)
15. Labelling
1. Labelling requirements
In view of consumers protection, only products which comply with the EU labelling requirements may be marketed within the EU.
The aim of the labelling requirements is to ensure a high level of protection of consumers' health, safety and interests, providing
information on the product related to content, composition, safe use and special precautions, other specific details, etc.
The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances,
footwear, textiles, etc.
European Union, Summaries of Legislation, Product Labelling and Packaging:

http://eur-lex.europa.eu/summary/chapter/consumers.html?
root_default=SUM_1_CODED%3D09%2CSUM_2_CODED%3D0905&obsolete=true&locale=en (http://eur-
lex.europa.eu/summary/chapter/consumers.html?
root_default=SUM_1_CODED%3D09%2CSUM_2_CODED%3D0905&obsolete=true&locale=en)
2. EU Eco-label
The EU Eco-label or 'Flower logo' is a voluntary scheme that may be awarded to products which contribute significantly to
improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the
environmental impact of products. The basic rules for Eco-labelling are established in Regulation (EC) No 66/2010 of the European
Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L-27 30/01/2010) (CELEX 32010R0066) (http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32010R0066:EN:NOT).
Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products,
household appliances, paper products, etc).
The Flower logo can be displayed as a marketing tool to show consumers that the product has a superior environmental quality
when comparing it with other products of the same group.
Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member
State in which the product has been placed on the market.
European Commission, Environment, Eco-label:

http://ec.europa.eu/environment/ecolabel/index_en.htm (http://ec.europa.eu/environment/ecolabel/index_en.htm)
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21/5/2020 Mi exportación | Trade Helpdesk

Fecha de última revisión (dd / mm / aaaa): 01/03/2020

Unión Europea - Resumen de los procedimientos de importación

- el territorio del principado de Mónaco

Código aduanero de la Unión (UCC)

(http://ec.europa.eu/taxation_customs/customs/procedural_aspects/general/community_code/index_en.htm) . Este Código,

Declaración resumida de entrada

1. Despacho a libre práctica

Tránsito , que comprende el tránsito externo e interno:

Storage, which comprises customs warehousing and free zones:

Specific use, which comprises temporary admission and end-use:

Processing, which comprises inward and outward processing:

European Commission, Taxation and Customs Union, UCC Guidance documents:

Customs declaration - SAD (Single Administrative Document)

The SAD may be presented either by:

Value for Customs purposes

European Commission, Taxation and Customs Union, Value of Declared Goods:

The free movement of goods within the EU is achieved through:

The principle of non-discrimination.

The mutual recognition principle.

European Union, Summaries of Legislation, European Community legal instruments:

4. Product Classification in Tariff Nomenclatures

Harmonised System, Combined Nomenclature and Taric Code

- Optical, photographic, cinematographic, measuring, checking, precision, medical or

5. Import Trade Regime

Import restrictions are implemented in the following sectors:

European Commission, Trade, Agricultural Policy and Trade:

European Commission, Trade, Textile sector:

C. Iron, Steel and Aluminium Products

European Commission, Trade, Steel sector:

6. Food and Feed Safety

European Commission, Food Safety (http://ec.europa.eu/food/safety_en):

Animal Nutrition: http://ec.europa.eu/food/safety/animal-feed_en (http://ec.europa.eu/food/safety/animal-feed_en)

Trade and Imports of Live Animals: http://ec.europa.eu/food/animals/live_animals_en

Trade and Imports of Products of Animal Origin: http://ec.europa.eu/food/animals/animalproducts_en

European Commission, Health and Food Safety, Plant Protection:

Monitoring and control of communicable diseases (http://ec.europa.eu/health/communicable_diseases/policy/index_en.htm),

European Commission, Health and Food Safety, Public Health:

European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Drug

European Commission, Taxation and Customs Union, Drug precursors control:

10. Environment Protection

The EU environmental keystone is the Seventh Environment Action Programme

Control of trade in Dangerous Chemicals

European Commission, Environment, Trade of Dangerous Chemicals:

Control of Persistent Organic Pollutants (POPs)

European Commission, Environment, POPs - Persistent Organic Pollutants:

Registration, Evaluation, Authorisation and Restriction of Chemicals

Classification, Labelling and Packaging (CLP) of substances and mixtures

Plant protection products and biocidal products

European Commission, Health and Food Safety, Plant protection products:

European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Detergents:

European Commission, Internal Market, Industry, Entrepreneurship and SMEs, Fertilisers:

B. Ozone-Depleting Substances (ODS)

European Commission, Environment, Ozone Layer Protection:

C. Fluorinated Greenhouse Gases

European Commission, Environment, Fluorinated greenhouse gases:

D. Endangered Species protection (CITES)

European Commission, Environment, CITES:

E. Control and management of Waste

Further information is available at: http://ec.europa.eu/environment/waste/index.htm

European Commission, Environment, Shipment of Waste:

European Commission, Environment, Packaging Waste: