GOODS regulations brief by exporTTLtd

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Market Survey of the French Caribbean Regulation & Standards

GUADELOUPE 127, rue Nobel Carré Nobel – ZI Jarry 97122 Baie-Mahault

MARTINIQUE 41, Bd Sainte Catherine 97200 Fort-de-France

Tel / Fax: 0590 24 56 82

Tel / Fax: 0596 54 22 10

Project Manager: Caroline Ventura, cventura@cayribe.com, +596 696 31 39 50

Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

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Versioning Date 04/27/2015 06/10/2015

Référence A B

Objet de la modification Document creation Completion : § 3.2.4. Custom duties (calculation method)

Approval Société

Nom

Fonction

Date

CAYRIBE

Caroline Ventura

Directrice Martinique

06/10/2015

Signature

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Table of Contents 1.

GENERAL REQUIREMENTS: THE IMPORT PROCEDURES TO RESPECT

1.1. Registering as an economic operator 1.1.1. Entry Summary Declaration (ENS) 1.1.2. Customs approved treatments

4 4 4

1.2. Documents for customs clearance 1.2.1. Commercial invoice 1.2.2. Customs value declaration 1.2.3. Single Administrative Document (SAD) 1.2.4. Freight documents 1.2.5. Freight insurance 1.2.6. Packing list 1.2.7. Certificate of origin

5 5 5 6 7 8 9 9

SPECIFIC REQUIREMENTS BY PRODUCT

2.1. Generality 2.2. Food and beverage 2.2.1. Food safety 2.2.2. Specific requirements 2.2.3. Labelling for foodstuffs 2.2.4. Food contact materials

11 11 11 13 19 24

2.3. Chemicals & Non-Metallic Minerals 2.3.1. Specific requirements

25 25

2.4. Paper, Printing, Packaging and Publishing 2.4.1. Specific requirements for plastic bottles 2.4.2. Specific requirements for article of paper pulp

43 43 47

2.5. Articles of Base Metal 2.5.1. Specific requirements for Iron, Steel, Aluminum and articles thereof

50 50

2.6. Wood and Wood Related Products 2.6.1. Specific requirements

53 53

TAXES AND IMPORT TARIFFS

3.1. Taxes and duties 3.1.1. The “Octroi de mer” 3.1.2. The Value Added Tax (VAT)

56 56 58

3.2. Import tariffs 3.2.1. Import Licensing 3.2.2. Foreign Exchange Controls 3.2.3. Trade barriers 3.2.4. Custom duties

59 59 59 59 59

ANNEXES

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1. General requirements: the import procedures to respect The principle of free movement of goods, allowing goods to be transported and sold anywhere in the EU, is a cornerstone of the EU market. To a certain extent, complex and varied national laws have been replaced by a single set of European rules, cutting down on costs and inconvenience for businesses wanting to trade with other EU countries. The EU market for goods is already highly integrated and harmonised throughout the 28 countries. However, to make the EU market work efficiently, businesses have to comply with a number of rules and compete fairly. To understand how the EU trade system is organised, the procedures to follow and the documents to fill in, are presented in the following section: documents for customs clearance1.

1.1.

Registering as an economic operator

The Economic Operator Registration and Identification (EORI) number is a unique identifier, assigned by a customs authority in an EU country to all economic operators (both companies and individuals) engaged in activities covered by EU customs legislation. Importers established outside the EU will be assigned an EORI the first time they lodge:  a customs declaration  an entry summary declaration (ENS)  an exit summary declaration (EXS) Operators use this number in all communications with any EU customs authorities where an EU-based identifier is required, for example in customs declarations.

1.1.1.

Entry Summary Declaration (ENS)

The entry summary declaration contains advance cargo information about consignments entering the EU. It must be lodged at the first customs office of entry to the EU by the carrier of the goods (in some cases it can be done by the importer-consignee, or a representative of the carrier or importer) - even if the goods are not going to be imported to the EU. The deadline for lodging the ENS depends on the mode of transport carrying the goods:  Container maritime cargo: at least 24 hours before loading commences in the foreign port  Bulk maritime cargo: at least 4 hours before arrival  Short sea shipping: at least 2 hours before arrival  Short haul flights (less than 4 hours): at least by the actual time of takeoff of the aircraft  Long haul flights (4 hours or more): at least 4 hours before arrival at the first airport in the customs territory of the EU  Road traffic: at least 1 hour before arrival. Note: The ENS requires information contained in documents originating with the exporter (bill of lading, commercial invoices, etc). Ensure that these documents reach the party responsible for lodging the declaration in time.

1.1.2.

Customs approved treatments

When goods arrive at the customs office of entry in the EU, they are placed into temporary storage under customs supervision (no longer than 45 days in the case of goods carried by sea, or 20 days in other cases) until they are assigned one of the following customs approved treatments or uses: 1. Release for free circulation 1 Template and specimen are available in annex form some documents

Des entrepreneurs au service des entrepreneurs Goods are released for consumption once all the import requirements have been met:  all applicable tariff duties, VAT and excise duties have been paid  all applicable authorisations and certificates (e.g. for quotas, health requirements, etc.) have been presented. 2. Transit procedure When goods are moved between customs offices in different EU countries, customs clearance formalities can be transferred to the customs office of destination. 3. Customs warehousing Imported goods can be stored in specially designated facilities, and duties, taxes and formalities suspended until the goods are assigned another customs approved treatment. 4. Inward processing Goods can be imported into the EU, without being subject to duties, taxes and formalities, to be processed under customs control and then re-exported out of the EU. If the finished products are not finally exported, they become subject to the applicable duties and formalities. 5. Temporary importation Goods can enter the EU without payment of import duties, provided they are intended for re-export without undergoing any change. The maximum period for temporary import is 2 years. 6. Entry into a free zone or warehouse Free zones are special areas within the EU customs territory where goods can enter without payment of customs duties, VAT and excise duties, and without other import formalities until they are either assigned another approved customs treatment or reexported. Under this procedure, goods may also undergo simple operations such as processing and re-packing.

1.2. 1.2.1.

Documents for customs clearance Commercial invoice

The commercial invoice is a record or evidence of the transaction between the exporter and the importer. Once the goods are available, the exporter issues a commercial invoice to the importer in order to charge him for the goods.The commercial invoice and is always required for customs clearance. The minimum data generally included are the following:            

Information on the exporter and the importer (name and address) Date of issue Invoice number Description of the goods (name, quality, etc.) Unit of measure Quantity of goods Unit value Total item value Total invoice value and currency of payment. The equivalent amount must be indicated in a currency freely convertible to Euro or other legal tender in the importing EU country The terms of payment (method and date of payment, discounts, etc.) The terms of delivery according to the appropriate Incoterm Means of transport

No specific form is required. The commercial invoice is to be prepared by the exporter according to standard business practice and it must be submitted in the original along with at least one copy. In practice, both the original and the copy of the commercial invoice are often signed. The commercial invoice may be prepared in any language.

1.2.2.

Customs value declaration

A Customs Value Declaration must be presented to the customs authorities where the value of the imported goods exceeds €10 000. The Customs Value Declaration must be drawn up conforming to form DV 1. Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs This form must be presented with the Single Administrative Document (SAD). The main purpose of this requirement is to assess the value of the transaction in order to fix the customs value (taxable value) to apply the tariff duties. The customs value corresponds to the value of the goods including all the costs incurred (e.g.: commercial price, transport, insurance) until the first point of entry in the European Union. The usual method to establish the Customs value is using the transaction value (the price paid or payable for the imported goods). In certain cases the transaction value of the imported goods may be subject to an adjustment, which involves additions or deductions. For instance:  commissions or royalties may need to be added to the price;  the internal transport (from the entry point to the final destination in the Community Customs Territory) must be deducted. The customs authorities must waive the requirement of all or part of the customs value declaration where:  the customs value of the imported goods in a consignment does not exceed €10 000, provided that they do not constitute split or multiple consignments from the same consignor to the same consignee, or  the importations involved are of a non-commercial nature; or  the submission of the particulars in question is not necessary for the application of the Customs Tariff of the European Community or where the customs duties provided for in the Tariff are not chargeable pursuant to specific customs provisions. Legislation: EU Regulation 2913/92 establishing the Community Customs Code EU Regulation 2454/93 on the implementation of the Community Customs Code

1.2.3.

Single Administrative Document (SAD)

The SAD is the common import declaration form for all EU countries to declare goods to the customs authorities. It may be presented either by:  Using an approved computerized system linked to Customs authorities ; or  Lodging it in the designated Customs Office premises. The main information that shall be declared is:  Identifying data of the parties involved in the operation (importer, exporter, representative, etc.)  Customs approved treatment (release for free circulation, release for consumption, temporary importation, transit, etc.)  Identifying data of the goods (Taric code, weight, units), location and packaging  Information referring to the means of transport  Data about country of origin, country of export and destination  Commercial and financial information (Incoterms, invoice value, invoice currency, exchange rate, insurance etc.)  List of documents associated with the SAD (Import licenses, inspection certificates, document of origin, transport document, commercial invoice, etc.)  Declaration and method of payment of import taxes (tariff duties, VAT, Excises, etc) The SAD set consists of eight copies, the operator completes all or part of the sheets depending on the type of operation. To export to the EU, generally three copies shall be used: one is to be retained by the authorities of the EU country in which arrival formalities are completed, the other is used for statistical purposes by the country of destination and the last one is returned to the consignee after being stamped by the customs authority. Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

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Documents associated with the SAD According to the operation and the nature of the imported goods, additional documents must be declared with the SAD and presented together with it. The most important documents are:  documentary proof of origin, normally used to apply a tariff preferential treatment  certificate confirming the special nature of the product  transport document  commercial Invoice  customs value declaration  inspections certificates (health, veterinary, plant health certificates)  import licenses  Community surveillance document  CITES certificate  documents to support a claim for a tariff quota  documents required for Excise purposes  evidence to support a claim for VAT relief

1.2.4.

Freight documents

Depending on the means of transport used, these documents are to be filled in and presented to the customs authorities of the importing EU country upon importation in order for the goods to be cleared.

1.2.4.1.

Bill of Lading (B/L)

Issued by the shipping company to the operating shipper, confirming that the goods have been received on board. In this way the Bill of Lading serves asproof of receipt of the goods by the carrier obliging him to deliver the goods to the consignee. It contains the details of the goods, the vessel and the port of destination. It evidences the contract of carriage and conveys title to the goods, meaning that the bearer of the Bill of Lading is the owner of the goods. The Bill of Lading may be a negotiable document. A number of different types of bills of lading can be used. "Clean Bills of Lading" state that the goods have been received in an apparent good order and condition. "Unclean or Dirty Bills of Lading" indicate that the goods are damaged or in bad order, in this case, the financing bank may refuse to accept the consignor's documents.

1.2.4.2.

FIATA Bill of Lading

A document designed to be used as a multimodal or combined transport document with negotiable status. Developed by the International Federation of Freight Forwarders Associations (FIATA).

1.2.4.3.

Air Waybill (AWB)

A document which serves as a proof of the transport contract between the consignor and the carrier's company. It is issued by the carrier's agent and falls under the provisions of the Warsaw Convention (Convention for the Unification of Certain Rules relating to International Carriage by Air, 12 October 1929). A single air waybill may be used for multiple shipments of goods; it consists of three originals and several extra copies. One original is kept by each of the parties involved in the transport (the consignor, the consignee and the carrier). The copies may be required at the airport of departure/destination, for the delivery and in some cases, for further freight carriers. The air waybill is a freight bill, which evidences a contract of carriage and proves receipt of goods. A specific type of Air Waybill is the one used by all carriers belonging to the International Air Transport Association (IATA); a bill called the IATA Standard Air Waybill. It embodies standard conditions associated with those set out in the Warsaw Convention.

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1.2.4.4.

ATA Carnet

Admission Temporaire/Temporary Admission carnets are international customs documents issued by the chambers of commerce in the majority of the industrialized world to allow the temporary importation of goods, free of customs duties and taxes. ATA carnets can be issued for the following categories of goods: commercial samples, professional equipment and goods for presentation or use at trade fairs, shows, exhibitions and the like.

1.2.4.5.

TIR Carnet

Customs transit documents used for the international transport of goods, a part of which has to be made by road. They allow the transport of goods under a procedure called the TIR procedure (1975 TIR Convention, signed under the auspices of the United Nations Economic Commission for Europe (UNECE). The TIR system requires the goods to travel in secure vehicles or containers, all duties and taxes at risk throughout the journey to be covered by an internationally valid guarantee, the goods to be accompanied by a TIR carnet, and customs control measures in the country of departure to be accepted by the countries of transit and destination.

1.2.5.

Freight insurance

Insurance covers common risks during handling, storing, loading or transporting cargo, but also rare risks, such as riots, strikes or terrorism. There is a difference between the goods transport insurance and the carrier's responsibility insurance. The covered risks, fixed compensation and indemnity of the contract of transport insurance are left to the holder's choice. Nevertheless, the hauler's responsibility insurance is determined by different regulations. Depending on the means of transport, indemnity is limited by the weight and value of the goods and is only given in cases where the transporter cannot be held responsible. The insurance invoice is required for customs clearance only when the relevant data do not appear in the commercial invoice indicating the premium paid to insure the merchandise. The standard extent of the transporter's responsibility is laid down in the following international conventions:

1.2.5.1.

Road freight

International transport of goods by road is governed by the Convention for the Contract of the International Carriage of Goods by Road (CMR Convention) signed in Geneva in 1956. Under this Convention, the road hauler is not responsible for losses of or damages to the goods if he proves that they arise from:  the merchandise's own defect(s);  force majeure;  a fault by the loader or consignee. There is no EU regulation regarding indemnifications for road freight.

1.2.5.2.

The shipping compagny

The 1968 International Convention on Bills of Lading, also known as "The Hague Rules" or the "Brussels Convention" dictates the marine carrier's responsibilities when transporting international goods. The shipping company is not responsible for losses of, or damage to, the goods if it proves that they arise from:  the merchandise's own defects and loss in weight during transport  a nautical mistake by the crew  a fire  the ship being unseaworthy  force majeure  strikes or a lock-out  a mistake by the loader  hidden defects on board ship, which went unnoticed during rigorous inspection Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

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an attempt to save lives or goods at sea.

There is no harmonisation at EU level regarding compensation. It is normally limited to a certain sum per kilo of lost or damaged goods. This system causes the same problems as with rail accidents, namely that the exporter is likely to lose much of the value of the goods.

1.2.5.3.

The air carrier

The 1929 Warsaw Convention as well as the Montreal draft Treaty of 1975 state that the air carrier is not responsible for damages or loss of goods if it can be proven that:  the carrier and associates took all the measures necessary to avoid the damage or that it was impossible for them to be taken (force majeure);  the losses arise from a pilotage or navigation mistake;  the injured party was the cause of the damage or contributed to it. There is no EU standard concerning the injured party's indemnification. Compensation is normally limited to a set amount per gross kilo of damaged or lost goods. The air carrier can state specific reservations at the time of receiving the cargo. These reservations will be written on the air consignment note (ACN) (air transport contract) and will be used as evidence. However, airlines will normally refuse dubious packages or those not corresponding to the ACN.

1.2.6.

Packing list

The packing list (P/L) is an inventory of the incoming cargo required for customs clearance and accompanying the commercial invoice and the transport documents. It generally includes the following:  the exporter, the importer and the transport company  date of issue  number of the freight invoice  type of packaging (drum, crate, carton, box, barrel, bag, etc.)  number of packages  content of each package (description of the goods and number of items per package)  marks and numbers  net weight, gross weight and measurement of the packages No specific form is required. The packing list is to be prepared by the exporter according to standard business practice and the original along with at least one copy must be submitted. Generally there is no need for it to be signed. However, both the original and the copy of the packing list are often signed. The packing list may be prepared in any language, although a translation into English is recommended.

1.2.7.

Certificate of origin

The certificate of origin is a “CERFA form” certifying the origin of the goods placed on the international market. The certification of the origin of goods is requested by many countries. The reasons are varied:  determination of tariffs,  implementation of specific regulations,  implementation of specific trade policies,  counter deflection of trade,... The Certificate of Origin is issued in France by the Chambers of Commerce and Industry authorized by the Ministry of Justice to legalize commercial documents drawn up under private signature and to be presented abroad. It consists of several layers: the original (only one copy) in sepia, yellow copies of a copy kept by the ICC and the pink color request for the ICC.

Des entrepreneurs au service des entrepreneurs The certificate of origin must be completed (typewritten, some countries refusing manuscripts CO) by the exporter who introduced him to the ICC of nationality for visa on the basis of the request for issuance. The leaflets are available through the Chambers of Commerce and Industry. The issuance of this publication, used by all member countries of the European Union, follows rules defined by all of these countries. Each frame corresponds to accurate information should be carefully.

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2. Specific requirements by product The following section will present the specific requirements on the product, its labelling and packaging requirements for EU market access:  health and safety,  technical standards,  labelling & packaging,  food safety,  product-specific marketing standards, etc) Specific requirements depend on the product Health and consumer protection, marketing standards, technical standards, ecodesign, food from organic production, chemicals.

2.1.

Generality

Goods imported into the EU must meet the EU sanitary and phytosanitary requirements to protect human health. The EU rules on official controls are divided in two Regulations intended to be implemented by competent authorities. One sets out the official control principles and obligations and the other how official controls are to be organised by the competent authorities, as follows: 



Official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Regulation (EC) n°882/2004 of the European Parliament and of the Council of April 29, 2004 Trade Events & Fairs calendar Import requirements and the new rules on food hygiene and official food controls

EU rules on food safety are designed to protect human life and health while the rules on animal feed aim at protecting human and animal life and health. Imports of foodstuffs must comply with general conditions, which include:       

general principles and requirements of food law - all stages of food/feed production and distribution (Regulation (EC) N°178/2002 – Section 4) traceability - importers of food and feed products must identify and register the supplier in the country of origin (Regulation (EC) N°178/2002 – Article 18) rules on microbiological criteria for foodstuffs rules on residues, pesticides, veterinary medicines and contaminants in and on food special rules on certain groups of food products (e.g. mineral waters, cocoa, quick-frozen food) and foodstuffs aimed at specific populations (e.g. foods for infants and young children) specific marketing and labelling requirements for feed materials general rules on materials intended to come into contact with foodstuffs

If a problem likely to pose a serious risk to human or animal health or to the environment arises in a non-EU country, the EU may adopt protective measures, either imposing special conditions or suspending imports of products from all or part of the country concerned.

2.2. 2.2.1.

Food and beverage Food safety

The objective of the European Union's food safety policy is to protect consumer health and interests while guaranteeing the smooth operation of the single market. In order to achieve this objective, the EU ensures that control standards are established and adhered to as regards food and food product hygiene, animal health and welfare, plant health Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs and preventing the risk of contamination from external substances. It also lays down rules on appropriate labelling for these foodstuffs and food products. This policy underwent reform in the early 2000s, in line with the approach 'From the Farm to the Fork', thereby guaranteeing a high level of safety for foodstuffs and food products marketed within the EU, at all stages of the production and distribution chains. This approach involves both food products produced within the European Union and those imported from third countries. Contamination and environmental factors The European Union takes care to prevent and limit any contamination of foodstuffs by certain undesirable substances or as a result of human activities. The EU thus regulates the use of certain specific chemical substances, such as those used in farming or in certain production or food processing techniques. Measures are also taken to limit contamination from the pollution of water or air, or from exposure to radioactivity. The risks of contamination by genetically modified organisms and by food packaging are also monitored. Contaminants are substances not intentionally added to food. These substances may be present in food as a result of production, packing, transport or storage, or as a result of environmental contamination. In order to limit the negative impact of contaminants in food and to prevent the risks to human health, the European Union (EU) is taking measures to reduce the level of contaminants in food. Council Regulation (EEC) N°315/93 of 8 February 1993 laying down Community procedures for contaminants in food

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2.2.2.

Specific requirements

Product Description Curry Chocolate confectionery Other, spaghetti, macaroni, noodles, shells Other [Prepared corn products incl cereals] Sweet biscuits Wafers & waffles Other [Roti skins] Prepared corn products Prepared potato & multigrain products Other [Fried & Pepper - Chick Peas or Split Peas] Other orange juices Other mixtures, fruit juices Tomato ketchup Other tomato sauces [BBQ Sauce] Pepper sauce Mayonnaise Amchar, kuchela and similar preparations Other sauces and preparations [incl Green liquid seasoning; powdered seasoning] Aerated waters & beverage, Other drinks

Control of contaminants in foodstuffs

Control of residues of veterinary medicines

Control of pesticide residues

Health control of foodstuffs of nonanimal origin

Traceability, compliance and responsibility in food and feed

Labelling for foodstuffs

Voluntary - Products from organic production

X X

X X X

X X X X X X

Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B

CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

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2.2.2.1.

Control of contaminants in foodstuffs

In order to ensure a high level of consumer protection, imports into the European Union (EU) of foodstuffs must comply with EU legislation designed to ensure that food placed on the market is safe to eat and does not contain contaminants at levels which could threaten human health. Contaminants may be present in food (including fruits and vegetables, meat, fish, cereals, spices, dairy products, etc.) as a result of the various stages of its production, packaging, transport or holding, or also might result from environmental contamination. Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food, regulates the presence of such contaminants in foodstuffs in the EU:  food containing a contaminant to an amount unacceptable from the public health viewpoint and in particular at a toxicological level, shall not be placed on the EU market and will be rejected  contaminant levels shall be kept as low as can reasonably be achieved following recommended good working practices  maximum levels may be set for certain contaminants in order to protect public health Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs sets maximum levels for certain contaminants in food to be placed on the EU market. The foodstuffs indicated in the various sections of the Annex2 must not, when placed on the market, contain higher contaminant levels than those specified in such sections:  Section 1 – sets limits for nitrate in lettuce, spinach and baby foods.  Section 2 – sets limits for various mycotoxins in, for example, groundnuts, nuts, dried fruit (including dried vine fruit) and products thereof, cereals and cereal products, milk, infant formulae, dietary foods intended for infants, spices, fruit juices, coffee products, wine, spirit drinks, cider, apple products, processed cereal based foods for infants and young children and baby foods.  Section 3 – sets limits for various heavy metals in, for example, milk, meat, fish, cereals, vegetables, fruit and wines.  Section 4 – sets limits for 3-MCPD in Hydrolysed vegetable protein and soy sauce.  Section 5 – sets limits for dioxins and dioxin-like PCBs in meat, fish, milk, eggs, oils and fats.  Section 6 – sets limits for PAHs in oils and fats, smoked meats, smoked fish, fish, crustaceans and bivalve molluscs, infant foods. Legislation  Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food  Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs

2 http://exporthelp.europa.eu/update/requirements/ehir_eu15_02v001/eu/auxi/eu_heafocon_annex_r1881_2006.pdf

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2.2.2.2. Control of residues of veterinary medicines in animals and animal products for human consumption (Only required for vegetable preparations containing products of animal origin for human consumption)

In order to ensure a high level of consumer protection, imports into the European Union (EU) of animal products intended for human consumption are only permitted when they comply with guarantees laid down in EU legislation designed to control the presence of chemical substances and residues thereof in live animals and animal products. The products concerned by this requirement are: bovine, ovine, caprine, porcine and equine animals, poultry, aquaculture, milk, eggs, rabbit meat, wild and farmed game meat and honey. Legislation  Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L-125 23/05/1996)  Commission Decision 2011/163/EU of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC (OJ L-70 17/03/2011)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L-152 16/06/2009)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L-15 20/01/2010)  Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L-15 20/01/2010)  Commission Decision 98/536/EC of 3 September 1998 establishing the list of national reference laboratories for the detection of residues (OJ L-251 11/09/1998)  Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries (OJ L-21 28/01/2004)

2.2.2.3. Control of pesticide residues in plant and animal products intended for human consumption In order to ensure a high level of consumer protection, imports of plant and animal products or parts thereof intended for human consumption in or on which residues of pesticides may be present, are only permitted when complying with guarantees laid down by EU legislation designed to control the presence of chemical substances and residues thereof in live animals, animal products and products of plant origin. The placing on the market of these products is covered by two main Directives: Animals and animal products Council Directive 96/23/EC (OJ L-125 23/05/1996) outlines the procedure to evaluate whether when importing animals and animal products, the guarantees on residues of chemical substances presented by a third country can be deemed equivalent to those requested to the products produced under EU rules. Such products shall only be imported from authorised countries included in the list published in Commission Decision 2011/163/EU (OJ L-70 17/03/2011). Inclusion and retention on this list shall be subject to submission by the third country concerned of a

Des entrepreneurs au service des entrepreneurs plan setting out the guarantees which it offers as regards the monitoring of the groups of residues and substances referred to in Annex I to the Directive. Plants, plant products and their protection Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ L-309 24/11/2009) lays down rules and procedures for active substances to be marketed in the EU and for the authorization by Member States of plant protection products containing them. Active substances cannot be used in plant protection products unless they are included in a positive EU list. Such substances are included in the EU Pesticide Database. Once a substance is included in the list, Member States may authorize the use of products which contain it. Control of pesticide residues in the EU: the maximum residue levels (MRLs) As from 1 September 2008, Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L-70 16/03/2005) defines a fully harmonized set of rules for pesticide residues. This Regulation lays down provisions for the setting of EU pesticide maximum residue levels (MRLs) in food and feed. Legislation  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L-309 24/11/2009)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L-153 11/0/2011)  Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L-125 23/05/1996)  Commission Decision 2011/163/EU of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC (OJ L-70 17/03/2011)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels (MRLs) of pesticides in products of plant and animal origin (OJ L-70 16/03/2005)  Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of nonanimal origin and amending Decision 2006/504/EC (OJ L-194 25/07/2009)  Commission Decision 98/536/EC of 3 September 1998 establishing the list of national reference laboratories for the detection of residues (OJ L-251 11/09/1998)  Commission Implementing Regulation (EU) No 788/2012 of 31 August 2012 concerning a coordinated multiannual control program of the Union for 2013, 2014 and 2015 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L-235 01/09/2012)

2.2.2.4.

Health control of foodstuffs of non-animal origin

Imports of foodstuffs of non-animal origin into the European Union (EU) must comply with general conditions and specific provisions designed to prevent risk to public health and protect consumers' interests. Hence, the general rules applicable to these products are as follows: 1. General foodstuffs hygiene rules according to Regulation (EC) No 852/2004 of the European Parliament and of the Council (OJ L-139 30/04/2004) ; 2. General conditions concerning contaminants in food; a) Maximum levels of certain contaminants in foodstuffs Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs b) Maximum levels of pesticide residues in and on food c) Maximum levels of radioactive contamination of foodstuffs d) Materials intended to come into contact with foodstuffs 3. Special provisions on Genetically Modified (GM) food and novel food of Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L-268 18/10/2003) and Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L-43 14/02/1997) ; 4. General conditions of preparation of foodstuffs; a) Authorized food additives and flavorings b) Preparation and treatments of certain foodstuffs c) Specific provisions for certain groups of products and for foodstuffs for particular nutritional purposes 5. Official control of foodstuffs Regulation (EC) No 882/2004 of the European Parliament and of the Council (OJ L-165 30/04/2004) establishes the EU framework of general rules for the organization of official controls on foodstuffs. When a hygiene problem likely to pose a serious risk to human health arises or spreads in the territory of a third country, the European authorities may suspend imports from all or part of the third country concerned or take interim protective measures regarding the foodstuffs concerned, depending on the seriousness of the situation.

2.2.2.5.

Traceability, compliance and responsibility in food and feed

According to EU food safety legislation, food and feed cannot be placed on the market in the European Union (EU) if they are unsafe. EU Food Law pursues not only a high level of protection of human life and health and consumers’ interests but also the protection of animal health and welfare, plant health and the environment. Food and feed business operators shall comply with the specific obligations laid down by Regulation (EC) No 178/2002 of the European Parliament and of the Council (OJ L-31 01/02/2002), covering all stages of food/feed production and distribution: 1. Compliance with Food Law Imported food and feed must comply with the relevant requirements of food law or conditions recognized by the EU to be at least equivalent thereto. The competent authority of the exporting country must offer guarantees as to the compliance or equivalence with the EU requirements. 2. Traceability The EU Law defines traceability as the ability to trace and follow any food, feed, foodproducing animal or substance that will be used for consumption, through all stages of production, processing and distribution. The scope of the traceability requirement is limited to the following products and operators: Products: Traceability is always required for any substance intended to be, or expected to be, incorporated into food or feed. Operators: This provision aims at ensuring that food business operators are able to identify the immediate supplier of a product and the immediate subsequent consignee (“one step back-one step forward” principle), from the EU importer up to retail level, excluding supply to the final consumer.

Des entrepreneurs au service des entrepreneurs Food or feed, which is placed or is likely to be placed on the market in the EU, shall also be adequately labelled or identified to facilitate its traceability, through relevant documentation or information on the product particulars. Therefore, traceability allows:  Responding to potential risks that may arise in food and feed,  Targeted withdrawals of unsafe food from the market  The provision of accurate information to the public, thereby minimising disruption to trade 3. Responsibilities of food and feed importers Food business operators at all stages of production, processing and distribution within the businesses under their control, shall ensure that foods satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met. If a food business operator has reason to believe that imported food or feed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question and inform the competent authorities thereof. Legislation Regulation (EC) No 178/2002 of the European Parliament and of the Council (OJ L-31 01/02/2002)

2.2.2.6.

Voluntary - Products from organic production

The placing on the European Union (EU) market of live or unprocessed agricultural products, processed agricultural products for use as food, animal feed, seeds and vegetative propagating material, bearing a reference to organic production methods, must comply with the rules laid down by Council Regulation (EC) No 834/2007 (OJ L-189 20/07/2007). These rules, established by Council Regulation (EC) No 834/2007 and Commission Regulation (EC) No 889/2008 (OJ L-250 18/09/2008) cover mainly the following aspects:  Production, processing, packaging, transport and storage of products  Use of certain products and substances in processing of food  A list of ingredient authorizations is available in the Data base of the Organic Farming Information System (OFIS)  Prohibition of use of genetically modified organisms (GMO) and of products manufactured from GMO in organic production  European Union organic production logo. The logo and indications referring to organic production methods may be used only for certain products which meet all the conditions laid down by Regulation.  Inspection measures and specific control scheme to be applied for this type of products by the appointed authorities in the Member States. Legislation  Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L-189 20/07/2007)  Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (OJ L-250 18/09/2008)  Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (OJ L-334 12/12/2008) Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs 

List of bodies or public authorities in charge of inspection provided for in article 15 of Regulation (EEC) No 2092/91 (OJ C-72 26/03/2009)

2.2.3.

Labelling for foodstuffs

All foodstuffs marketed in the European Union (EU) must comply with EU labelling rules, which aim at ensuring that consumers get all the essential information to make an informed choice while purchasing their foodstuffs. There are two types of labelling provisions which are applicable to foodstuffs: 1. General rules on food labelling 2. Specific provisions for certain groups of products:

The new Regulation (EU) N°1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (OJ L-304 22/11/2011) (CELEX 32011R1169) changes existing legislation on food labelling. According to Regulation (EU) No 1169/2011, a nutrition declaration will be mandatory from 13th December 2016. On the other hand, Council Regulation (EC) No 834/2007 (OJ L-189 20/07/2007 and Commission Regulation (EC) No 889/2008 (OJ L-250 18/09/2008) set out rules governing the use of the organic label.

2.2.3.1.

General rules on food labelling

The following table shows the former and the new legislation on the mandatory food information which must accompany any food intended for supply to the final consumer: Issue Name of the food

List of ingredients

Net Quantity

Legislation from 13/12/2004 The name of the foodstuff shall be its legal name. It shall not be replaced with a name protected as intellectual property, brand name or fancy name. Specific provisions on the name of the food and particulars that shall accompany it are laid down in Annex VI to the Regulation Preceded by the word "Ingredients", the list shall include all ingredients (including additives or enzymes) in descending order of weight as recorded at the time of their use in the manufacture and designated by their specific name. Names of ingredients present in the form of engineered nanomaterials shall be included and followed by the word "nano" in brackets. Any ingredient or processing aid listed or derived from a substance or product listed in Annex II to the Regulation causing allergies or intolerances, even if it is included in the final product in an altered form, shall be indicated in the list of ingredients and emphasised through a typeset in order to clearly distinguish it from other ingredientes (i.e. font, style or background colour) The indication of the quantity of an ingredient or category of ingredients used in the manufacture or preparation of a food shall be required where such an ingredient/category of ingredients: •appears in the name of the food or is usually associated with it by the consumer; •is emphasised on the labelling in words, pictures or graphics; or • is essential to identify a food and to distinguish it from other similar products. It shall be expresed in units of volume in the case of liquid products (litre, centilitre, millilitre) and units of mass in the case of other products (kilogram, gram) Foods which are sold in a liquid medium must also label the

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Minimum durability date

Storage conditions conditions of use

Country of origin or place of provenance

Instructions of use Alcoholic strength

Lot marking Nutrition declaration

Additional information for France

drained net weight of the food For glazed frozen foods the net weight should be exclusive of the ice glaze It shall be the date until which the foodstuff retains its specific properties when properly stored. The date shall consist of day, month and year in that order and preceded by the words "best before" or "best before end". When foods are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health, the date of minimum durability shall be replaced by the "use by" date. Where foods require special storage conditions and/or conditions of use, they shall be indicated. Once the package is opened, in order to enable appropriate storage or use of the food, the storage conditions and/or time limit for consumption shall be indicated, when needed Indication of these issues shall be mandatory: • where failure to indicate this might mislead the consumer as to the true country of origin or place of provenance of the food •for meat falling within the Combined Nomenclature codes listed in Annex XI. Where the country of origin or the place of provenance of a food is different than of its primary ingredient, the latter shall also be given or indicated as being different to that of the food Instructions for use of a food shall be indicated to enable appropriate use. The rules concerning indication of the alcoholic strength by volume of products classified in CN code 2204, shall be laid down in specific Union provisions applicable to such products. The actual alcoholic strength of products containing more than 1,2% of alcohol different from those classified in CN code 2204, shall be indicated in accordance with Annex XII Indication which allows identification of the lot to which the foodstuff belongs shall be affixed on pre-packaged foodstuffs preceded by the letter "L" Note: It will not be compulsory until 13th December 2016 Mandatory content: •energy value •the amounts of fat, saturates, carbohydrate, sugars, protein and salt Non-mandatory content: •mono-unsaturates •polyunsaturates •polyols •starch •fibre •vitamins or minerals The contents of the label must be at least in French. The compliance with the labelling requirements and the accuracy of the information contained in the label can be checked at any stage of the distribution chain (e.g. customs clearance, distributors warehouses, wholesalers or retailers outlets …). Competent authority / competent bodies - Ministry of Economy, Industry and Digital Economy - Directorate General for Competition, Consumer Affairs and Anti-fraud - Service for Consumer Protection and Market Regulation - Sub-Division of Foodstuffs and Agricultural and Food Markets) - French Agency for Food, Environmental and Occupational Health and Safety) Legislation - Code of Consumer Protection (Regulatory Part - Council Decrees governmental issuers, Book I , Title I, Chapter II)

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These particulars must appear on the packaging or on a label attached to pre-packaged foodstuffs. In the case of pre-packaged foodstuffs intended for mass caterers (foodstuffs sold in bulk), the compulsory labelling particulars must appear on commercial documents while the name under which it is sold, the date of durability or use-by-date and the name of manufacturer must appear on the external packaging. The labelling must not mislead the purchaser as to the foodstuff’s characteristics or effects nor attribute the foodstuff special properties for the prevention, treatment or cure of a human disease. The information provided by labels must be easy to understand, easily visible, clearly legible and indelible and must appear in the official language(s) of the Member State where the product is marketed. However, the use of foreign terms or expressions easily understood by the purchaser may be allowed.

2.2.3.2.

Specific provisions for certain groups of products

Labelling of Genetically Modified (GM) food and novel food Products consisting of or containing Genetically Modified Organisms (GMOs) and food products obtained from GMOs which have been authorized for the placing on the EU market are subject to labelling requirements pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L-268 18/10/2003) (CELEX 32003R1829) and Regulation (EC) No 1830/2003 of the European Parliament and of the Council (OJ L268 18/10/2003) (CELEX 32003R1830). In the case of pre-packaged products, operators are required to state on a label that “This product contains genetically modified organisms”. This labelling obligation also applies to highly refined products (e.g. oil obtained from genetically modified maize) as well as GM additives and flavorings. Labelling of foodstuffs for particular nutritional purposes In addition to the rules applicable to foodstuffs in general, specific provisions (e.g. declaration of the energy value, carbohydrate, protein and fat content, etc.) for groups of foods for particular nutritional uses (baby foods, dietary foods for special medical purposes, foods for weight reduction, foods for sportspeople, etc.) are laid down in specific Directives These products must be suitable for their claimed nutritional purposes and marketed in such a way as to indicate their suitability. Labelling of food additives and flavourings Additives and flavorings must always be labelled on the packaging of food products by their category (anti-oxidant, preservative, color, etc.) with their name or E-number. Other provisions on labelling of additives sold as such to food producers and consumers are laid down in Regulation (EC) No 1333/2008 (OJ L-354 31/12/2008) and Regulation (EC) No 1334/2008 (OJ L-354 31/12/2008). Labelling of materials intended to come into contact with food According to Regulation (EC) No 1935/2004 of the European Parliament and of the Council (OJ L-338 13/11/2004), articles intended to come into contact with foodstuffs, including packaging materials and containers shall be labelled "for food contact" or shall bear the symbol with a glass and fork. Labelling of particular foodstuffs Provisions in relation with the labelling of certain products are established in specific EU legislation. According to this matter we can quote the following examples:

Des entrepreneurs au service des entrepreneurs  Fruit juices and certain similar products The composition of fruit juices, their reserved names, their manufacturing characteristics and their labelling are subject to specific rules. Council Directive 2001/112/EC of 20 September 2001 relating to fruit juices and certain similar products intended for human consumption. The products covered by this Directive are: o fruit juice, o concentrated fruit juice, o dehydrated fruit juice, and o fruit nectar. These products are defined on the basis of their composition and preparation processes so as to ensure that the terms are used correctly in trade, and not in a manner which may mislead. The Directive also defines particular designations used in certain countries and languages. Labelling Fruit juices are labelled in accordance with the general rules laid down in Directive 2000/13/EC relating to foodstuffs. However, specific provisions are adopted in this Directive in order to improve consumer information. These provisions require the addition of wording indicating: o if a product is a mixture of different fruits; o if a product has been sweetened; o if a product has been obtained entirely or partly from a concentrate In the case of concentrated fruit juice, if the product is not intended for delivery to the final consumer, the labelling must indicate any addition of sugars, lemon juice or acidifying agents. The Directive lists the raw materials which may be used to manufacture juice and nectar, and also the additives which may be authorized, subject to the Directive on nutrition labelling for foodstuffs. The minimum content of fruit juice and/or fruit purée in fruit nectar must conform to the levels indicated in the Directive and must be stated in the product labelling. Background This Directive forms part of the program to simplify certain vertical Directives relating to foodstuffs. It applies without prejudice to the general provisions relating to the labelling of foodstuffs.  Natural mineral waters The harmonization of the provisions concerning natural mineral waters improves their free movement in the internal market. This Directive also enhances consumer protection, and lays down the conditions for prevention and intervention in the event of threats to public health. Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (Recast) - Text with EEA relevance. The harmonization defined by this Directive promotes the marketing of natural mineral waters in the internal market. Natural mineral waters are characterized by their original purity, their specific nature (particularly a high mineral or trace element content) and in some cases by their effects. Their characteristics must be recognized by the competent national authorities, whether the water has been extracted from the ground of a Member State or has been imported into the Community. Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs Member States communicate the list of recognized mineral waters to the Commission. This list is published in the Official Journal of the European Union. This Directive does not apply to waters which are medicinal products within the meaning of Directive 2001/83/EC and to natural mineral waters which are used at source for curative purposes (in the case of thermal or hydro-mineral establishments). Treatment and potability of water Only three treatments are authorized, insofar as they do not alter the composition of the water as regards its essential constituents. These are: o the separation of unstable elements; o the separation of iron, manganese, sulphur and arsenic compounds by treatment with ozone and under the conditions laid down by the Commission following consultation of the European Food Safety Agency (EFSA); o the separation of other undesirable constituents in compliance with the conditions for use laid down by the Commission following consultation of the EFSA. The revivable total colony count and the number of parasites and pathogenic microorganisms is checked at source and when the water is bottled. When marketed, a higher bacterial count may only be due to a normal increase. Water must not have any defects from the point of view of touch, taste and smell. It must be packaged in a container which avoids the possibility of adulteration or contamination. Labelling The general rules for labelling, presentation and advertising are set out in Directive 2000/13/EC. The sales description of natural mineral water is strictly controlled according to its characteristics and any treatments. Labelling includes mandatory information: o the statement of analytical composition; o the name of the spring and the place of exploitation; o information on any treatments. Indications attributing properties relating to the prevention, treatment or cure of a human illness are prohibited. The properties of the water may be mentioned, in compliance with this Directive or according to the criteria established at national level by recognized scientific methods. Marketing A Member State may temporarily restrict or suspend trade in a product circulating freely within its territory. It must first inform the Commission and the other Member States, and justify its decision. Powers of the Commission The Commission is assisted by the Standing Committee on the Food Chain and Animal Health. It may take measures concerning: o limits for the concentrations of constituents of waters; o the indication on the labelling of high levels of certain constituents; o the use of ozone-enriched air; o information on treatments; o checks on microbiological characteristics. It takes all necessary decisions in the event of a threat to public health, following consultation of the EFSA. Context Directive 80/777/EEC is repealed so as to recast its successive amendments. Member States must however continue to transpose its amending directives, since these provisions are considered as amending Directive 2009/54/EC.

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2.2.4.

Food contact materials

Food contact materials are materials and articles intended to come into contact with foods such as:     

Packaging materials; Cutlery and dishes; Processing machines; Containers; Materials and articles in contact with water for human consumption.

The term does not cover fixed public or private water supply equipment. Ensuring that what we eat is safe does not stop at testing the food itself. Everything that comes in contact with food as it is produced, packaged, transported, stored, prepared and consumed also needs to be safe. Materials such as plastics, paper and board, metals, ceramics are commonly used for the manufacturing of food packaging, but also kitchenware and cutlery and food processing equipments. The safety of such materials relies on ensuring that during contact there is no migration of unsafe levels of chemical substances from the material to the food. The European Reference Laboratory for Food Contact Materials (EURL-FCM) provides scientific and technical assistance to the EU and the Member States. It organizes interlaboratory comparison exercises and conducts training courses for the benefit of National Reference Laboratories (NRLs) and of experts from developing countries. It is supported by a Network of National Reference Laboratories. Food contact materials data base: https://webgate.ec.europa.eu/sanco_foods/main/?event=display

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2.3. 2.3.1.

Product Description

Dish washing liquids Liquid bleaches for retail Liquid detergents Other detergents Preparations for the treatment of textile materials or other materials Disinfectants

Chemicals & Non-Metallic Minerals Specific requirements Prohibition of products containing fluorinated greenhouse gases

Ozonedepleting products

Import requirem ents for seal products

Import require ments for medici nal active substan ces

Control of trade in dangero us chemical

X X

Voluntary - Eco Label…

Mktg requirement s for dangerous chemicals, pesticides and biocides

Marketing requirement s for detergents

X X X X

X X

Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B

…for lubricants

...for all purpose cleaners and sanitary cleaners

...for dishwasher detergents

...for hand dishwashing detergents

…for laundry detergents

X X X X

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2.3.1.1.

Prohibition of products containing fluorinated greenhouse gases

(Only required for aerosols for entertainment and decorative purposes containing hydrofluorocarbons)

In accordance with Regulation (EU) No 517/2014 of the European Parliament and of the Council (OJ L-150 20/05/2014), the placing in the European Union (EU) market of products and equipment listed in Annex III, with an exemption for military equipment, is prohibited from the date specified in the Annex. The prohibition shall not apply to equipment for which it has been established in ecodesign requirements adopted under Directive 2009/125/EC that due to higher energy efficiency during its operation, its lifecycle CO2 equivalent emissions would be lower than those of equivalent equipment which meets relevant eco-design requirements and does not contain hydrofluorocarbons. Legislation Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L150 20/05/2014)

2.3.1.2.

Ozone-depleting products

(Only required for products containing or relying on ozone-depleting substances)

Imports of products and equipment containing or relying on ozone-depleting substances (ODS) into the European Union are prohibited. This ban applies to imports from any country, whether or not party to the 1987 Montreal protocol on ODS. Products liable to contain ODS are, for instance: fridges, freezers, air conditioning, asthma sprays, solvents, parts of machinery and vehicles. Fire extinguishing equipment and other products based on halons may be imported under certain conditions for particular applications and subject to licensing. Legislation 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)

2.3.1.3.

Import requirements for seal products

Prohibition on imports of skins of certain seal pups Imports for commercial purposes of the following seal products into the European Union (EU) are prohibited:  Raw furskins and furskins, tanned or dressed, including furskins assembled in plates, crosses or similar forms, of whitecoat pups of harp seals and pups of hooded seals (blue-back)  Articles made of these furskins The prohibition does not apply to products resulting from traditional hunting by the Inuit people. Import requirements for seal products Regulation (EC) No 1007/2009 of the European Parliament and of the Council (OJ L-286 31/10/2009) prohibits the placing on the EU market of products from seals and other pinnipeds unless they:  result from traditional hunts conducted by Inuit and other indigenous communities and contribute to their subsistence;  result from hunts regulated under national law with the sole purpose of the sustainable management of marine resources and where the products are marketed on a non-profit basis; or

Des entrepreneurs au service des entrepreneurs are of an occasional nature, exclusively for the personal use of travelers or their families. Goods should not be of a nature or quantity to indicate that they are being imported for commercial reasons. In order to ensure the correct application of the traditional hunting and management of marine resource exceptions, the release for free circulation of the seal product is subject to the presentation of an attesting document issued by a recognized body. Seal products acquired on site in a third country by travelers and imported by them at a later date, must be accompanied by a written notification of import and a document giving evidence where the products were acquired. 

Legislation  Council Directive 83/129/EEC of 28/03/1983 concerning the importation into Member States of skins of certain seal pups and products derived therefrom (OJ L91 09/04/1983)  Regulation (EC) No 1007/2009 of the European Parliament and of the Council of 16 September 2009 on trade in seal products (OJ L-286 31/10/2009)  Commission Regulation (EU) No 737/2010 of 10 August 2010 laying down detailed rules for the implementation of Regulation (EC) No 1007/2009 of the European Parliament and of the Council on trade in seal products (OJ L-216 17/08/2010).

2.3.1.4.

Import requirements for medicinal active substances

Active substances intended to be used as raw materials in the manufacture of medicinal products can only be imported by registered authorized operators in the importing Member State. In order to be authorized, operators must meet at least the following requirements:   

specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled; have at their disposal suitable and sufficient premises, technical equipment and control facilities as regards both control and storage of these products; have at their disposal the services of at least one qualified person in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.

Active substances may only be imported provided they fulfill certain conditions:  have been manufactured in accordance with standards of good manufacturing practice;  are accompanied by a written confirmation from the competent authority of the exporting third country ensuring that the legislative provisions applicable to the manufacturing of active substances intended for export to the Union, as well as inspections of facilities and enforcement of the applicable provisions, provide for a level of protection of public health equivalent to that provided for by Union law. The written confirmation shall not be required if the exporting country is included in the list set out in Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (OJ L-325 23/11/2012). Legislation  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L-311 28/11/2001)  Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L-311 28/11/2001) Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs 

Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (OJ L-159 20/06/2012)

2.3.1.5.

Control of trade in dangerous chemicals

(Only required for mixtures and preparations containing Pentachlorophenol and its salts and esters)

Imports of certain dangerous chemicals into the European Union (EU) are banned or severely restricted and subject to control measures laid down in Regulation (EU) No 649/2012 of the European Parliament and of the Council (OJ L-201 27/07/2012), which implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade, with a view to protecting human health and the environment from potential harm and contributing to the environmentally sound use of such chemicals. These control measures are based on a standardized system of exchange of information between exporting and importing countries which allows the latter to identify potential hazards and exclude chemicals they cannot manage safely. There are two basic import procedures: Prior Informed Consent (PIC) procedure Exports of certain pesticides and industrial chemicals that have been banned or severely restricted for health or environmental reasons can only take place with the explicit prior informed consent (PIC) of the importing country. The importing country may decide whether it accepts future shipments or not, or if it consents to import these products only subject to specified conditions. Notification procedure Until the chemical becomes subject to the PIC procedure, the designated national authority (DNA) of the country that plans to export a chemical that is banned or severely restricted for use within its territory, must inform the designated national authority of the importing country that such export will take place (notification procedure) before the first shipment and annually thereafter. The European Chemicals Agency (ECHA) is the common national designated authority for the EU for all the administrative functions of the Convention: it sends and receives the export notifications from third countries, it establishes EU import decisions and submits PIC notifications. Product scope  Products included in a category of the Rotterdam Convention (i.e. pesticides or industrial chemicals) or in one of the European Union´s subcategories (i.e. pesticide used as a plant protection product, biocidal product, industrial chemical for use by professionals, industrial chemical for use by the public).  Chemicals or chemical groups that are subject to the PIC procedure according to the Rotterdam Convention. Legislation  Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L-201 27/07/2012)  Council Decision 2006/730/EC of 25 September 2006 on the conclusion, on behalf of the European Community, of the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (OJ L-299 28/10/2006)

Des entrepreneurs au service des entrepreneurs 



 



 



Communication from the Commission — Technical guidance notes for implementation of Regulation (EC) No 689/2008 — Publication made in accordance with Article 23 of Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals (OJ C-65 01/03/2011) Commission Decision 2000/657/EC of 16 October 2000 adopting Community import decisions for certain chemicals pursuant to Council Regulation (EEC) No 2455/92 concerning the export and import of certain dangerous chemicals (OJ L275 27/10/2000) Commission Decision 2001/852/EC of 19 November 2001 on adopting Community import decisions pursuant to Council Regulation (EEC) No 2455/92 concerning the export and import of certain dangerous chemicals and amending Decision 2000/657/EC (OJ L-318 04/12/2001) Commission Decision 2003/508/EC of 07 July 2003 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council and amending Decisions 2000/657/EC and 2001/852/EC (OJ L-174 12/07/2003) Commission Decision 2004/382/EC of 26 April 2004 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council (OJ L-144 30/04/2004) Commission Decision 2005/416/EC of 19 May 2005 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council and amending Decisions 2000/657/EC, 2001/852/EC and 2003/508/EC (OJ L-147 10/06/2005) Commission Decision 2005/814/EC of 18 November 2005 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 304/2003 of the European Parliament and of the Council and amending Decision 2000/657/EC (OJ L-304 23/11/2005) Commission Decision 2009/875/EC of 30 November 2009 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 689/2008 of the European Parliament and of the Council (OJ L-315 02/12/2009) Commission Decision 2009/966/EC of 30 November 2009 adopting Community import decisions for certain chemicals pursuant to Regulation (EC) No 689/2008 of the European Parliament and of the Council and amending Commission Decisions 2000/657/EC, 2001/852/EC, 2003/508/EC, 2004/382/EC and 2005/416/EC (OJ L-341 22/12/2009) Council Decision 2011/162/EU of 14 March 2011 establishing the position to be taken by the European Union within the fifth meeting of the Conference of the Parties of the Rotterdam Convention as regards the amendments to Annex III to the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (OJ L-70 17/03/2011) Commission Implementing Decision 2012/C 177/05 of 15 June 2012 adopting Union import decisions for certain chemicals pursuant to Regulation (EC) No 689/2008 of the European Parliament and of the Council (OJ C-177 20/06/2012) (CELEX 32012D0620(01)

2.3.1.1. Marketing requirements for dangerous chemicals, pesticides and biocides The placing in the European Union (EU) market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment. Hence, the provisions applicable to these products are as follows: General procedures for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs Specific provisions on the Classification, Labelling and Packaging (CLP) of substances and mixtures Specific conditions for plant protection products and biocidal products 1. Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) The EU regulatory framework for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was adopted in December 2006: Regulation (EC) No 1907/2006 of the European Parliament and of the Council (OJ L-396 30/12/2006) (CELEX 32006R1907). In principle it applies to all chemicals: not only to those used in industrial processes but also in our day-to-day life, for example in cleaning products, paints,... as well as in articles such as clothing, furniture and electrical appliances. REACH Regulation replaces several EU laws related to chemicals and is complementary to other environmental and safety legislation, but it will not replace sector specific legislation (i.e. detergents, cosmetics, biocides, etc.) The European Chemicals Agency (ECHA) is the central point in the REACH system. The Agency manages and coordinates the registration, evaluation, authorization and restriction processes of chemical substances to ensure consistency in the management of chemicals across the European Union. Registration Companies that manufacture or import one tonne or more of a chemical substance annually are required to submit a registration to a central database at ECHA. The registration procedure involves submitting a technical dossier containing information on the substance and guidance on how to handle it safely. For quantities of ten tonnes and more, companies also need to submit a Chemical Safety Report to document a safety assessment of the substance, demonstrating safe handling for all identified uses and manufacturing processes. The obligation to register applies from 1 June 2008. The Regulation foresees different deadlines depending on the type and quantity of the substances produced or imported into the EU market. Evaluation Evaluation procedures allow authorities to determine if further testing is needed and to assess whether information provided by industry complies with the requirements (dossier evaluation). Substances suspected to pose a risk to health or the environment will be selected for substance evaluation. This may lead to actions under the authorization or restrictions procedures. Authorization Substances of very high concern (carcinogens, mutagens, substances which are persistent, bio-accumulative and toxic, etc.) are subject to an authorization procedure. Companies who apply for authorization need to show that the risks posed by those substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks.

Restriction Any substance on its own, in a preparation or in an article, may be subject to restrictions if its use poses unacceptable risks to health or the environment. Restrictions can be imposed on the use of a substance in certain circumstances and products, on the use by consumers or even on all uses (complete ban of a substance).

Des entrepreneurs au service des entrepreneurs Restrictions apply to all manufacturers, importers, downstream users and distributors of a substance if the manufacture, use or placing in the market of this substance is listed in Annex XVII. Under this Regulation, the burden of proof for demonstrating the safe use of chemicals is transferred from Member States to the industry in order to ensure that the risks to human health and environment are avoided or adequately controlled. 2. Classification, Labelling and Packaging (CLP) of substances and mixtures Additionally, Regulation (EC) No 1272/2008 of the European Parliament and of the Council (OJ L-353 31/12/2008) (CELEX 32008R1272) on Classification, Labelling and Packaging (CLP) of substances and mixtures requires companies to classify, label and package their chemicals before placing them on the EU market. The scope of this Regulation covers chemical substances and mixtures which are composed of two chemical substances or more, but it shall not apply to medicinal products, cosmetic products, medical devices, waste, foodstuffs, radioactive substances, etc. The CLP Regulation introduces throughout the EU a new system based on the United Nations Globally Harmonized System (GHS ) which sets up the classification of chemicals according to their hazardous properties and defines the pictograms and other notices which must appear on the label. The provisions of CLP will gradually replace previous legislation (Council Directive 67/548/EEC on dangerous substances and Directive 1999/45/EC on dangerous preparations) in a stepwise approach until 1 June 2015. The Regulation also takes over certain provisions of Regulation (EC) No 1907/2006 (REACH) regarding the notification of classifications to the European Chemicals Agency (ECHA), the establishment of a list of harmonized classifications and the creation of a classification and labelling inventory. Classification The classification is based on categories defined in the Annex VI to the Regulation according to the degree of hazard and the specific nature of the hazardous properties. These categories include explosives, inflammable substances or mixtures, those which are highly toxic, those which are dangerous for the aquatic environment, etc. The criteria for the classification and labelling of hazardous substances and mixtures is established in Annex I (i.e. physical, health, environmental hazards and other EU additional hazards class). Labelling A substance or mixture classified shall bear a label including the following elements:    

Name of the substance or mixture and/or an identification number; Name, address and telephone number of the supplier; Nominal quantity of the substance or mixture. Labelling must also include, if applicable:

The signal words “Danger” for the severe hazard categories or “Warning” indicating the less severe hazard; Hazard pictograms that shall be in the shape of a square set at a point and shall cover at least one fifteenth of the surface area of the harmonized label and the minimum area shall not be less than 1 cm2 (Annex V); Hazard statements (such as “Fire or projection hazard”, “Fatal if swallowed”, etc.) and supplemental information according to the specific category (Annex III); Precautionary statements (Annex IV). Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs This information shall be located together on the label in an order established by the supplier, provided that the statements are grouped by language. The label for the hazardous substance or mixture shall be written in the official language(s) of the Member State where it is placed on the market, unless the Member State concerned provides otherwise. The dimensions of the label will depend on the capacity of the package. Packaging Packaging containing hazardous substances or mixtures shall comply with the following requirements: -

Packaging must prevent any loss of the contents, except where special safety devices are prescribed; Materials constituting the packaging must be resistant if they come into contact with the contents; Packaging must be strong and solid and have sealable fastenings. In some cases, child-resistant fastenings and tactile warnings are required.

EU legislation on Classification, Labelling and Packaging (CLP) of substances and mixtures List of additional information sources on Classification, labelling and packaging (CLP) of substances and mixtures 3. Specific conditions for plant protection products and biocidal products Plant protection products Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ L-309 24/11/2009) lays down the rules for the authorization of plant protection products in commercial form, the approval of their active substances as well as the rules for their placing on the market, use and control within the EU. Plant protection products are preparations consisting of or containing active substances (chemical elements or micro-organisms, including viruses), antidotes or synergists, and intended for one of the following uses: 

   

protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products; influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient; preserving plant products; destroying undesired plants or parts of plants; checking or preventing undesired growth of plants.

These products are subject to the following conditions:



Procedure and criteria for the approval active substances:

An active substance will be approved if it fulfils the procedure and criteria detailed in Annex II to the Regulation. These criteria relate to the efficacy of the substance, the Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs relevance of metabolites, its composition, the methods of analysis, the impact on human health and the environment, ecotoxicology and residues. Initially, the first approval is valid for a limited period which cannot exceed ten years and may be subject to certain conditions or restrictions regarding, for example, the purity of the active substance, the intended crop and the category of user. Active substances which have been approved may be consulted on the EU Pesticide database of the European Commission - DG Health and Consumer Protection website: http://ec.europa.eu/sanco_pesticides/public/index.cfm Authorisation for placing on the market of plant protection products: A plant protection product will be authorised if its active substances have been approved and the specific conditions established in the Regulation (EC) No 1107/2009 and the uniform principles for evaluation laid down in Commission Regulation (EU) No 546/2011 (OJ L-155 11/06/2011) (CELEX 32011R0546) are fulfilled. Applications are submitted to the Member State where the product is intended to be placed on the market and will be accompanied by two dossiers containing all the information available to enable the potential effects of product on human and animal health, and the possible impact on the environment, to be assessed. Certain information provided by the applicant may be kept confidential if it provides verifiable evidence that undermines his commercial interests. A provisional authorisation for a period not exceeding three years may be granted for plant protection products containing an active substance not yet approved, is also covered by Regulation (EC) No 1107/2009. In addition, the provisions of mutual recognition establish that the holder of an authorisation granted in a Member State may apply for an authorisation for the same plant protection products, the same use and under comparable agriculture practices in another Member State.



Packaging and labelling of plant protection products:

The labelling of plant protection products must comply with the requirements set out in Annex I to Commission Regulation (EU) No 547/2011 (OJ L-155 11/06/2011) (CELEX 32011R0547) and contain the standard phrases on special risks and safety precautions to protect human or animal health or to the environment. The products that may be mistaken for food, drink or feed must be packaged in such a way as to minimise the likelihood to be mistaken and contain components to discourage or prevent their consumption. Moreover, the provisions on classification, labelling and packaging (CLP) of substances and mixtures laid down by Regulation (EC) No 1272/2008 of the European Parliament and of the Council (OJ L-353 31/12/2008) (CELEX 32008R1272) are also applicable to plant protection products. 

Official control and emergency measures

Member States will carry out official controls in order to enforce compliance with the conditions established in Regulation (EC) No 1107/2009. The European Commission may adopt emergency measures in order to restrict or prohibit the use and/or sale of an approved active substance or a plant protection product if it is Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs likely to constitute a serious risk to human or animal health or the environment and that such risk cannot be contained satisfactorily by the Member State(s) concerned Biocidal products The biocidal products Regulation (BPR, Regulation (EU) No 528/2012) concerns the placing in the market and use of biocidal products within the EU. A biocidal product is any active substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. The scope of BPR covers 22 different product types listed in Annex V (including disinfectants, chemicals used for preservation of products and materials, non-agricultural pesticides and anti-fouling products used on hulls of vessels) and articles treated with biocidal products (e.g. furniture treated with wood preservatives, textiles, etc.). Other products that are sufficiently covered by existing EU legislation (medicinal products, medical devices, food and feed, additives, flavourings, cosmetic products, toys, plant protection products) are excluded from the scope of BPR. Authorisation of biocides The following conditions must be met for authorization of biocidal products:     

the active substances are approved for the relevant product-type; the biocidal product, when used as authorized, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment; the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product; where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product; where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

All biocidal products must get an authorization before they can be made available in the market. Companies can choose between several alternative procedures, depending on their product and the number of countries where they wish to sell it:   

National authorization and mutual recognition: Once first authorization is granted by an EU country, the applicant can ask for the recognition of that authorization by other EU countries; Union authorization: This procedure allow companies to place certain biocidal products directly in the entire EU market; Simplified authorization: To be eligible for this procedure the biocide must comply with the following conditions:  All the active substances contained in the product appear in Annex I of the BPR and satisfy the specific restrictions;  It does not contain any substance of concern or any nanomaterials;  It is sufficiently effective;  Its handling and intended use do not require personal protective equipment.

Approval of active substances Companies have to apply for approval of an active substance by submitting a dossier (complying with the requirements of Annex II to BPR) to European Chemicals Agency (ECHA). After the validation check has been performed, the evaluating competent Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs authority carries out a completeness check and an evaluation within one year. The approval of an active substance is granted for a defined number of years, not exceeding ten years. BPR also provides that substances included in Annex I to Directive 98/8/EC (previous legislation) will be included in the list of approved substances to be kept up to date by the European Commission. Labelling and packaging Companies will ensure that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications. In addition, the label must show clearly and indelibly the following information: The type of formulation, the identity of every active substance and its concentration; The authorization number, the identification (name and address) of the authorization holder; Directions for use, frequency of application and dose rate in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorization; Particulars of likely direct or indirect adverse side effects and any directions for first aid; Directions for the safe disposal of the biocidal product and its packaging. The provisions relating to the classification, labelling and packaging (CLP) of substances and mixtures laid down by Regulation (EC) No 1272/2008 (CLP) are also applicable. Beside, BPR provides for a simplified procedure for granting auhorisation to very similar products which only vary in terms of relatively minor differences in composition and have the same use and user type (Product family).

2.3.1.2.

Marketing requirements for detergents

The placing in the European Union (EU) market of detergents and surfactants for detergents must comply with specific provisions laid down in Regulation (EC) No 648/2004 of the European Parliament and of the Council (OJ L-104 08/04/2004) designed to ensure a high level of environmental protection, especially of the aquatic environment, and human health. Detergent means any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning processes. They may be in any form (liquid, powder, paste, cake, etc.) and marketed for used in household, or institutional or industrial purposes. Hence, these products are affected by provisions concerning more particularly:  Marketing limitations based on the biodegradability of surfactants  Labelling and mandatory product information  Control and safeguard measures In addition, certain surfactants used as disinfectants may be subject to the provisions laid down in Directive 98/8/EC of the European Parliament and of the Council (OJ L-123 24/04/1998) concerning the placing of biocidal products in the EU market. Marketing limitations based on the biodegradability of surfactants Only the surfactants and detergents containing surfactants that meet the criteria for biodegradation as laid down in Annex III of Regulation (EC) No 648/2004 of the European Parliament and of the Council may be placed in the EU market without further limitations relating to biodegradability. Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs However, if an industrial or institutional detergent contains surfactants for which the level of bio-degradation is lower than the stipulated in Annex III but meet the biodegradability criteria of Annex II the person responsible for the placing the product on the market may ask for derogation in accordance with a uniform procedure set out in the Regulation. The list of surfactants that have obtained derogation, with the corresponding conditions or limitations of use, is included in Annex V. Labelling and mandatory product information Those responsible for the placing of a detergent in the market must, upon request, make available without delay and free of charge, to healthcare professionals (medical personnel and/or specific public body) in the Member State an ingredient datasheet. This information will be kept confidential and will be used only for medical purposes. The following information must appear in legible, visible and indelible characters on the packaging in which the detergents are put up for sale to the consumer:  the name and trade name of the product;  the name or trade name and full address and telephone number of the party responsible for placing the product on the market;  the address, email, where available, and telephone number of the specific public body from which the ingredient datasheet can be obtained. Specifications on the content, instructions for use, special precautions and dosage instructions must be also indicated on the packaging of detergents and cleaning products and laundry detergents. The same information must appear on all documents accompanying detergents transported in bulk. Besides this information, the provisions relating to the classification, labelling and packaging (CLP) of substances and mixtures laid down by with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (OJ L-353 31/12/2008) are also applicable to detergents and surfactants classified as hazardous. Control and safeguard measures Member States’ competent authorities may apply, as appropriate, all necessary control measures to detergents placed in the market which ensure the compliance of the product with the provisions of this Regulation. If a Member State has justifiable grounds for believing that a specific detergent constitutes a risk to safety or health of humans or of animals or a risk to the environment, it may temporarily prohibit the placing on the market of that detergent in its territory or make it temporarily subject to special conditions. Legislation  Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L-104 08/04/2004)  Updated list of approved laboratories that according to Article 8(2) of Regulation (EC) No 648/2004 of the European Parliament and of the Council on detergents are competent to carry out the tests required by the Regulation (OJ C-39 18/02/2009)

2.3.1.3.

Eco-label

The Community Eco-label or "Flower logo" is the official mark in the European Union (EU) for products with the lowest environmental impact in a product range. Its aim is to promote, as well as to help consumers to identify those products which contribute significantly to improvements in relation to key environmental aspects.

Des entrepreneurs au service des entrepreneurs Participation on the scheme is voluntary. This means that products can be sold within the EU market without the Flower logo and that there are no regulations which oblige to apply for the Eco-label.

General Procedure (applied to all Eco-label mentioned) When a product is included in the product group definition and complies with the published Eco-label criteria, manufacturers, importers, service providers, trader or retailers who want to market their products in the EU, may apply for the Eco-label in accordance with Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Eco-label (OJ L-27 30/01/2010) For a product made outside the European Community, the application must be presented to a Competent Body of any of the Member States in which the product is to be or has been placed on the market. The application must include all relevant documentation to prove that the product complies with the ecological and performance criteria. The Competent Body will inform the applicant of the necessary documents that need to be submitted, the test results that must be provided, how they should be carried out, etc. After assessing whether the product conforms to the Eco-label criteria and that the application complies with the assessment and verification requirements set out in Commission Decision 2011/381/EU, the Competent Body will decide on the award the label. If the application is successful the Competent Body will conclude a contract with the applicant covering the terms of use of the label. Eco-labelled products can be marketed in all Member States. Once obtained, the holder has the choice of displaying the Flower logo on any part of the product. It can be used from the date it is awarded until the end of the period of validity of the criteria. Applications for the award of an Eco-label are subject to payment of a fee. In addition, there is an annual fee for the use of the label. Specific requirements are described in the following table:

Des entrepreneurs au service des entrepreneurs

Eco label

For lubricants

Product Scope

Requirements

According to Commission Decision 2011/381/EU (OJ L-169 29/06/2011) the product group ‘lubricants’ comprises:  Hydraulic fluids and tractor transmission oil  Greases and stern tube greases  Chainsaw oils, concrete release agents, wire rope lubricants, stern tube oils and other total loss lubricant  Two-stroke oil  Industrial and marine gear oil

In order to be awarded the Community Ecolabel, lubricants must comply with the criteria set out in the Annex to Commission Decision 2011/381/EU referring to:  Excluded or limited substances and mixtures  Exclusion of specific substances  Additional aquatic toxicity requirements  Biodegradability and bioaccumulative potential  Renewable raw materials  Minimum technical performance  Information appearing on the eco-label The end of the period of validity of the criteria for lubricants will be 24 June 2015.

Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B

Legislation

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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) Commission Decision 2011/381/EU of 24 June 2011 on establishing the ecological criteria for the award of the EU Ecolabel to lubricants (OJ L-169 29/06/2011)

Des entrepreneurs au service des entrepreneurs

For all purpose cleaners and sanitary cleaners

According to Commission Decision 2011/383/EU (OJ L169 29/06/2011) the product group ‘all purpose cleaners and sanitary cleaners comprises all-purpose cleaners, window cleaners and sanitary cleaners for private and professional use.

In order to be awarded the Community Ecolabel, all purpose cleaners and sanitary cleaners must comply with the criteria set out in the Annex to Commission Decision 2011/383/EU referring to:  Toxicity to aquatic organisms  Biodegradability of surfactants  Excluded or limited substances and mixtures  Fragrances  Volatile organic compounds  Phosphorus  Packaging requirements  Fitness for use  User instructions  Information appearing on the eco-label  Professional training



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) Commission Decision 2011/383/EU of 28 June 2011 on establishing the ecological criteria for the award of the EU Ecolabel to allpurpose cleaners and sanitary cleaners (OJ L-169 29/06/2011)

The end of the period of validity of the criteria will be 31 December 2016. 

For dishwasher detergents

Domestic dishwasher detergents.- Domestic dishwasher detergents (Commission According to Commission Decision Decision 2011/263/EU): 2011/263/EU (OJ L-111 30/04/2011) the  Total chemicals product group ‘detergents for dishwashers’  Excluded or limited substances or comprises detergents for dishwashers and mixtures products used as rinse aids, whether in  Toxicity to aquatic organisms: Critical powder, liquid or any other form, which are Dilution Volume intended to be marketed and used  Biodegradability of organics exclusively in automatic domestic  Washing performance

Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B



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) Commission Decision 2011/263/EU of 28 April 2011 establishing the ecological criteria for the award of the EU Ecolabel to detergents for dishwashers (OJ L-111 30/04/2011)

Des entrepreneurs au service des entrepreneurs dishwashers and in automatic dishwashers for professional use, the size and usage of which is similar to that of domestic dishwashers. Industrial dishwasher detergents.- According to Commission Decision 2012/720/EU (OJ L326 24/11/2012) the product group ‘Industrial and Institutional Automatic Dishwasher Detergents’ comprise single and multicomponent dishwasher detergents, rinse and presoaks, designed for use in professional dishwashers.

 Packaging requirements  Consumer information  Information appearing on the eco-label The end of the period of validity of the criteria for domestic detergents for dishwashers will be 31 December 2016.

According to Commission Decision 2011/382/EU (OJ L-169 29/06/2011) the product group ‘hand dishwashing detergents’ comprises all detergents intended to wash by hand, dishes, crockery, cutlery, pots, pans and other kitchen utensils, etc. both for private and professional use.

In order to be awarded the Community Ecolabel, hand dishwashing detergents must comply with the criteria set out in the Annex to Commission Decision 2011/382/EU referring to:  Toxicity to aquatic organisms  Biodegradability of surfactants



For hand dishwashing detergents



Commission Decision 2012/720/EU of 14 November 2012 establishing the ecological criteria for the award of the EU Ecolabel for Industrial and Institutional Automatic Dishwasher Detergents (OJ L-326 24-11-2012)



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) Commission Decision 2011/382/EU of 24 June 2011 on establishing the ecological criteria

Industrial dishwasher detergents (Commission Decision 2012/720/EU):  Toxicity to a aquatic organism: Critical Dilution Volume (CDV)  Biodegradability  Excluded or limited substances and mixtures  Packaging requirements  Washing performance (fitness for use)  Automatic dosing systems  User information - Information appearing on the eco-label  Information appearing on the eco-label The end of the period of validity of the criteria for industrial detergents for dishwashers will be 14 November 2016.

Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B



Des entrepreneurs au service des entrepreneurs Excluded or limited substances and mixtures  Fragrances  Corrosive properties  Packaging requirements  Fitness for use  User instructions  Information appearing on the eco-label The end of the period of validity of the criteria for hand dishwashing detergents will be 31 December 2016.

for the award of the EU Ecolabel to hand dishwashing detergents (OJ L-169 29/06/2011)



For laundry detergents 

Domestic laundry detergents.- According to Commission Decision 2011/264/EU (OJ L-111 30/04/2011) the product group ‘laundry detergents’ comprises laundry detergents and pre-treatment stain removers whether in powder, liquid or any other form which are marketed and used for the washing of textiles principally in household machines but not excluding their use in launderettes and common laundries. Industrial laundry detergents.- According to Commission Decision 2012/721/EU (OJ L-326 24/11/2012 the product group ‘Industrial and Institutional Laundry Detergents’ comprise laundry detergent products performed by professional users in the industrial and institutional sector

In order to be awarded the EU Ecolabel, detergents for dishwashers must comply with the criteria set out in the Annexes of the Commission Decisions. Domestic laundry detergents (Commission Decision 2011/264/EU):  Dosage requirements  Toxicity to aquatic organisms: Critical Dilution Volume (CDV)  Biodegradability of organics  Excluded or limited substances and mixtures  Packaging requirements  Washing performance (fitness for use)  Points to achieved in order to be awarded EU eco-label  Information appearing on the eco-label

Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B



 

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) Commission Decision 2011/264/EU of 28 April 2011 establishing the ecological criteria for the award of the Community Ecolabel to laundry detergents (OJ L-111 30/04/2011)

Des entrepreneurs au service des entrepreneurs The end of the period of validity of the criteria for laundry detergents will be 31 December 2016. Industrial laundry detergents (Commission Decision 2012/721/EU):  Product and dosage requirements  Toxicity to aquatic organisms: Critical Dilution Volume (CDV)  Biodegradability  Excluded or limited substances and mixtures  Packaging requirements  Washing performance (fitness for use)  Automatic dosing systems  Consumer information  Information appearing on the eco-label The end of the period of validity of the criteria for industrial laundry detergents will be 14 November 2016.

Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B

Des entrepreneurs au service des entrepreneurs

2.4. 2.4.1.

Paper, Printing, Packaging and Publishing Specific requirements for plastic bottles

2.4.1.1.

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. European Parliament and Council Directive 94/62/EC (OJ L-365 31/12/1994) defines "packaging" as every product made of any material of any nature to be used for the containment, protection, handling, delivery and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer. "Nonreturnable" items used for the same purposes are also considered to constitute packaging. The Directive contains a list of illustrative examples of "packaging” and "nonpackaging" products affected by:    

General requirements related to packaging and packaging waste Specific provisions related to package sizing Specific rules on nominal quantities for prepacked products Special rules for materials and articles intended to come into contact with foodstuffs

General requirements related to packaging and packaging waste All packaging placed in the EU market, including packaging designed for industrial, commercial and domestic purposes, must comply with the essential requirements on the composition and the heavy metals limits specified in European Parliament and Council Directive 94/62/EC, aiming at minimising the impact of packaging waste on the environment. The essential requirements which are set forth in Annex II to the Directive relate to:  Waste reduction by minimising the weight and/or volume of packaging;  Minimising the presence of substances considered to be noxious or hazardous;  Nature and conditions for packaging to be reused;  Recovery of packaging by material recycling and/or composting and/or energy recovery. 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). In relation to wood packaging, the provisions introduced by Commission Directive 2004/102/EC (OJ L-309 06/10/2004) 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. Companies responsible for placing packaging on the EU market must ensure that the essential requirements are met. However, packaging is presumed to comply with these requirements if the packaging comports with harmonised standards that are first adopted by CEN (European Committee for Standardisation), and then approved and published by the European Commission. Nowadays, six CEN standards have been published in the Official Journal. The heavy metal limits apply to cadmium, mercury, lead and hexavalent chromium. The total level of these metals in packaging or packaging components must not exceed 100 Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs parts per million (ppm). Packaging entirely made of lead crystal glass is exempted from the application of heavy metal concentration levels. Packaging must bear the appropriate marking on the packaging itself or on a label, in particular, the nature of the packaging materials used must be indicated. Commission Decision 97/129/EC (OJ L-50 20/02/1997) establishes a Packaging Material Identification System to facilitate identification and classification of packaging materials. Specific provisions on package sizing Certain prepackaged products shall only be placed on the market provided the nominal quantity and capacity of the container fits into one of the sizes permitted by the EU legislation. The labelling must indicate the volume in the case of liquid products and the weight in the case of other products. The label of the prepacked product must also bear the weight and volume indications used in trade practice or comply with the national regulations of the destination country. The packaging of these goods must bear specific inscriptions and markings such as the identification of the packer, the person responsible for the packing or the importer established in the EU, and the EEC mark, a small 'e', that must be placed in the same field of vision as the indication of the nominal volume or weight of the contents. This EEC marking symbolizes the conformity with the metrological requirements laid down by Council Directive 76/211/EEC, in order to ensure that consumers get indeed the quantity indicated on the packaging. Specific rules on nominal quantities for prepacked products Directive 2007/45/EC of the European Parliament and of the Council (OJ L-247 21/09/2007) establishes the range of nominal quantities for prepacked products. According to this scheme:  Member States shall ensure that products listed in section 2 of the Annex to Directive 2007/45/EC and put up in prepackages in the intervals listed in section 1 of the Annex, are placed on the market only if they are prepacked in the nominal quantities listed in section 1.  Aerosol dispensers shall indicate the nominal total capacity of the container, avoiding any confusion with the nominal volume of the contents. Such dispensers will not need to be marked with the nominal weight of their contents.  The nominal quantities listed in section 1 of the Annex shall apply to each individual prepackage when two or more individual prepackages make up a multipack, as well as to the prepackage when it is made up of two or more individual packages which are not intended to be sold individually. Special rules for materials and articles intended to come into contact with foodstuffs All materials and articles intended to come into contact with foodstuffs, including packaging materials and containers, must be manufactured so that they do not transfer their constituents to food in quantities that could endanger human health, change the composition of the food in an unacceptable way or deteriorate the taste and odour of foodstuffs. Regulation (EC) No 1935/2004 of the European Parliament and of the Council (OJ L-338 13/11/2004) establishes a list of materials and articles (such us plastics, ceramics, rubbers, paper, glass, etc.) which may be subject to specific measures related to authorized substances, special conditions of use, purity standards, etc. Currently specific measures exist for ceramics, regenerated cellulose and plastics. This Regulation also lays down that these products will be labelled "for food contact" or shall bear the symbol with a glass and fork. Commission Regulation (EC) No 2023/2006 (OJ L-384 29/12/2006) lays down the rules on good manufacturing practice (GMP) for the groups of materials and articles intended to Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs come into contact with food listed in Annex I to Regulation (EC) No 1935/2004 of the European Parliament and of the Council and combinations of those materials and articles or recycled materials and articles used in their manufacturing process. According to this Regulation, the application of printing inks to the non-food contact side of a material or article is subject to specific rules. Furthermore, and following the scope of both Regulations above mentioned, several EU Regulations have laid down specific conditions applicable to the placing in the EU market of plastic materials and articles intended to come into contact with food:  Recycled plastics used to manufacture materials and articles intended for food contact shall be obtained only from processes authorized by the Commission following a safety assessment performed by the European Food Safety Authority (EFSA) according to Commission Regulation (EC) No 282/2008 (OJ L-86 28/03/2008).  The recycling process shall also be managed by a quality assurance system (QAS) that should meet the requirements laid down in the Annex of Commission Regulation (EC) No 2023/2006.  Only the substances included in the Union list of authorized substances set out in Commission Regulation (EU) No 10/2011 (OJ L-12 15/01/2011) may be used for the manufacture of these products. In addition, according to this Regulation, from 1 June 2011, the marketing and importation into the Union of plastic materials and articles intended to come into contact with foodstuffs containing Bisphenol A (BPA) is temporarily banned.  Polyamide and melamine plastic kitchenware originating in or consigned from China and Hong Kong shall be imported into the Member States only if the importer submits to the competent authority for each consignment a declaration confirming that it meets the requirements concerning the release of primary aromatic amines and formaldehyde laid down in Annex II to Commission Regulation (EU) No 10/2011, according to Commission Regulation (EU) No 284/2011 (OJ L-77 23/03/2011)

2.4.1.2.

Technical standards for in vitro diagnostic medical devices

The placing of in vitro medical devices on the European Union (EU) market is subject to the compliance with the essential requirements established by Directive 98/79/EC of the European Parliament and of the Council (OJ L-331 07/12/1998) in order to ensure a high level of protection of the health and safety of patients, users and third parties and achieve the intended level of performance. Product scope Directive 98/79/EC of the European Parliament and of the Council applies to in vitro diagnostic medical devices and their accessories. These devices are products to be used for the in vitro analysis of tissues or substances (blood, specimens) from the human body with the objective of:  providing information of the state of health or congenital diseases or anomalies  determining the compatibility in the case of organ or blood donations  monitoring therapeutic measures. Examples of in vitro diagnostic medical devices are equipment for blood analysis, pregnancy tests, laboratory equipment intended for in vitro diagnostic examination, etc. Products for general laboratory use are excluded. 1. Essential requirements The medical devices must meet the mandatory essential requirements set out in Annex I to the Directive in such a way that their design, manufacture and packaging minimise any risks to the safety and health of patients, users and third parties when they are used for their intended purpose. These requirements refer to issues such as chemical and physical properties (e.g. compatibility between the materials and the specimens), environmental properties, Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs sterilization, accuracy of devices with a measuring function, labelling or instructions for use. In particular the label must bear the following particulars: a) the name and address of the manufacturer; b) the details strictly necessary for the user to identify the device and the contents of the packaging; c) where appropriate, the word 'STERILE'; d) where appropriate, the batch code, preceded by the word 'LOT', or the serial number; e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and the month; f) in case of devices for performance evaluation, the words 'for performance evaluation only' g) where appropriate, a statement indicating the in vitro use of the device; h) any special storage and/or handling conditions; operating instructions; warnings and/or precautions to take; i) year of manufacture for active devices; j) where applicable, method of sterilization; k) if the device is intended for self-testing, that fact must be clearly stated. The essential requirements cover risks such as injuries, infection and microbial contamination, radiation, electromagnetic disturbances, environmental risks, electrical risks, mechanical and thermal risks, risks of fire and explosion, etc. 2. Harmonized standards Harmonized standards are technical specifications that would enable to meet the essential requirements. Products manufactured according to these harmonized standards benefit from a presumption of compliance with the essential requirements. Harmonized standards are developed by the European Standardization bodies: CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization). These bodies are independent organizations whose mission is to develop respectively voluntary technical and electrotechnical standards, in order to promote free trade in the single European Market. The standards are published in the Official Journal of the European Communities and transposed into national legislation in the form of national standards with identical characteristics. 3. Conformity assessment procedure The conformity of most products falling under the scope of this Directive can be assessed by the manufacturer himself since they do not constitute a direct risk to patients. The manufacturer must draw up a document (EC declaration of conformity) declaring that the products concerned meet the essential requirements of the Directive. He must also prepare the technical documentation described in Annex III and ensure that the manufacture follows the principles of quality assurance. Categories of products included in Annex II (e.g. products used in blood transfusion, identification of AIDS, measurement of blood sugar, etc.) need the intervention of a third party (Notified Body) at the design and production stages. The procedures vary according to the classification (Class A or B) of the product. Devices for self-testing by the user always require an examination of the design by a Notified Body, even if they are not included in Annex II. Notified bodies are organizations designated by each Member State and notified to the Commission and the other Member States, that are in charge of assessing manufacturer's conformity to the essential requirements when a third party is required. 4. CE marking Devices considered to meet the essential requirements must bear the CE marking of conformity when they are placed on the market. It must appear in a visible, legible and indelible way on the device or its pack and on the instructions for use. The CE marking

Des entrepreneurs au service des entrepreneurs shall be accompanied by the identification number of the notified body in charge of the conformity assessment procedure, where the intervention of a third party is needed. Devices to be used as testing material in performance evaluation studies shall not bear the CE marking. They must be accompanied by a statement drawn up by the manufacturer declaring that the product fulfils the essential requirements of the Directive. The contents of this statement are detailed in Annex VIII.

5. Other obligations A. Registration of representatives and devices Any manufacturer who places these devices on the EU market and does not have a registered place of business in a Member State, must designate an authorized representative within the European Union. The authorized representative must register with the competent authorities of the Member State in which he is established. B. Notification of putting into service Member States may request further information on devices covered by Annex II and on devices for self-testing when they are put into service within their territory (data allowing identification together with the label and the instructions). 6. Market surveillance Each Member State establishes authorities to be responsible for checking that devices placed on the market meet the requirements of the Directive and that the affixing and use of the CE marking is correct. In case a Member State finds that the CE marking has been affixed unduly, the manufacturer or his authorized representative established within the EU must make the product conform to the essential safety requirements. Otherwise, the Member State must restrict or forbid the placing on the market of those devices which are liable to endanger the health and/or safety of patients, users and third parties. Member States customs authorities shall also control the conformity of the devices to the essential requirements at the points of entry into the EU. Legislation  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L-331 07/12/1998)  Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L-131 16/05/2002)

2.4.2.

Specific requirements for article of paper pulp

2.4.2.1.

Control on illegal timber and timber products

(Only applicable to pulp and paper with the excepcion of bamboo-based and recovered (waste and scrap) products)

Des entrepreneurs au service des entrepreneurs

The placing in the EU market of illegally harvested timber and their derived products is prohibited. Moreover, operators marketing timber and timber products on the EU for the first time will have to comply with obligations laid down by Regulation (EU) No 995/2010 of the European Parliament and of the Council (OJ L-295 12/11/2010). Product scope This Regulation applies to timber and their derived products listed in Annex thereto, which are placed on the market from 3 March 2013 in the course of a commercial activity. The products listed below are excluded from the scope of this Regulation:  Recycled products obtained from timber and timber products which have completed their lifecycle, and would otherwise be disposed of as waste.  Packaging materials used exclusively to support, protect or carry another product. Besides, the following products will not have to comply with the requirements of this Regulation, since they will be considered to have been legally harvested, when presenting:  A CITES certificate for timber of species listed in Council Regulation (EC) No 338/97 on protection of species of wild fauna and flora by regulating trade therein (CITES) (OJ L-61 03/03/1997)  A FLEGT license according to Council Regulation (EC) 2173/2005 on the establishment of a FLEGT licensing scheme for imports of timber into the European Community (OJ L-347 30/12/2005). Obligations of operators 1. Operators shall apply the due diligence system to each specific type of timber or timber product and supplier. The due diligence system must be based on:  Information: measures and procedures providing access to the key information concerning the operator's supply of timber and timber products placed on the market, in order to conduct a full risk assessment.  Risk assessment: procedures enabling the operator to analyze and evaluate the risk of illegally harvested timber products being placed on the market based on the information identified above and taking into account criteria set out in this Regulation.  Risk mitigation: a set of measures and procedures that are adequate and proportionate to minimize effectively a risk, except where the risk identified is negligible. 2. Traders have to maintain traceability of timber and timber products throughout the supply chain. They must keep the information for at least five years. Operators can decide whether they use their own due diligence system or the system provided by a monitoring organization. Monitoring organizations will be recognized by EU Commission and will have to provide operators their due diligence system as well as verify the proper use of the system by operators. If operators decide to use their own system, they may use a certification or other thirdparty verified schemes as basis of their risk assessment and mitigation procedures. In addition, they must maintain and regularly evaluate the due diligence system they use. The competent authorities of the Member States shall carry out checks at regular intervals in order to verify that the monitoring organizations continue to fulfil their functions and shall carry out checks to verify if operators comply with the requirements laid down by the applicable legislation. Legislation

Des entrepreneurs au service des entrepreneurs  



Regulation (EC) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down obligations of operators who place timber and timber products on the market (OJ L-295 12/11/2010) Commission Delegated Regulation (EC) No 363/2012 of 23 February 2012 on the procedural rules for the recognition and withdrawal of recognition of monitoring organizations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down obligations of operators who place timber and timber products on the market (OJ L-115 27/04/2012) Commission Implementing Regulation (EC) No 607/2012 of 6 July 2012 on the detailed rules concerning the due diligence system and the frequency and nature of the checks on monitoring organizations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down obligations of operators who place timber and timber products on the market (OJ L-177 07/07/2012)

2.4.2.2.

Eco-label for tissue paper products

The general procedure applied here (“Flower logo”). Product scope According to Commission Decision 2009/568/EC (OJ L-197 29/07/2009) the product group ‘tissue paper products’ comprises sheets or rolls of tissue paper fit for use for personal hygiene, absorption of liquids and cleaning of soiled surfaces. The tissue product consists of crepe or embossed paper in one or several plies. The fibre content of the product shall be at least 90 %. The following products are excluded  wet wipes and laminated tissue products  tissue products laminated with other materials than tissue paper  cosmetic products Requirements In order to be awarded the Community Eco-label, tissue paper products must comply with the criteria set out in the Annex to Commission Decision 2009/568/EC referring to:  Emissions to water and air  Energy use  Fibres-sustainable forest management  Hazardous chemical substances  Product safety  Waste Management  Fitness for use  Consumer information The end of the period of validity of the criteria for tissue paper products will be 30 June 2015. Legislation  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).  Commission Decision 2009/568/EC of 9 July 2009 establishing the ecological criteria for the award of the Community Eco-label for tissue paper (OJ L-197 29/07/2009).  Commission Decision 2001/405/EC of 4 May 2001 establishing ecological criteria for the award of the Community eco-label for tissue paper products (OJ L-142 29/05/2001).

Des entrepreneurs au service des entrepreneurs

2.5. 2.5.1.

Articles of Base Metal Specific requirements for Iron, Steel, Aluminum and articles thereof

Product Description Aluzinc roofing sheets, floor decking Aluminum profiles Aluminium windows, doors, louvres

2.5.1.1.

Technical specifications for construction products

Technical standards for motor vehicles

Prohibition of products containing fluorinated greenhouse gases

Technical specifications for construction products

(Only required for products intended for construction)

From 1 of July 2013 construction products can only be placed in the European Union (EU) market if they fulfil the requirements established by Regulation (EU) No 305/2011 (OJ L-88 04/04/2011). The Regulation lays down the basic requirements for the construction works. Construction products should comply with the basic requirements in order to be incorporated in a construction work. The Construction Products Regulation (CPR) lays down harmonized conditions for the marketing of construction products and repeals Directive 89/106/EEC. Scope of application CPR applies to construction products, meaning any product or kit which is produced and placed on the market for incorporation in construction works in a permanent manner, including both buildings and civil engineering works. Basic requirements of works and essential characteristics of products Basic requirements do not refer to construction products but to construction works in which these products are to be incorporated. Construction products must be suitable for works which satisfy basic requirements set out in Annex I to the Regulation:  Mechanical resistance and stability  Safety in case of fire  Hygiene, health and the environment  Safety and accessibility in use  Energy economy and heat retention  Sustainable use of natural resources The basic requirements constitute the basis for the preparation of standardisation mandates and harmonised technical specifications. The essential characteristics of construction products are laid down in harmonised technical specifications in relation to the basic requirements for construction works. Harmonised technical specifications The harmonised technical specifications for constructions products include the Harmonised European Standards, generally for traditional construction products and European Assessment Documents (EADs), usually for innovative products. Declaration of Performance (DoP) The Declaration of Performance (DoP) should be issued by the manufacturer if the product is placed on the market and it is covered by a harmonised standard or conforms to a European Technical Assessment (ETA). The DoP expresses the performance of construction products in relation to the essential characteristics of those products in accordance with the relevant harmonised technical specifications. By drawing up the Declaration of Performance, the manufacturer assumes responsibility for the conformity of the construction product with such declared performance. Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs The Declaration of Performance shall be drawn up using the model set out in Annex III. CE marking The same as previously mentioned. Obligations of economic operators The economic operators (manufacturer, importer and distributor) intervening in the supply and distribution chain should take appropriate measures to ensure that they place or make available on the market only construction products which are in compliance with the requirements of the Construction Products Regulation. The main obligations of the manufacturer are:  Make a Declaration of Performance (DoP) for the product and,  Affix the CE marking The manufacturer must also keep technical documentation for ten years, ensure consistent production, ensure the product is identifiable, indicate a contact point on the product and provide instructions and safety information in the appropriate languages. The CPR adds responsibilities to importers and distributors who must assure themselves that the manufacturer has undertaken all that is required. The importer’s or distributor’s name and contact details must appear on the product, labelling or associated documents. Transitional provisions Construction products which have been placed on the market in accordance with Directive 89/106/EEC before 1 July 2013 shall be deemed to comply with the Construction Product Regulation. Manufacturers may draw up a Declaration of Performance on the basis of a certificate or declaration of conformity, which has been issued before 1 July 2013 in accordance with Directive 89/106/EEC. Guidelines for European technical approvals published before 1 July 2013 in accordance with Article 11 of Directive 89/106/EEC may be used as European Assessment Documents. Manufacturers and importers may use European technical approvals issued in accordance with Article 9 of Directive 89/106/EEC before 1 July 2013 as European Technical Assessments throughout the period of validity of those approvals. Legislation Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonized conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L-88 04/04/2011). Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (OJ L-40 11/02/1989)

2.5.1.2.

Technical standards for motor vehicles

(Only required for products intended for the automotive industry)

The placing on the European Union (EU) market of certain categories of motor vehicles must comply with the technical requirements which have been harmonized by EU legislation. EU legislation has harmonized technical requirements for three categories of motor vehicles, namely passenger cars, motorcycles and tractors as well as their trailers, systems, components and separate technical units. A type-approval procedure is established in order to check compliance with the harmonized technical requirements (EC type-approval). Manufacturers who have a “type” approved vehicle in one Member State can market the vehicle in all Member States without further tests. Nevertheless, buses, coaches, commercial vehicles and trucks have not EU harmonised technical requirements, therefore each Member State establishes its own technical approval procedures.

Des entrepreneurs au service des entrepreneurs The EC whole vehicle type-approval system applies to tractors, passenger cars and to motorcycles on a mandatory basis. There are three “framework directives”, which provide for the general rules applicable to the type-approval of motor vehicles, motorcycles and tractors, respectively. Moreover, specific technical requirements for construction and safety (i.e. sound levels, fuel consumption, speed limiters, braking system,…) and testing procedures are laid down in over 90 separate directives. EC Type-approval procedure Applications for type-approval must be submitted by the manufacturer or his authorized representative to the approval authority within a single Member State. These must be accompanied by the manufacturer's dossier and the type-approval certificate for each part and system included in the list of technical requirements for vehicle category. Type-approval shall be granted to all types of vehicle, systems, separate technical units or components if they meet the technical requirements listed for the specific category of vehicle and correspond to the data supplied by the manufacturer. In order to obtain an EC whole vehicle type-approval and be placed on the market, the vehicle must comply with all the relevant directives. The approval authority in each Member State will complete a type-approval certificate and its annexes concerning the results of tests and will send this to the applicant. A reciprocal information system is set up between the type-approval authorities in each Member State. Certain categories of vehicles produced in conformity with the approved type must bear a type-approval mark that consist of the type-approval number, the letter "e" followed by the identifying number or initials of the Member State conducting the type-approval and the vehicle identification number. A certificate of conformity will be drawn up by the manufacturer or his authorized representative for each vehicle, or separate technical unit or component produced in conformity with the approved type. When a vehicle is accompanied by this certificate it may be placed on the market, sold and registered for use throughout the EU. Legislation: Framework Directives  Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (OJ L-263 09/10/2007)  Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles and repealing Council Directive 92/61/EEC (OJ L-124 09/05/2002)  Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (OJ L-171 09/07/2003)

2.5.1.3.

Prohibition of products containing fluorinated greenhouse gases

(Only required for windows containing fluorinated greenhouse gases)

The same as previously mentioned (Section 1.3.1.1).

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2.6. 2.6.1.

Wood and Wood Related Products Specific requirements

Product Description Mattress support Mattresses: of cellular rubber or plastics, whether or not covered Other articles of bedding, furnishings such as pillows, cushions, mattress covers etc.

2.6.1.1.

General product safety

Eco-label for bed mattresses

Restriction on the use of certain chemical substances in textile and leather products

General product safety

Products on the European Union (EU) market for consumers or likely to be used by them, including all products that provide a service and excluding second-hand products that have antique value or that need to be repaired, must comply with the provisions laid down by Directive 2001/95/EC of the European Parliament and of the Council (OJ L-11 15/01/2002) designed to protect consumer health and safety. The General Product Safety Directive (GPSD) establishes the following common provisions concerning particularly:  General safety requirement  Additional manufacturer and distributor obligations  Market surveillance General Safety Requirement Producers are obliged to place only safe products in the market. When the manufacturer is not established in the EU, this obligation applies to his representative in the EU or, in the absence of a representative, to the importer. A safe product is one which poses no threat or only a reduced threat in accordance with the nature of its use and which is acceptable in view of maintaining a high level of protection for the human health and safety, taking into account the following points:  the characteristics of the product, including its composition, packaging, instructions for assembly and for installation and maintenance;  the effect on other products, where it is reasonably foreseeable that it will be used with other products;  the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;  the categories of consumers at risk when using the product, in particular children and the elderly. The General Product Safety Directive establishes the regulatory scheme to determine compliance with the general safety requirement in which the European Standards adopted to define the appropriate safety specifications are considered. Additional manufacturer and distributor obligations In addition to the basic requirement to place only safe products on the market, producers must inform consumers of the risks associated with the products they supply particularly, when such risks are not obvious. They must take measures to be informed of risks posed by the products and take the appropriate measures to prevent such risks (e.g. withdraw products from the market, warning consumers, recall products which have already been supplied to consumers, etc.). The obligations on producers apply to any professional in the supply chain who may affect the safety characteristics of a product. In particular, they are obliged to monitor the safety of products and provide the necessary documents ensuring that the products can be traced. Manufacturers or the distributors must not supply products that they know or should presume to be dangerous. If they discover that a product is dangerous, it must be notified Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs to the competent authorities of the Member States and, if necessary, cooperate with them on the action taken to avoid the risks for consumers. Market surveillance Nominated authorities in the Member States are in charge of checking that the products meet the applicable safety requirements. They may take appropriate measures to impose marketing restrictions, require product withdrawal from the market or recall products when there is evidence that there is any danger. The Directive also sets up a system for Rapid exchange of information among Member States authorities and the Commission on measures adopted to prevent, restrict or impose specific conditions on the marketing or use of products posing serious risks.

2.6.1.2.

Eco-label for bed mattresses

The general procedure applied here (“Flower logo”). Product scope According to Commission Decision 2014/391/EU (OJ L-184 25/06/2014) the product group ‘bed mattresses’ comprises products consisting of a cloth cover that is filled with materials and that can be placed on an existing supporting bed structure or designed for free standing in order to provide a surface to sleep or rest upon for indoor use. The product group does not include wooden and upholstered bed bases, inflatable mattresses and water mattresses. Requirements In order to be awarded the Community Eco-label, bed mattresses must comply with the criteria set out in the Annex to Commission Decision 2014/391/EU referring to:  Latex foam  Polyurethane (PUR) foam  Wire and springs  Coconut fibres  Wooden material  Textiles (fabrics and fibres used as mattress cover and/or filling materials)  Glues and adhesives  Flame retardants  Biocides  Plasticizers  Excluded or limited substances and mixtures  Emission of specified volatile organic compounds (SVOCs, VOCs, VVOCs) from the mattress  Technical performance  Design for disassembly and recovery of materials  Information appearing on the EU Eco-label  Additional information to consumers The end of the period of validity of the criteria for bed mattresses will be 23 June 2018. Legislation  Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Eco-label (OJ L-27 30/01/2010)  Commission Decision 2014/391/EU of 23 June 2014 establishing the ecological criteria for the award of the Community Eco-label for bed mattresses (OJ L-184 25/06/2014)

2.6.1.3. Restriction on the use of certain chemical substances in textile and leather products (Only required for those made up of textile and leather products)

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The placing in the EU market of textile and leather articles containing certain chemical substances, group of substances or mixtures are prohibited or severely restricted, in order to protect human health and environment, according to provisions listed on Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH Regulation) (OJ L-396 30/12/2006) According to this Regulation, the main chemical substances, group of substances or mixtures which are not allowed in textile and leather articles are:  Tris (2,3 dibromopropyl) phosphate in textile articles intended to come into contact with the skin.  Tris (aziridinyl) phosphinoxide in textile articles intended to come into contact with the skin.  Polybrominated biphenyls (PBB) in textile articles intended to come into contact with the skin.  Mercury compounds in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture.  Dioctyltin (DOT) compounds in textile articles, footwear or part of footwear intended to come into contact with the skin.  Nickel in articles intended to come into direct and prolonged contact with the skin, such as rivets buttons, lighteners, rivets, zippers and metal marks, when these are used in garments.  Azodyes which may release one or more of the aromatic amines listed in Appendix 8, in textile and leather articles which may come into direct and prolonged contact with the skin or oral cavity.  Nonylphenol and nonylphenol ethoxylates in textile and leather processing. All manufactures and importers of chemical substances must identify and manage the risks linked to the substances they manufacture and market in the EU. The European Chemicals Agency (ECHA) manages and coordinates the registration, evaluation, authorization and restriction processes of chemical substances to ensure consistency in management of chemicals across the EU. Legislation: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L-396 30/12/2006)

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3. Taxes and import tariffs The EU is a Customs Union, its 28 member countries form a single territory for customs purposes. This means that:  no customs duties are paid on goods moving between EU countries  all apply a common customs tariff for goods imported from outside the EU  goods that have been legally imported can circulate throughout the EU with no further customs checks. Thus, under the provisions of Article 294-2.1° and 2° of the French General Tax Code, the departments overseas are exporting territories with regard to France and the Member States of the Union European. To facilitate and encourage trade with third countries preferential trade agreements were implemented. This can significantly improve market access (eliminate or reduce tariffs and facilitate procedures). Regarding Trinidad and Tobago Economic Partnership Agreements (EPAs) are:  trade and development arrangements between the EU and Caribbean and Pacific (ACP) countries:  designed to facilitate the ACPs' integration into the world economy through gradual trade liberalisation and improved trade-related cooperation  tailored to suit specific regional set within the framework of the EU-ACP Partnership Agreement (Cotonou Agreement) Under the EPAs, EU markets are immediately and fully opened. Goods listed in this study, exported to DFA have to be charged without VAT by the provider. Upon arrival, they must be submitted, with customs clearance and duties and taxes in force (“octroi de mer”, VAT, import duties).

3.1. 3.1.1.

Taxes and duties The “Octroi de mer”

All products whether imported or produced in French Overseas Departments are generally subjected to these dock taxes. The rates are fixed by resolution of the Regional Council which alone is the competent Authority to decide the level of taxation. It should be noted that the O.M. is locally set and not at the EU level. It is specific to the FCORs to cover costs related to Government Administration in the territory. An important principle in the application of the tax is that there should be the same taxation regime for similar or identical products that are imported, regardless of their origin. Differences in taxation between local production and imports should be similarly determined based on handicaps that affect local production. CARICOM and EU products (including France) are placed under the same taxation regime. The law provides for the coexistence of a general scheme and 3 annexes lists of products that have a specific taxation. These lists are specific to each region and are classified according to three letters, A, B and C, listing the products for which the tax differential may not exceed 10, 20 and 30 percentage points. Martinique has 11 dock dues rates (from 0% to 50 %), supplemented by three regional rates (0%, 1,5% and 2,5 %) Guadeloupe: Dock dues is 7 percent on average Rates are detailed in the table below:

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Guadeloupe Martinique Region Region O.M. O.M. al O.M. al O.M. FOOD AND BEVERAGES 7% 2.5% 7% 2.5% 0% 1,5%

Product Description

Curry Chocolate confectionery Other, spaghetti, macaroni, 7% 2.5% 0% 2,5% noodles, shells Other [Prepared corn products 7% 2.5% incl cereals] Sweet biscuits 7% 2.5% 0% 2,5% Wafers & waffles 7% 2.5% Other [Roti skins] 7% 2.5% Prepared corn products 7% 2.5% 0% 1,5% Prepared potato & multigrain 7% 2.5% 0% 1,5% products Other [Fried & Pepper - Chick 7% 2.5% Peas or Split Peas] Other orange juices 7% 2.5% 0% 2,5% Other mixtures, fruit juices 7% 2.5% 0% 2,5% Tomato ketchup 7% 2.5% 0% 1,5% Other tomato sauces [BBQ 7% 2.5% 0% 1,5% Sauce] Pepper sauce 7% 2.5% 0% 1,5% Mayonnaise 7% 2.5% 0% 1,5% Amchar, kuchela and similar 7% 2.5% 0% 1,5% preparations Other sauces and preparations [incl Green liquid seasoning; 7% 2.5% 0% 1,5% powdered seasoning] Aerated waters 7% 2.5% 0% 2.5% Aerated beverages 7% 2.5% 0% 2.5% Other drinks 7% 2.5% 0% 2.5% Chemicals & Non-Metallic Minerals Dish washing liquids 7% 2.5% 0% 1,5% Liquid bleaches for retail 7% 2.5% 0% 1,5% Liquid detergents 7% 2.5% 0% 1,5% Other detergents 7% 2.5% 0% 1,5% Preparations for the treatment of textile materials or other materials 7% 2.5% 0% 1,5% [Fabric softener] Disinfectants 7% 2.5% 0% 1,5% Paper, Printing, Packaging and Publishing Plastic bottles [packaging 7% 2.5% 7% 2.5% material] Toilet paper 7% 2.5% 0% 1,5% Articles of Base Metal [Construction Materials] Aluzinc roofing sheets, floor 7% 2.5% 7% 2.5% decking Aluminium profiles [to produce doors, windows, handrails, solar 7% 2.5% 7% 2.5% panels, angles, flats etc] Aluminium louvres

windows,

doors,

2.5%

French Guiana Region O.M. al O.M. 15% 7%

2.5% 2.5%

2.5%

7% 7% 7% 7%

2.5% 2.5% 2.5% 2.5%

2.5%

7% 7% 7%

2.5% 2.5% 2.5%

2.5%

7% 7%

2.5% 2.5%

15%

2.5%

20%

2.5%

7.5% 17.5% 17.5%

2.5% 2.5% 2.5%

15% 15% 15% 15%

2.5% 2.5% 2.5% 2.5%

15%

2.5%

15%

2.5%

15%

2.5%

15%

2.5%

7.5%

2.5%

15%

2.5%

15%

2.5%

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Wood and Wood Related Products Mattress support Mattresses: of cellular rubber or plastics, whether or not covered Other articles of bedding, furnishings such as pillows, cushions, mattress covers etc.

3.1.2.

2.5%

17.5%

2.5%

17.5%

2.5%

17.5%

2.5%

The Value Added Tax (VAT)

A percentage of Value Added Tax (VAT) revenue, calculated on a unified basis, is allocated to finance the EU budget. VAT is imposed on the added value at each stage of the production chain of any product or service, levied on final consumption and collected fractionally. The structure of VAT is harmonised within the EU. The basic legislation is the Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax. The main activities subject to VAT are: 1. supply of goods for commercial purposes, within the territory of a EU country, made by a taxable person. 2. supply of services: VAT is chargeable in the EU country where the recipient of the service is established. 3. intra-Community transactions 4. Imports: VAT is levied on the importation of goods and usually charged when customs clearance procedures take place in order to be released for circulation. Taxable transactions are subject to the rates and regulations approved by the EU country to which the goods or services are supplied. Each EU country can fix rates according to the following limits:  the standard rate  EU countries may also apply either one or two reduced rates, applied to very specific supplies of goods.  the Directive allows the application of a reduced rate (the "parking rate") for some goods or services.  it also allows certain EU countries to maintain of reduced rates (super reduced rates) In French Overseas Departments, Regional Councils can determined that certain transactions relating to categories of local products will be totally or partially exempted by applying a zero or reduced rate. This tax is 2.5% plus an 8.5% VAT. The VAT is reduced to 2.1% on food and medical products. All imports, except cigarettes, have an “overseas tax” of between 5 % and 25% of duty value.

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3.2. 3.2.1.

Import tariffs Import Licensing

As part of the European Union, imports from third countries (non-European Union countries) are subjected to regulation. They are covered by the EU commitments under the Economic Partnership Agreement (EPA) applying duty-free-quota-free market access to almost all products from CARIFORUM countries. A limited number of products considered to be sensitive may require a specific import license. These non-liberalized goods need a specific import licenses, which is issued by the Office of the Prefect of Martinique. Such licenses are usually valid for six months from the date of issuance and can be extended for an additional 30 days if a justifiable reason is provided.

3.2.2.

Foreign Exchange Controls

Martinique does not place restrictions on the repatriation of profits, service fees, interest or royalties. However, an approved bank must be used and the investment must be one which was authorized by the government officials. Bank transfers are generally used for the transfer of money overseas or into Martinique and through approved banking intermediaries by bank transfers.

3.2.3.

Trade barriers

Hiding behind high consumption prices is the true issue of French overseas territories, as to say a lack of competition. Standing next to the natural trade barriers, distance to his mainland or standards and regulations applying, are monopolistic imbalances mainly in mass market retail, telecommunications and fuel. From the point of view of CARICOM countries, the main trade barriers are: -

EU Regulations and standards Transport availability and cost Duties Lack of representations in the territories Language Licencing requirements and bureaucracy Limited notion of the market Differences in trade legislation Domination of large companies on the export market Difficult access to information

3.2.4.

Custom duties

Import tariffs are the most common, and involve a tax being assessed on products coming in from another country. The EU's Binding Tariff Information (BTI) system can help you identify the right tariff classification for the goods you intend to export. To obtain Binding Tariff Information, you must apply to the customs authorities of the EU country you wish to export to, using the BTI application form. The BTI is valid throughout the EU, regardless of which EU country issued it. A BTI is generally valid for 6 years. Having a BTI gives you legal certainty about the tariff classification of the product you wish to export. This is the basis for determining customs duties and whether or not you need an import certificate. Legal basis: Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs  



Article 12 of the Customs Code sets out the specific provisions for Binding Tariff Information. Articles 6-11 set out the general provisions concerning decisions and information obtained from customs authorities and have to be taken into account (Council Regulation (EEC) N° 2913/92 of 12 October 1992 establishing the Community Customs Code); The above mentioned provisions are further clarified by Articles 5 to 14 of the Implementing Provisions of the Community Customs Code (Commission Regulation (EEC) N° 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) N° 2913/92 establishing the Community Customs Code).

For products covered by this study the following table will detail:  Duty applicable to a product for third countries in general (ERGA OMNES) Erga omnes is the legal term for obligations or rights towards all. However developing countries have advantageous conditions to enter the EU market. You may not have to pay the full tariff –or indeed any at all-. Hence, next to the "erga omnes" tariff, you may find the preferential agreement that your country has and the reduced tariff it implies. 

Preferential duty applicable to a particular country – depending on the trade agreement or scheme in place.

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Product Description Curry

Guadeloupe/Martinique

French Guiana

0% 8.3%+ Additional rights on 8.30 % + EA(1) MAX 18.70 % sugar+ agricultural +ADSZ(1) elements:18.7% maximum

Chocolate confectionery

Other, spaghetti, 7.7% + 24.6€ / 100Kg macaroni, noodles, shells Other [Prepared corn 8.3% + 46€ / 100Kg products incl cereals]

24.6 €/100Kg 6.4% 9.7 €/100Kg 6.4%

Sweet biscuits

9% + EA(1) MAX 24.2% + ADSZ

Wafers & waffles

9% + EA(1) MAX ADFM(1)

20.7% +

3.8% + 15.90€ / 100Kg Non preferential tariff quota: 40% 9% + EA(1) MAX 20.7% + ADFM(1) Non preferential tariff quota: 40%

Other [Roti skins]

Prepared corn products Prepared potato & multigrain products Other [Fried & Pepper Chick Peas or Split Peas] Other orange juices Other mixtures, fruit juices Tomato ketchup Other tomato sauces [BBQ Sauce] Pepper sauce Mayonnaise Amchar, kuchela and similar preparations Other sauces and preparations [incl Green liquid seasoning; powdered seasoning] Aerated waters Aerated beverages Other drinks Dish washing liquids Liquid bleaches for retail Liquid detergents Other detergents Preparations for the treatment of textile materials or other materials [Fabric softener] Disinfectants Plastic bottles [packaging material] Toilet paper Aluzinc roofing sheets, floor decking

+Additional rights on sugar+agricultural elements 24.2% maximum Additional rights on flower and agricultural elements: 20.7% maximum 15.9 euro/100Kg 3.8% Agricultural elements 9% Maximum 20.7% additional rights on flower

8.8% + EA(1)

14.1%

19.2%

15.2% + 20.60€ / 100Kg 10.5% + 12.90€ / 100Kg 10.2%

15.2%+20.6.6 €/100Kg 33.6% 10.2%

10.2%

0% 0%

7.7% 7.7%

7.7%

0% 9.6% 6.4% + 13.70€ / 100Kg 4% 4% 4% 4%

0% 9.6% 9.6% 4% 4% 4% 4%

4.6%

6.5%

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Aluminium profiles [to produce doors, windows, handrails, solar panels, angles, flats etc] Aluminium windows, doors, louvres Mattress support Mattresses: of cellular rubber or plastics, whether or not covered Other articles of bedding, furnishings such as pillows, cushions, mattress covers etc.

7.5%

3.7%

Sources: Taxation and Customs Union databases: TARIC consultation Caption:  EA - élément agricole: stands for "agricultural component", which is a type of additional duty.  ADFM - droit additionnel sur la farine : stands for "additional duty on flour contents".  ADSZ - droit additionnel sur le sucre : "additional duty on sugar contents"  The digit between round brackets: (1), is the reduction indicator, explained below. Example (to adapt to the case at hand) : On June 01, 2006, for goods code 1905 90 45 "Biscuits", the duties are the following: - Third country duty: 9 % + EA(1) MAX 20.7 % +ADFM(1) - Tariff preference for Israel: 0 % + EA(1) MAX 20.7 % +ADFM(1) - Preferential quota for Israel: 0 % + EAR(1) MAX 20.7 % +ADFMR(1) The third country duty rate should be read as such: (9% + EA), limited to a maximum of (20.7% + ADFM) To compute the complete rate of duty, it is necessary to determine the agricultural component and the additional duty on flour contents. To this end, the composition of the product in Milk fat, Milk proteins Starch/Glucose Sucrose/Invert sugar/Isoglucose must be known by the declarant. The values of EA and ADFM are determined by a given ingredient composition. This composition of ingredients matches a 4 digit additional code that must be declared at customs. TARIC Consultation : http://ec.europa.eu/taxation_customs/dds2/taric/taric_consultation.jsp?Lang=en To determine the additional code to declare, click on the "Additional duties" button in the "duty rates" page. This opens a window where the composition of the goods must be entered (percentage of milk fat, milk proteins, starch...) with dropdown lists. Once the composition is entered, click on the equal sign (=) to display the extra duties applicable and the additional code to declare. Only the last 3 digits of the additional code are displayed/entered since the additional code always starts with "7". If the additional code is already known, the last 3 digits can be entered in the field labelled "or enter your additional code" For the example, "210" was entered in that field. The additional code to declare in customs is then 7210. The additional duties displayed are always in Euros per 100 Kg. The first information is: EA, ADFM, ADSZ. These are the full (i.e. non reduced) additional Reference: CAYRIBE - ExporTT – Market Survey French Caribbean - Regulation_01_B CAYRIBE SARL Société à responsabilité limitée au capital de 60.000 Euros R.C.S. Pointe-à-Pitre 531 976 215 Siège social: 127, rue Nobel – ZI Jarry – 97122 Baie-Mahault CAYRIBE ® - Reproduction interdite - V1.1

Des entrepreneurs au service des entrepreneurs duties. The values displayed there must be replaced in the expression above. In the example, EA=46.37 eur/100 kg, ADSZ=0 Eur/100kg, ADFM=8.88 Eur/100 kg And the third country duty is then: (9 + 46.37 eur/100 kg) limited to a maximum of (20.7% + 8.88 eur/100 kg)

Note : About download TARIC data. TARIC data is available for FREE download on the TARIC data download site, at the following address: http://circa.europa.eu/Public/irc/taxud/taric_data/home Access to the data is public and does not require any subscription to the TARIC data download site. However it is possible to become a member. The membership enables you to receive email notifications when new data is made available on the site. If you wish to become a member of the site, you need to create a username first. To this end, please go to the following address: http://circa.europa.eu/Public/irc/taxud/home/main click on the "sign up" button, and follow the given instructions. Once you have received your username and password, you can apply for membership to the TARIC data download site. Once your application is accepted by the manager of the site, you will receive an email confirming it. Being a member does not give you access to more data than anonymous access. The TARIC data is made available in zipped Excel files.

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4. ANNEXES Templates 1. 2. 3. 4. 5. 6. 7.

Declaration by the exporter Single Administrative Document Commercial invoice Certificate of origin Custom value declaration_dv1 Movement certificate EUR.1 Packing List

Labelling foodstuffs (ANNXES) 8. List of ingredients 9. Name of the food 10. Date of minimum durability 11. Alcool stenght Example 12. How to export juice to the EU

The “Octroi de mer” 13. CERFA form n°12449-01 Import Tariff 14. General information General Information BTI 15. Additional informations for France

Imported products packaging samples 16. Packaging sample for Ginger candy from China 17. Packaging sample for instant noodles from China