the e. r. a. should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the GMOs concerned, their intended use and the potential receiving environment, taking into account, i. a., GMOs already in the environment;

The objective of an e. r. a. is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of GMOs may have.

Whereas, to ensure that the information referred to is not made available to more persons than necessary, it is also essential that each Member State should designate not more than one body having responsibility for printing the uniform format for visas, with Member States remaining free to change the body, if need be;

The ERA should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the GMOs concerned, their intended use and the potential receiving environment, taking into account, inter alia, GMOs already in the environment.

(5) In order to enable Member States to follow more closely the processing of their requests, the Commission should be required, once it has all the information it considers necessary for appraising a request, to notify the requesting Member State accordingly and transmit the request, in its original language, to the other Member States.

Whereas this regime provides for a gradual transfer of the maximum residue levels established pursuant to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (7) to Directive 90/642/EEC after technical consideration;

The written concurrence required in Article VI shall include the agreement, of both the State of the former Soviet Union in which the work is to be carried out and the recipient institution, to provide the Centre with access necessary for auditing and monitoring the project, as required by this paragraph.

The overall case-by-case assessment covers the GMO(s) concerned (GMO-by-GMO assessment) and the environment(s) in which the GMO is to be released (for example, site-by-site assessment and region-by-region assessment, if applicable).

To support a case-by-case assessment, it may be useful to classify regional data by habitat area, reflecting aspects of the receiving environment relevant to GMOs (for example, botanical data on the occurrence of wild relatives of GMO plants in different agricultural or natural habitats of Europe).

(28) In order to clarify and explain the Commission's appraisal of concentrations under this Regulation, it is appropriate for the Commission to publish guidance which should provide a sound economic framework for the assessment of concentrations with a view to determining whether or not they may be declared compatible with the common market.

The question arises whether such restrictions are caught by Article 85 (1). They are assessed in this notice with due regard to the purpose of such agreements, which distinguishes them from ordinary patent and know-how licensing agreements.

Member States may at their discretion extend the scope of Memoranda of Understanding established under the programmes referred to in Article 1 to cover other offences for which the customs authorities are competent in addition to drug trafficking.

A competition authority so consulted may take whatever corrective measures under its competition laws it deems appropriate, consistent with its own domestic law, and without prejudice to its full enforcement discretion.

(c) such specifications and rules are established and distributed with an accompanying statement that insurance undertakings are free to accept for insurance, on whatever terms and conditions they wish, other security devices or installation and maintenance undertakings which do not comply with these technical specifications or rules;

(j) "risk management" means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options;

Whereas, further, notification of decisions on export licence applications should be made only after a reflection period enabling the Commission to assess the quantities applied for and the relevant expenditure and if appropriate take particular action on the applications in question;

A procedure should exist whereby a test facility may make representations relating to the outcome of a test facility inspection or study audit for GLP compliance monitoring and/or relating to the action the GLP Monitoring Authority proposes to take thereon.

Where a Member State, as a result of new information or of a reassessment of existing information, considers that a maximum level fixed in the list referred to in Article 1 endangers human or animal health, and therefore requires swift action to be taken, that Member State may temporarily reduce the level in its own territory.

Whereas, for the purposes of fixing export refunds on the products listed in Article 1 (1) of Regulation (EEC) No 1766/92 and in order to avoid the need to introduce checks to detect the slightest variations in quantities of the basic materials and without any noticeable effect on the quality of the product, a standard method of assessment should be adopted;

Activities carried out under this Regulation shall be preceded by environmental and socio-cultural impact assessments, including an assessment of the congruence of the envisaged operations with the development priorities of the forest-dependent people and local communities concerned, as well as analysis of financial and economic feasibility.

(3) In order to protect human and animal health, food and feed consisting of, containing or produced from genetically modified organisms (hereinafter referred to as genetically modified food and feed) should undergo a safety assessment through a Community procedure before being placed on the market within the Community.

The contracting authority may, at its discretion, extend the deadline referred to in Article 30.1 for the submission of tenders by amending the tender dossier in accordance with Article 18, in which case all previous rights and obligations of the contracting authority and tenderers, subject to the previous deadline, will thereafter be subject to the deadline as extended.

To the extent that the creation of a joint venture constituting a concentration pursuant to Article 3 has as its object or effect the coordination of the competitive behaviour of undertakings that remain independent, such coordination shall be appraised in accordance with the criteria of Article 81(1) and (3) of the Treaty, with a view to establishing whether or not the operation is compatible with the common market.

support and further develop, as appropriate, international and intergovernmental programmes and networks or organizations aimed at defining, conducting, assessing and financing research, data collection and systematic observation, taking into account the need to minimize duplication of effort;

If a serious deviation from the GLP principles is identified during a test facility inspection or study audit which, in the opinion of the inspector, may have affected the validity of that study, or of other studies performed at the facility, the inspector should report back to the (national) GLP Monitoring Authority.

As one of the general obligations under the Directive, Article 4(3) requires Member States and, where appropriate, the Commission to ensure that potential adverse effects on human health and the environment, which may occur in particular directly or indirectly, are accurately assessed on a case-by-case basis taking into account the environmental impact according to the nature of the organism introduced and the receiving environment.

during the confidence building programme, where one Party ha's developed sufficient confidence in the evaluation methods and results of the other, it may at its own discretion, establish the relevant document of compliance permitting market access for its own jurisdiction based on the evaluation reports of the other Party without the full submission.

The establishment or centre shall remain under the permanent supervision of the competent authority on the understanding that the need for permanent or periodic presence of the competent authority in a given establishment or centre will depend on the size of the establishment or centre, the type of product manufactured, risk assessment and the guarantees offered in accordance with the fifth and sixth indents of the second subparagraph of Article 14 (1).

Under Directive 2001/18/EC, Member States and, where appropriate, the Commission must ensure that potential adverse effects on human health and the environment, which may occur directly or indirectly through gene transfer from genetically modified organisms (hereinafter GMOs) to other organisms, are accurately assessed on a case-by-case basis in accordance with Annex II to that Directive.

suspension of test facility inspections or study audits of a test facility and, for example and where administratively possible, removal of the test facility from the (national) GLP compliance programme or from any existing list or register of test facilities subject to GLP test facility inspections,

Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has clear proof that the irradiation of certain foodstuffs endangers human health although it complies with the provisions of this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory.

This Article shall not apply to plans and programmes set out in Annex I for which a public participation procedure is carried out under Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment(7) or under Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(8).

In line with the need to ascertain whether efficiencies will lead to a net benefit to consumers, cost efficiencies that lead to reductions in variable or marginal costs fn are more likely to be relevant to the assessment of efficiencies than reductions in fixed costs; the former are, in principle, more likely to result in lower prices for consumers fn.

Whereas it is appropriate that the competent authorities of the Member States be authorised, at their sole discretion, to levy charges for sampling and analysis and for destruction of the product or its return provided that the principle of proportionality is observed in exercising the option of destruction or return and provided also that, in any event, the charges so levied do not exceed the costs incurred;

After careful examination of the arguments, it is considered that the fob comparison does indeed give an undue advantage to companies whose geographical location, if they were located in a market economy country, would prohibit them from exporting bulk products, and has therefore, for the purposes of the definitive determination, changed the basis of the comparison from fob to ex-works.

inspection body, which means an impartial body having the organization, staffing, competence and integrity to perform according to specified criteria functions such as assessing, recommending for acceptance and subsequent audit of manufacturers' quality control operations, and selection and evaluation of products on site or in factories or elsewhere, according to specific criteria;

After the International Office of Epizootic Diseases (OIE) has established a procedure for the classification of countries by category and if it has placed the applicant country in one of those categories, a re-assessment of the Community categorisation of the country concerned in accordance with the first subparagraph of this paragraph may be decided, if appropriate, in accordance with the procedure referred to in Article 24(2).

Before 1 January 2000 and 1 January 2001, producer Member States shall present a summary report of the number of checks carried out under Articles 28, 29 and 30, the number of cases where adjustment was required, with an indication of the information or quantities concerned, and the penalties imposed or under consideration, along with a brief assessment of the control arrangements set up and any difficulties encountered.

(33) Where the application concerns products containing or consisting of a genetically modified organism, the applicant should have the choice of either supplying an authorisation for the deliberate release into the environment already obtained under part C of Directive 2001/18/EC, without prejudice to the conditions set by that authorisation, or of applying for the environmental risk assessment to be carried out at the same time as the safety assessment under this Regulation.

For the products referred to in Article 1(1), the competent authorities may, at their sole discretion, levy charges on the importer for the sampling and analysis of products for compliance with Regulation (EEC) No 737/90. For consignments which exceed the maximum permitted levels, the competent authorities may also recover from their intended importer costs associated with either the destruction of the consignment or its return to the country of origin.

Whereas, after scientific assessment by the Committee for Veterinary Medicinal Products, maximum residue levels must be adopted by a rapid procedure which ensures close cooperation between the Commission and the Member States through the Committee set up under Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), as last amended by Directive 87/20/EEC (5);

(a) However, where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has detailed grounds for establishing that for a given plastic material or article the basic rules laid down in the Annex for migration tests are technically unsuitable or because the actual conditions of use are basically different from the test conditions specified in the table in the Annex, that Member State may, within its territory and only for the particular case, temporarily suspend application of the basic rules referred to in the Annex and permit the use of more appropriate basic rules.

(12) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide or pendimethalin, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC.

or, at the discretion of the vehicle manufacturer limits:

The choice of weight or dynamometer shall be at the discretion of the inspector.

the choice of weight or dynamometer shall be left to the discretion of the inspector.

the term "security" means that which ensures, to the satisfaction of the customs, that an obligation to the customs will be fulfilled.

circumstances Neupopeg should be discontinued at the discretion of the physician and the appropriate tn

However the anterolateral thigh may be used in very young subjects if preferred.

The PFSP should be reviewed at the discretion of the PFSO.