The initial stages in assessing alternatives to dumping should, as appropriate, include an evaluation of:

The Committee shall appoint one of its members to act as rapporteur and to undertake an initial evaluation of the application.

A tariff quota shall be considered as critical as soon as 75 % of the initial volume has been used, or at the discretion of the competent authorities.

initial environmental review if appropriate, environmental management system, environmental audit and its results and the environmental statement;

The environmental verifier shall, in particular, investigate in a sound professional manner, the technical validity of the initial environmental review, if appropriate, or audit or other procedures carried out by the organisation, without unnecessarily duplicating those procedures.

Reports of pharmaco-kinetic and initial tolerability studies in healthy subjects and in patients, reports of pharmaco-kinetic studies to assess effects of intrinsic and extrinsic factors, and reports of population pharmaco-kinetic studies shall be provided.

An initial assessment as provided for in Article 6 shall be carried out.

Upon receipt of the request, the Member State referred to in Article 4 (1) shall ensure that an initial assessment is carried out.

When the initial assessment of the request is carried out pursuant to Article 4(1) of Regulation (EC) No 258/97, the Commission shall make the following information available to the public:

the preparation of the initial assessment reports provided for in Article 6.

Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgment.

The Commission shall make the initial assessment report available to the public, except for any information identified as confidential pursuant to Article 1(3), in the following way:

After intravenous initiation of treatment, the treatment can be switched to oral treatment with tablet or suspension if clinically indicated at the discretion of the physician.

Oral olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.

The Commission shall forward to the Member States without delay a copy of the summary provided by the applicant and the name of the competent body responsible for carrying out the initial assessment.

Each Member State shall notify to the Commission the name and address of the food assessment bodies responsible in its territory for preparing the initial assessment reports referred to in Article 6 (2).

when there are no objections pursuant to Article 6(4) of Regulation (EC) No 258/97. the initial assessment report shall he made available to the public after the expiry of the period of 60 days referred to in that Article and after the time necessary for the information of the applicant;

The initial assessment report shall be drawn up within a period of three months from receipt of a request meeting the conditions laid down in paragraph 1, in accordance with the recommendations referred to in Article 4 (4), and shall decide whether or not the food or food ingredient requires additional assessment in accordance with Article 7.

System 2 +: see Directive 89/106/EEC Annex III.2.(ii), first possibility including certification of factory production control by an approved body on the basis of initial inspection of factory and of factory production control as well as of continuous surveillance, assessment and approval of the factory production control.

System 2+: see Directive 89/106/EEC Annex III(2)(ii), first possibility including certification of factory production control by an approved body on the basis of initial inspection of factory and of factory production control as well as of continuous surveillance, assessment and approval of the factory production control.

System 2+: See Directive 89/106/EEC, Annex III(2)(ii), first possibility including certification of factory production control by an approved body on the basis of initial inspection of factory and of factory production control as well as of continuous surveillance, assessment and approval of the factory production control.

when, pursuant to Article 7 of Regulation (EC) No 258/97, an authorisation decision is required, the initial assessment report shall wherever possible be made available to the public at the same time the opinion of the Scientific Committee for Food is given or, if no such opinion is required, at the time that the decision is published in the Official Journal of the European Communities.

System 2+: see Annex III(2)(ii) to Directive 89/106/EEC, first possibility, including certification of factory production control by an approved body on the basis of initial inspection of factory and of factory production control as well as of continuous surveillance, assessment and approval of the factory production control.

See Directive 89/106/EEC, Annex III(2)(ii), first possibility, including certifcation of the factory production control by an approved body on the basis of initial inspection of factory and of factory production control as well as of continuous surveillance, assessment and approval of factory production control.

See Directive 89/106/EEC, Annex III(2)(ii), first possibility, including certification of the factory production control by an approved body on the basis of initial inspection of factory and of factory production control as well as of continuous surveillance, assessment and approval of factory production control.

To that end, it shall notify the Commission of the name of the competent food assessment body responsible for preparing the initial assessment report, or ask the Commission to arrange with another Member State for one of the competent food assessment bodies referred to in Article 4 (3) to prepare such a report.

Food additives, if prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food, or if different from those mentioned in this Directive, should be submitted for safety evaluation by the Scientific Committee for Food with emphasis on the purity criteria.