This Regulation lays down provisions for the application of Council Regulation (EC) No 3036/94 establishing economic outward processing arrangements applicable to certain textile and clothing products reimported into the Community after working or processing in certain third countries, hereinafter referred to as the 'basic Regulation`, especially with respect to the issue and control of prior authorizations.

identification of the strain(s) in accordance with the authorization granted, the file number of the strain(s), the number of colony-forming units (CFU per gram), the EC registration number of the additive, the name or business name and the address or registered place of business of the person responsible for the particulars on the label, the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars on the label, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use and, where applicable, safety recommendations as provided for in the authorization for the additive, the net weight and, in the case of liquid additives, either the net volume or the net weight, where appropriate an indication of special significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive.

The particulars and documents accompanying an application for marketing authorization, pursuant to Article 8(3)(h) and (i) and Article 10, paragraph 1 of this Directive, shall include particulars relating to the product control tests that may be carried out at an intermediate stage of the manufacturing process, with a view to ensuring the consistency of the technical characteristics and the production process.

For the purposes of Article 3 (5) (3) of the basic Regulation the value of the Community production is calculated on the basis of the normal ex factory price, exclusive of VAT, of products, shown in Annex II of the basic Regulation that have been manufactured in the Community in the previous year, whether in the applicant's factory or on his account by another manufacturer, as much as the latter business does not also introduce a request for prior authorization for the same Community production for the same period.

Within 90 days of the receipt of the assessment report, the Member State concerned shall either recognize the decision of the first Member State and the summary of the product characteristics as approved by it or, if it considers that there are grounds for supposing that the authorization of the medicinal product concerned may present a risk to public health, it shall apply the procedures set out in Articles 29 to 34.

The particulars and documents accompanying an application for marketing authorization pursuant to Articles 12 and 13(1) shall be presented in accordance with the requirements set out in this Annex and taking account of the guidance contained in the "Notice to applicants for marketing authorizations for veterinary medicinal products in the Member States of the European Community", published by the Commission in The rules governing medicinal products in the European Community, volume V:

the specific name of the active component(s) according to its (their) enzymatic activity(ies) in accordance with the authorization given, the identification number according to the International Union of Biochemistry, the activity units (activity units per g or activity units per ml), the additive's EC registration number, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended dose, in the form of a range if appropriate, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive;

Notwithstanding the provisions of Article 1, for a transitional period ending not later than 31 December 1995 and provided that the applicant, at the time of his application has not requested the issue of a Community import licence conforms to the specimen set out in Appendix 1, the competent authorities of the Member States shall be authorized to use their own national forms to issue the import authorizations and any extracts thereof.

whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation (9), nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment (10);

Member States, on examination of an application for authorization, shall inform the Commission of instances where they consider an active substance to be listed in Annex I, which has been produced by a person or manufacturing process other than those specified in the dossier on the basis of which the active substance was first included in Annex I. They shall transmit to it all data regarding the identify and impurities of the active substance.

The particulars and documents accompanying an application for marketing authorization pursuant to Articles 12 and 13(1) shall be presented in accordance with the requirements set out in this Annex and taking account of the guidance contained in the "Notice to applicants for marketing authorizations for veterinary medicinal products in the Member States of the European Community", published by the Commission in The rules governing medicinal products in the European Community, volume V: Veterinary Medicinal Products.

The Commission shall inform the other Member States accordingly. 3. To ensure correct application of the provisions governing the procedure, the customs authorities may require the holder of the authorization, in order to facilitate checks, to keep or have kept for him stock records which indicate the quantities of import goods entered for the procedure and of processed products obtained, and all particulars needed for the monitoring of the operations and the correct calculation of any import duties which may be payable.

When the application concerns a category of products whose release into free circulation in the Community is subject to the measures provided for in Article 1 (3) of the basic Regulation, the prior authorization is issued by the competent authorities only when the Commission has confirmed the availability of the quantity notified by the authorities managing the request in accordance with the procedures laid down in Annex VII of Regulation (EEC) No 3030/93.

(units of activity per gram or units of activity per millilitre), the EC registration number of the additive, the name or business name and the address or registered place of business of the person responsible for the particulars on the label, the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars on the label, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended dose, in the form of a range if appropriate, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, safety recommendations as provided for in the authorization for the additive, the net weight and, in the case of liquid additives, either the net volume or the net weight, where appropriate indication of special significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization for the additive;

Without prejudice to Article 4 of Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (14), and laying down additional provisions for immunological veterinary medicinal products, a marketing authorization which has been granted in accordance with the procedure laid down in this Regulation shall apply throughout the Community.

-details of authorizations laying down emission standards for discharges of mercury, -the results of information collected or inventories drawn up concerning mercury discharged into the maritime area, and into watercourses that affect the maritime area, referred to in Article 1, paragraph 1, -information laid down in Annex IV, paragraph 2 for those Contracting Parties applying the quality objectives, -the results of the monitoring of the aquatic environment carried out in accordance with Article 3.

Whereas rules for harmonization in the field of additives should not affect the application of provisions of Member States existing on 1 January 1992, which prohibit the use of certain additives in certain specific foodstuffs which are considered as traditional and are produced on their territory, provided that those provisions do not cover a whole series of foodstuffs including foodstuffs which do not come under this Directive but regarding which Community provisions provide for authorization of additives;

Whereas pursuant to the provisions of Council Directive 93/114/EC (4) it is necessary to include in the Community procedure for the authorization of additives the requirements of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (5), as amended by Commission Directive 94/15/EC (6) for a specific environmental-risk evaluation, in order that they may be applicable to all additives containing or consisting of genetically modified organisms;

The provisions of Directive 84/360/EEC, the provisions of Articles 3, 5, 6 (3) and 7 (2) of Directive 76/464/EEC and the relevant provisions concerning authorization systems in the Directives listed in Annex II shall apply, without prejudice to the exceptions provided for in Directive 88/609/EEC, to existing installations in respect of activities listed in Annex I until the measures required pursuant to Article 5 of this Directive have been taken by the competent authorities.

Whereas, on the adoption of Council Directive 94/5/EC of 14 February 1994 supplementing the common system of value added tax and amending Directive 77/388/EEC - Special arrangements applicable to second-hand goods, works of art, collectors' items and antiques (6), the Commission and the Member States accepted the obligation to review the conditions for the authorization and the functioning of temporary importation procedures and agreed to allow, for these goods, a period of 24 months to remain under temporary importation;

Where the compensating products obtained from inward processing operations under the drawback system are consigned to another customs office under the external Community transit procedure, which may constitute justification for a request for repayment, and are the subject of a new inward processing application, the duly empowered customs authorities responsible for issuing the new authorization shall use the Information Sheet INF 1 referred to in Article 611 to determine the amount of any import duties to be levied or the amount of the customs debt liable to be incurred.'

Where a Member State makes use of the option provided for in Article 59 of Regulation (EC) No 1782/2003, and it decides to apply Article 7 of this Regulation, for the purpose of the allocation of payment entitlements in accordance with that Article 7, the number of payment entitlements to which an authorization as referred to in Article 60 of Regulation (EC) No 1782/2003 is linked shall be equal to the initial number of payment entitlements with the authorisation and, where the case may be, no higher than the number of payment entitlements allocated.

Notwithstanding the provisions of Article 31, for a transitional period ending not later than 31 December 1995 and provided that the applicant, at the time of this application has not requested the issue of a Community import licence conforming to the specimen set out in Appendix 1, the competent authorities of the Member States shall be authorized to use their own national forms to issue the import authorizations or surveillance documents and any extracts thereof, instead of the forms referred to in Article 31.

Where a T2L document is to be made out in respect of a consignment comprising two or more kinds of goods, the particulars relating to those goods may be entered on one or more loading lists within the meaning of Articles 341 (2) to 344 (2) rather than in boxes 31 'Packages and description of goods', 32 'Item No', 35 'Gross mass (kg)', and, where applicable, 33 'Commodity code', 38 'Net mass (kg)' and 44 'Additional information/documents produced, certificates and authorizations' of the form used for the T2L document.

Whereas to facilitate the introduction of such a Community import licence in all Member States, it seems appropriate to authorize the competent authorities of the Member States, during a transitional period which shall end no later than 31 December 1995, to continue to issue the national forms that were in use before the date of entry into force of this Regulation for issuing import authorizations and surveillance documents, unless the applicant, at the time of this application, has requested the issue of a Community import licence;

Member States shall inform the Commission of cases where they have required repetition of a test and of cases where they have refused to authorize a plant protection product already authorized in another Member State, in respect of which the applicant had claimed that the agricultural, plant health and environmental (including climatic) conditions relevant to use of the product in the regions concerned in the Member State where the test was carried out or for which authorization was granted were comparable to those in their own territory.

In the case of a serious breach or repeated minor breaches of road safety regulations, in particular with regard to the rules applicable to vehicles, driving and rest periods for drivers and the provision without authorization of parallel or temporary services, as referred to in Article 2 (1.3), the competent authorities of the Member State of establishment of the carrier who committed the breach may inter alia withdraw the Community licence or make temporary and/or partial withdrawals of the certified true copies of the Community licence.

Where the compensating products obtained from inward processing operations under the drawback system are consigned to another supervising office in the same or another Member State under the external Community transit procedure, which may constitute justification for a request for repayment, and are the subject of a new inward processing application, the duly empowered customs authorities responsible for issuing the new authorization, either with the suspension system or with the drawback system, shall use the INF 1 sheet referred to in Article 611 to determine the amount of any import duties to be levied or the amount of the customs debt liable to be incurred.

Declarations of entry for a customs procedure with economic impact other than outward processing or customs warehousing which the customs office of entry for the procedure may accept at the declarant's request without their containing some of the particulars referred to in Annex 37 or without their being accompanied by certain documents referred to in Article 220 must contain at least the particulars referred to in Boxes 14, 21, 31, 37, 40 and 54 of the single administrative document and, in Box 44, a reference to the authorization, or a reference to the application where the second subparagraph of Article 556 (1) applies.'

Where the purpose of the processing operation is the repair of temporary export goods and such repair is carried out in return for payment, the partial relief from import duties provided for in Article 145 shall be granted by establishing the amount of the duties applicable on the basis of the taxation elements pertaining to the compensating products on the date of acceptance of the declaration of release for free circulation of those products and taking into account as the customs value an amount equal to the repair costs, provided that those costs represent the only consideration provided by the holder of the authorization and are not influenced by any links between that holder and the operator.

products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves as defined in point 6; 'harmful organisms' pests of plants or plant products belonging to the animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens; 'animals' animals belonging to species normally fed and kept or consumed by man; 'placing on the market' any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the Community or disposal. Importation of a plant protection product into the territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive; 'authorization of a plant protection product' administrative act by which the competent authority of a Member State authorizes, following an application submitted by an applicant, the placing on the market of a plant protection product in its territory or in a part thereof; 'environment' water, air, land, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms; 'integrated control' the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the strict minimum necessary to maintain the pest population at levels below those causing economically unacceptable damage or loss. General provisions

verification of the price and where applicable, the currency exchange rate, on the basis of the contract between the exporter and the importer, the pro forma invoice and, where applicable, the application for import authorization.