whereas these resources are to include those accruing from value added tax and obtained by applying a common rate of tax on a basis of assessment determined in a uniform manner according to Community rules;

In accordance with Article 274 of the Treaty, the Commission shall decide to grant financial aid under this Regulation according to its assessment of the application in accordance with the selection criteria.

emissions (including leachate) from the landfill, taking into account the limits for those specific parameters in this section, will present no additional risk to the environment according to a risk assessment.

Conversely, where the assessment leads to the conclusion that the proposed commitments appear not to be sufficient to resolve the competition concerns raised by the concentration, the parties will be informed accordingly.

Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Bondronat.

If a Member State wishes to supplement assessment of compliance of a third country by evaluating certain maritime training institutes, it shall proceed according to the provisions of section A-I/6 of the STCW Code."

Following the assessment referred to in Article 3, measures shall be determined in accordance with Annex V, after fixing the physical containment level required for the biological agents according to the degree of risk.

In general, plant-protection products are only authorised for those specified uses, which are acceptable on the basis of an assessment according to the uniform principles laid down in Annex VI of this Directive.

Among the 61 patients treated at an initial dose of 300 mg/ m2/ day, the overall response rate, according to a global assessment by the physician, was 51 % (31/ 61) with a clinical complete response rate of 3 %.

According to the SCAN opinion on Bacillus cereus var. toyoi (NCIMB 40 112) adopted on 21 March 2001, the assessment of the dossiers submitted shows that the product may be considered safe as regard toxin production.

Before placing pressure equipment on the market, the manufacturer shall subject each item of equipment to one of the conformity assessment procedures described in Annex III, according to the conditions given in this Article.

the PEC/PNEC is above 1 unless it is clearly established in the risk assessment that under field conditions no unacceptable effects occur after use of the biocidal product according to the proposed conditions of use, or

the unit trust's/common fund's or the investment company's investment policy and a brief assessment of the fund's risk profile (including, if applicable, information according to Article 24a and by investment compartment),

As can be seen from these decisions, Art. 87(3)(d) allows aid to be granted to film production according to the specific circumstances in each Member State, and notably for the flexibility in the assessment of aid to difficult and low budget films.

Among 135 patients undergoing retroperitoneal and intra-abdominal surgery (67 patients treated with EVICEL and 68 controls), no adverse events were considered to be causally related to the study treatment according to the investigator assessments.

According to the assessment referred to in paragraphs 2 and 3, the Commission shall adopt, having regard to the available sources of funding under the relevant Community instruments and according to the procedure set out in Article 21, a prioritized action framework of measures involving co-financing to be taken when the site has been designated under Article 4 (4).

In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).

According to Article 5(2) of this Directive, the user is required to carry out an assessment of the contained uses of genetically modified micro-organisms (GMMs), using as a minimum the principles set out in Annex III supplemented by guidance notes.

As far as applicable, the specific safety precautions should reflect the results of such assessments according to the uniform principles and should be applied in particular in those cases where risk-mitigation measures are necessary to prevent unacceptable effects.

The PEC in soil were calculated for intensively reared animals and pasture animals, according to the CVMP Guideline on Environmental Impact Assessment for Veterinary medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005-corr).

the PEC/PNEC is above 1 unless it is clearly established in the risk assessment that under field conditions the viability of aquatic organisms including marine and estuarine organisms is not threatened by the biocidal product according to the proposed conditions of use, or

Within 90 days after receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, the summary of product characteristics, the labelling and the package leaflet and inform the reference Member State accordingly.

Within 90 days of receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the reference Member State accordingly.

either, in accordance with the introductory provisions of Annexes II and III of the Directive, the scientific or technical reasons demonstrating that the information is not necessary for the assessment of the active substance according to the criteria referred to in Article 5 of the Directive,

unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species (predators) occurs - directly or indirectly - after use of the plant protection product according to the proposed conditions of use.

According to Article 4 of Regulation (EC) No 1980/2000, specific eco-label criteria should be established according to product groups, and a review of the eco-label criteria as well as of the assessment and verification requirements related to the criteria should take place in due time before the end of the period of validity of the criteria specified for each product group, resulting in a proposal for prolongation, withdrawal or revision.

Risk assessment - The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences;

the bioconcentration factor (BCF) related to fat tissues in non-target vertebrates is above 1 unless it is clearly established in the risk assessment that under field conditions no unacceptable effects occur, either directly or indirectly, after use of the product according to the proposed conditions of use.

Unless the Governing Council of the ECB decides to modify the calendar according to paragraph 2, the maintenance period shall start on the settlement day of the main refinancing operation following the meeting of the Governing Council, at which the monthly assessment of the monetary policy stance is pre-scheduled.

the bioconcentration factor (BCF, related to fat tissue) is greater than 1, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur - directly or indirectly - after use of the plant protection product according to the proposed conditions of use.

The Scientific Committee on Food concluded that because of the wide physical and chemical differences in smoke flavourings used for flavouring food, it is not possible to design a common approach to their safety assessment and, accordingly, toxicological evaluation should focus on the safety of individual smoke condensates.

Whereas the assessment, according to the general criteria chosen, of the unfair character of terms, in particular in sale or supply activities of a public nature providing collective services which take account of solidarity among users, must be supplemented by a means of making an overall evaluation of the different interests involved;

Should the Commission indicate its agreement with a recommendation that the ecological criteria and related assessment and compliance verification requirements should be revised, the EUEB shall proceed accordingly, taking into account the procedure and requirements detailed in the section entitled "Mandate to develop or revise criteria".

The safety of the veterinary medicinal product has not been established during pregnancy and lactation, nor in breeding animals, although in laboratory animal studies no indications of relevant effects on reproduction or fetal development were observed. Use only accordingly to the benefit/ risk assessment by the responsible veterinarian.

The data considered relevant and therefore chosen as the basis for the risk assessment by the rapporteur on each effect or property and each exposure group listed in Annexes I A and II A and for each environ mental property and environmental sphere according to Annex III shall be submitted to the Commission of the European Communities using an appropriate computer program.

According to Article 3(4) of the Directive, the conformity of secure signature-creation-devices with the requirements laid down in Annex III shall be determined by appropriate public or private bodies designated by Member States and the Commission shall establish criteria for Member States to determine whether a body should be designated for performing such conformity assessments.

Where the provisions of paragraph 1 have been complied with, and the results of the inspection and verification are satisfactory, the Member State in question may provide endorsement of a claim by a laboratory that it and the tests that it carries out comply with GLP, using the formula "Assessment of conformity with GLP according to Directive 2004/9/EC on... (date)".

If, as a result of the feasibility assessment referred to in paragraph 1, it is considered necessary to adapt the provisions of Annex I, section 3.2, to include a combination of passive and active measures which afford at least the same level of protection as the existing provisions of Annex I, section 3.2, the Commission shall submit a proposal to the European Parliament and the Council to amend this Directive accordingly.

Without prejudice to Article 8(2), the prospectus shall contain all information which, according to the particular nature of the issuer and of the securities offered to the public or admitted to trading on a regulated market, is necessary to enable investors to make an informed assessment of the assets and liabilities, financial position, profit and losses, and prospects of the issuer and of any guarantor, and of the rights attaching to such securities.

In the case of applications for ETAs according to Article 8.2 b of the Directive, the Commission of the EC will confirm on the basis of the EOTA assessment and of the relevant information, whether a product of a family covered by harmonized standards or recognized national standards differs significantly from them and therefore if a European technical approval can be granted.

The listing particulars shall contain the information which, according to the particular nature of the issuer and of the securities for the admission of which application is being made, is necessary to enable investors and their investment advisers to make an informed assessment of the assets and liabilities, financial position, profits and losses, and prospects of the issuer and of the rights attaching to such securities.

Where a public offer relates to transferable securities other than those referred to in Articles 7 and 8, the prospectus must contain the information which, according to the particular nature of the issuer and of the transferable securities offered to the public, is necessary to enable investors to make an informed assessment of the assets and liabilities, financial position, profits and losses and prospects of the issuer and of the rights attaching to the transferable securities.

by epidemiological studies, by scientifically valid case studies as specified by Annex VI to Directive 67/548/EEC or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases, that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph 1, then the preparation shall be classified according to its effects on man,

If, on the basis of an assessment of environmental risks taking into account, in particular, Directive 80/68/EEC(1), the competent authority has decided, in accordance with Section 2 ("Water control and leachate management"), that collection and treatment of leachate is not necessary or it has been established that the landfill poses no potential hazard to soil, groundwater or surface water, the requirements in paragraphs 3.2 and 3.3 above may be reduced accordingly.

the bioconcentration factor (BCF) is greater than 1 000 for substances which are readily biodegradable or greater than 100 for those which are not readily biodegradable unless it is clearly established in the risk assessment that under field conditions no unacceptable impact, either directly or indirectly, occurs on the viability of exposed organisms including marine and estuarine organisms after use of the biocidal product according to the proposed conditions of use.

Unexpected, non-serious, suspected adverse reactions which, according to the assessment carried out by the holder of the marketing authorization, can be attributed to the medicinal product and requiring a change to the summary of products characteristics referred to in Article 4 (9) second paragraph of Council Directive 65/65/EEC (2), as last amended by Directive 93/39/EEC (3), and in Article 5 (9) second paragraph of Council Directive 81/851/EEC (4), as last amended by Directive 93/40/EEC, shall be dealt with in accordance with Commission Regulation (EC) No 542/95 of 10 March 1995, as last amended by Directive 93/40/EEC (5), concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93 (6), and with Commission Regulation (EEC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State (7).

In establishing the list of information to be recorded in the registers, account has been taken of the fact that other sets of information - such as the environmental risk assessment, the scientific studies, including studies which demonstrate the safety of the product, including, where available, references to independent and peer-reviewed studies, and to methods for identification and detection, and all other information submitted by the notifier, methods and plans for monitoring the GMO(s) and for emergency response, and results of the post-market monitoring - are in principle accessible according to the relevant provisions of Directive 2001/18/EC, Regulation (EC) No 1946/2003 of the European Parliament and the Council of 15 July 2003 on transboundary movements of genetically modified organisms(2) and Regulation (EC) No 1049/2001 of the European Parliament and the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(3), and therefore need not be recorded.