The European Community require certain standards on product safety for certain types of goods. The range of products covered by the directives must comply with the applicable directives when it is placed on the community market for the first time or put into use. Placing on the market in the meaning of the directives is the action of making a product available for the first time, either for payment or free of charge. 'Putting into service' takes place at the moment of first use within the Community by the end user (for example, produced for own use of the importer).
Range of products
The most important products are toys, in-vitro diagnostic medical devices, medical devices, machinery, low voltage equipment, safety devices (for example, helmets), exhaust systems and electromagnetic compatibility. For a full overview please see the EU website: http://www.newapproach.org/Directives/DirectiveList.asp
Responsibilities
Manufacturers are defined as the persons responsible for designing and manufacturing products supposed to be placed on the EU market. The manufacturer has an obligation to ensure that a product intended to be placed on the Community market is designed and manufactured, and it's conformity assessed, to the essential requirements in accordance with the provisions of the directives. The manufacturer may appoint any natural or legal person, established in the European Union, to act on his behalf as an authorized representative.
The authorized representative may be addressed by the authorities of the member states in regard to the manufacturer's obligations.
The importer is defined as any legal or natural person responsible for placing products on the EU market. He is responsible to provide the market surveillance authority with the necessary information about the safety of the product and a copy of the Declaration of Conformity (DoC). If the manufacturer is established in the EU or has a so called authorized representative it is his obligation to provide the necessary information.
Conformity Assessment Procedure
Goods subject to the regulations on product safety need to be tested according to the rules applying for each group of products. Manufacturers have to draw up an EC Declaration of Conformity which is the first step of the conformity assessment procedure. The declaration of conformity has to include technical information containing the way of testing and the steps to be taken to obtain the attestation of conformity. The way of testing and steps to be taken depends on the type of product. If the testing was successful the producer is allowed to apply the so called 'CE sign' on the product or where this is not applicable (for example, surgical instruments) at the retail package or on a "Declaration of Conformity" certificate.
The "Declaration of Conformity" has to be issued by a notified body certified by a member state of the European Union.
Notified Body
A notified body is an organization certified by the national government to carry out the tasks of the conformity assessment procedures. They can offer their service to any economic operator inside and outside the European Community. They can carry out the tests or monitor the tests carried out by the manufacturer. They can carry out these activities inside the EU or on the territory of third countries or territories.
Information about notified bodies and notified bodies itself can be found on the EU website: http://ec.europa.eu/enterprise/newapproach/nando
For additional information, please also refer to "Product Safety".
An exporter who wants his products to benefit from the preferential treatment must be able to prove that his products fulfill the rules to be originating in a country or territory covered by the preferential trade agreement and they must provide a preferential document validated by the customs authorities or document with a valid preferential statement issued by themselves.
The preferential trade agreement foresees the following preferential proofs under CETA-see Miscellaneous.
All exporters of consignments of goods with a value greater than 6000 EUR to Canada must be registered in the Registered Exporters System (REX). If you register and are exporting consignments of goods with a value greater than 6000 EUR to Canada you can avail of preferences under CETA. To register you should register complete the EU exporters to Canada application form and send it to the Origin and Valuation Unit.
Exporters must use their REX number on the origin declaration to claim preference under CETA. If you are importing from Canada, you can qualify under CETA for preferences, but you do not have to register in REX.
The origin declaration, the text of which is given below, must be completed in accordance with the footnotes. However, the footnotes do not have to be reproduced.
(Period: from___________ to __________(1)) The exporter of the products covered by this document (customs authorization No ...(2)) declares that, except where otherwise clearly indicated, these products are of ...(3) preferential origin. ..(4) (Place and date) .(5) Signature and printed name of the exporter)__________________
(1) When the origin declaration is completed for multiple shipments of identical originating products within the meaning of Article 19.5, indicate the period of time for which the origin declaration will apply. The period of time must not exceed 12 months. All importations of the product must occur within the period indicated. Where a period of time is not applicable, the field can be left blank.
(2) For EU exporters: When the origin declaration is completed by an approved or registered exporter the exporter's customs authorization or registration number must be included. A customs authorization number is required only if the exporter is an approved exporter. When the origin declaration is not completed by an approved or registered exporter, the words in brackets must be omitted or the space left blank. For Canadian exporters: The exporter's Business Number assigned by the Government of Canada must be included. Where the exporter has not been assigned a business number, the field may be left blank.
(3) "Canada/EU" means products qualifying as originating under the rules of origin of the Canada-European Union Comprehensive Economic and Trade Agreement. When the origin declaration relates, in whole or in part, to products originating in Ceuta and Melilla, the exporter must clearly indicate the symbol "CM".
(4) These indications may be omitted if the information is contained on the document itself.
(5) Article 19.3 provides an exception to the requirement of the exporter's signature. Where the exporter is not required to sign, the exemption of signature also implies the exemption of the name of the signatory.
The European Commission provides detailed guidance on the rules of origin in the EU-Canada Comprehensive Economic and Trade Agreement (CETA)
It is not required for all, however shipments can be held by local authority in United Arab Emirates after screening due to lack of MSDS (Material Safety Data Sheet) or NON DG (Dangerous Goods) declaration letter from the shipper resulting to misconnections and impacting end-to-end service.
It would be advisable for all shipments originating, transiting and terminating for UAE to have MSDS or NON DG declaration from shipper enclosed in the shipment and copies to be uploaded in IDIS.
Market Surveillance is organized and performed at national level. Each member state of the European Union [EU] is responsible for surveillance activities on its territory. Customs authorities are usually part of the market surveillance activities.
On customs request the Declaration of Conformity (DoC) has to be provided by the shipper, the manufacturer or his assigned representative in the EU or the importer.
Declaration of Conformity
The Declaration of Conformity (DoC) is a document in which the manufacturer, or his authorized representative within the EU, indicates that the product meets all the necessary requirements of the directives applicable for the specific product. The DoC shall contain the name and the address of the manufacturer along with information about the product (e.g. brand and serial number). The DoC must be signed by an individual working for the manufacturer or his authorised representative.
On request, the manufacturer or his authorized representative within the EU must provide the DoC. In case the manufacturer is not an EU entity and does not have an authorized representative, the importer must be able to provide a copy of the DoC and additional proofs; if requested.
For every formal customs declaration, the identification number of the importer is mandatory. The identification number used in the European Union is called the EORI number (Economic Operators Registration and Identification System). Everyone can apply for an EORI number. The application form can be found on the customs website: www.carina.hr
Every declaration without the EORI number of the importer will be rejected by customs if the importer is a company or a regular importer. The declaration can be lodged with the copy of a signed application form if the importer does not apply for the EORI number prior to arrival of the shipment.
Please note that not only the value(s) of the commodity/commodities have to be considered when calculating duty and tax, but also the freight charge and other fees.
There are special stipulations on the following commodities when shipping to Croatia. If you plan to ship one of the commodities listed below, be sure to adhere to the following stipulations in order to avoid delays and holds at customs.
An Import License is required for commercial shipments of medicine. The Prescription has to accompany the package. However, it is not required to be on the outside of the package. It is acceptable to be included inside the package.
A veterinarian inspection or a Health Certificate may be required to import processed food depending on the percentage of animal products contained. A veterinarian determines the requirements for an inspection or Health Certificate based on the percentage of egg, meat, fish, milk, and milk products (especially cheese). The percentages of egg, milk, milk products, fish and meat should be stated on the invoice to support customs clearance.
Brokerage accessorial charges will apply and an import delay may occur.
Based on the EU regulation 2009/669/EC certain foodstuffs (for example tea with origin China) imported from certain third countries or territories are subject to increased level of official controls due to contamination risks of these products by aflatoxinson and pathogens. These controls are carried out at Designated Point of Entries (DPE) defined by each member state.
The import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station and not subject to vet inspection can only be imported into the EU through Designated Point of Entries (DPE). They must be accompanied by a declaration attesting that the goods are either harvested or processed before March 11, 2011, originated from a prefecture other than the ones affected by higher levels of radiation or if originated from an affected prefecture have been subjected to laboratory analysis determining the level of certain radionuclides (regulation 2011/297/EC).
The customs office responsible for our import sites are not defined as DPE. Commodities subject to import controls at a DPE cannot be imported with UPS.
Private Individuals are not allowed to import shipments containing medicine of any kind or value into Croatia.
The European Union (EU) has implemented specific conditions and detailed procedures for the import of plastic kitchenware (HS-Code 3924 1000 11) made of polyamide and melamine and originated in or consigned from China or Hong Kong (regulation 284/2011). Tableware (for example, plates, flatware, cups) are excluded from the restrictions. The reason for the new regulation were notifications and alerts by the European 'Rapid Alert System'- kitchen tableware was recognized which exceed the thresholds of aromatic amines and formaldehyde released into food.
Based on the regulation, controls must be performed at the point of introduction into the EU by the competent authorities. They include documentary checks on all consignments and identity or physical checks (including laboratory checks) on 10% of the consignments. All consignments of kitchen tableware (HS code 3924 1000) originated or consigned from China or Hong Kong must be accompanied by a declaration confirming that it meets the requirements concerning the release of primary aromatic amines and formaldehyde. The declaration shall be accompanied by a laboratory report that the consignments fulfill the requirements.
The goods and declaration must be examined at the first point of introduction into the EU.
The consignments shall be notified at the first point of introduction at least two working days in advance.
Our main points of entry (Cologne, Germany and East Midlands, United Kingdom) are not competent to perform the checks and forwarding under bond is prohibited without the checks. Products covered by the new regulation and destined to the EU can't be accepted by UPS. Exporters should clearly state on the invoice the material and the country or territory of origin of plastic kitchenware to avoid holds on commodities not subject to the regulation.
Monoclonal antibodies are generated in vitro. Tissue from animals are taken (e.g. blood) and infected with certain substances or pathogens. The blood cells react with the production of antibodies which are than harvested and used for the production of the test kits. Due to the in vitro production and the controlled way of production those types of test kits are not subject to veterinarian control if it is a commercial production.
Polyclonal antibodies are gained from living animals like rabbits. They are infected with the substances / pathogens and the animals are producing antibodies. The antibodies are harvested from the blood stream of the animals. Test reagents with polyclonal antibodies are subject to vet inspections.
Shipment documents (commercial invoice or declaration on letterhead) should include:
the place of origin of the material
the quantity of the material, in weight or volume
a description of the material/ animal source
catalogue number and price (if available)
additives (e.g., sodium azide, glycerol), their source (e.g., whole serum, supernatant, ascites), and purification, if any.
protocols the recommended protocol or datasheet indicating any unique fixation, detergent, blocking, or incubation conditions.
the intended use (commercial/ manufacturing; research/ testing)
the name and address of the shipper
the name and address of the receiver
Commercially packaged, ready-to-use In Vitro Diagnostics (IVD) containing products of animal of origin, do not require a Vet-inspection, if compliant with Directive 98/79/EC on In Vitro Diagnostic Medical Devices. A declaration of conformity (CE-marking) must be provided for each individual commodity (e.g. reagents, test kits, immunosorbent assays such as ELISA kits).
If the valued of the shipment exceeds the gift limit, Customs clears the shipment as a non-gift shipment.
In addition to a detailed description of each item, write additional comments of "gift shipment" on the invoice and in the Special Instructions box of the UPS Waybill to insure a proper assessment of duties and taxes.
Customs does not accept photocopies or fax copies of invoices.
Shipments of documents do not require an invoice.
The consignee's telephone number, mobile number and email address, if available, should appear on the invoice.
Incoterms
Paperless Invoice - Imports
UPS Paperless Invoice is accepted by Customs for small package imports into this country or territory.
Software on CD-s, DVDs or similar media
Invoices should state the value of the media and the value of the software (intellectual value) separately. Only VAT apply on the value of the software (intellectual value). For updates of already imported software only the media is dutiable if the updates are free of charge. The updates of any software (if not being paid for) can be considered as non dutiable. If an invoice is sent with a shipment for an update of software it should be listed on invoice as free of charge and a gratis invoice should be included. Importer should provide the gratis statement to explain the purpose of the import. If the value of the media and the software are not seperated on the invoice duty and VAT will be charged on the total value.
The destination country or territory considers the following items document shipments. If criteria are listed, the shipment must meet the criteria to be considered a document shipment.
Event tickets coming from a printing company and sent to the organizer of the event or ticket sales offices can not be sent as documents.
If over 3kgs, must be sent as a non-document shipment. The invoice must show the manufacturing costs of the ticket.
Non documents for weight above 5kg, proforma invoice required
In addition to the prohibited commodities listed here, it is prohibited to ship the following commodities to Croatia.
Food means any substance, whether processed, semi-processed or raw, which is intended for human consumption, but does not include cosmetics or substances used only as pharmaceuticals.
Non-Food (not intended for human consumption) includes animal by-products, animal feed, samples for testing or research purposes (food-grade or non-food grade), and in vitro diagnostics (IVD).
Animal products and animal by-products are often subject to a veterinary inspection. These products can only be accepted under a special contract for International Special Commodities (ISC). In addition those products must undergo veterinary checks at an approved Veterinary Border Inspection Post (BIP) when entering the EU & EFTA countries or territories (EU regulations are aligned for EU countries or territories and NO; IS; CH; LI).
For UPS shipments arriving in the EU by air, Cologne is the first point of arrival /BIP. Inspections will be processed at Cologne but final customs clearance process will be issued in the destination country or territory.
Additional charges for Vet-inspection will be applicable see Brokerage Services and Charges.
Import requirements:
Generally, each type of Product of Animal Origin has specific import requirements that must be met. Food which is subject to veterinary inspections must:
Come from an EU listed Third Country or Territory (no safeguard measures in place)
Come from an EU approved establishment . Registered producers are listed under the following link: http://ec.europa.eu/food/international/trade/third_en.htm
Be accompanied by appropriate Health Certificate(s), signed by a veterinarian of the competent authority of country or territory of export. Photocopies of the Health Certificate will not be accepted.
Be appropriately packaged and labelled, indicating the nature, ingredients, quantity/ weight, the country or territory of origin and manufacturer.
Any foodstuff coming from non-approved establishments, sent as samples for testing purposes, can only be imported with a permit/license from a respective national veterinary authority. The permit/license must be send to the border inspection point responsible for the veterinary inspection. Delays may occur as the license needs to be provided already at the time of inspection.
Any non-compliant shipment must be returned at shippers expense immediately. The following exemptions apply to non-commercial shipments / gift shipments or purchased by private individuals for private consumption):
Meat, meat products, animal fat - max. 10 kg from Faroe Island and Greenland.
Fish and fish products (with intestines and organs removed) - max. 20 kg from all third countries or territories; no limitation from Faroe Islands.
Other animal products (for example, honey, egg, frog, live mussels - max. 10 kg from Faroe Islands and Greenland, and max. 2 kg from all other third countries or territories).
All import, export, re-export and introduction from the sea of species covered by the Convention has to be authorized through a licensing system.
Shipper needs to provide the following documentation:
Invoice with the scientific name and CITES certificate.
Additional charges will be applicable. Products of animals or plants subject to CITES can only be accepted under a special contract for International Special Commodities (ISC).
An Import License from the Ministry of Health may be required.
Saturday Delivery Available: No
Always check Calculate Time and Cost for details of service availability and guarantee information within a country or territory. All Service Levels may not be available to or from every address within a country or territory.
The European Union implemented a directive restricting the use of certain hazardous substances in all Electronic & Electrical Equipment effective July 1, 2006. This directive is called the RoHS Directive (2005/618/EC), which stands for the Restriction of the use of certain Hazardous Substances in Electrical and Electronic Equipment.
The RoHS directive is closely linked with the Waste Electrical and Electronic Equipment Directive (WEEE) 2002/96/EC which sets collection, recycling and recovery targets for electrical goods.
These directives will ban the placing on the EU market of new electrical and electronic equipment containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) (PBB and PBDE are flame retardants used in some plastics).
Manufacturers (and distributors and individual sellers) will need to understand the requirements of the RoHS/WEEE Directives to ensure that their products, and their components, comply. Goods falling under these categories do not require any accompanying documentation for importation.
For more information on the EU directives, please check the following European Union web link or contact your local chamber of commerce: http://ec.europa.eu/environment/waste/pdf/faq_weee.pdf
Convert metric quantity for weight, length, and area.
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