The clear identification of assets and infrastructure is essential to the evaluation of the port facility's security requirements, the prioritisation of protective measures, and decisions concerning the allocation of resources to better protect the port facility.

4 Such agreements shall be reviewed periodically, taking into account the experience gained as well as any changes in the particular circumstances or the assessed threats to the security of the ships, the port facilities or the routes covered by the agreement.

The criteria of quality, safety and efficacy should enable the risk-benefit balance of all medicinal products to be assessed both when they are placed on the market and at any other time the competent authority deems this appropriate.

The SSA should consider the continuing relevance of the existing security measures and guidance, procedures and operations, under both routine and emergency conditions, and should determine security guidance including:.

However, even a long tradition does not exclude the possibility that there may be concerns with regard to the product's safety, and therefore the competent authorities should be entitled to ask for all data necessary for assessing the safety.

The promotion and development of best practices for risk assessment and for interoperable risk management solutions within public and private sector organisations will increase the security level of networks and information systems in Europe.

Notwithstanding the provisions of paragraph 15.4 of Part A of the ISPS Code, the periodic review of the port facility security assessments provided for in paragraph 1.16 of Part B of the ISPS Code shall be carried out at the latest five years after the assessments were carried out or last reviewed.

For the submission of the required data, the applicant shall consult the 'Guidelines of the European Food Safety Authority for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation'.

The need for a DoS may be indicated by the results of the port facility security assessment (PFSA) and the reasons and circumstances in which a DoS is required should be set out in the port facility security plan (PFSP).

The port facility security assessments shall periodically be reviewed and updated, taking account of changing threats and/or minor changes in the port facility, and shall always be reviewed and updated when major changes to the port facility take place.

3 the procedures needed to assess the continuing effectiveness of security procedures and any security and surveillance equipment and systems, including procedures for identifying and responding to equipment or systems failure or malfunction;.

The assessment report published by the Agency following the evaluation of an application for the establishment of maximum residue limits in accordance with Regulation (EEC) No 2377/90 may be used in an appropriate manner as literature, particularly for the safety tests.

The performance of the air navigation services system as a whole at European level should be assessed on a regular basis, with due regard to the maintenance of a high level of safety, to check the effectiveness of the measures adopted and to propose further measures.

in working environments where explosive atmospheres may arise in such quantities as to endanger the safety and health of workers, appropriate supervision during the presence of workers is ensured in accordance with the risk assessment by the use of appropriate technical means.

Preparation of an effective SSP should rest on a thorough assessment of all issues that relate to the security of the ship, including, in particular, a thorough appreciation of the physical and operational characteristics, including the voyage pattern, of the individual ship.

Preparation of an effective PFSP will rest on a thorough assessment of all issues that relate to the security of the port facility, including, in particular, a thorough appreciation of the physical and operational characteristics of the individual port facility.

If the explosion protection document based on a risk assessment does not state otherwise, equipment and protective systems for all places in which explosive atmospheres may occur must be selected on the basis of the categories set out in Directive 94/9/EC.

The competent authority shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned.

The criteria of quality, safety and efficacy should enable the risk-benefit balance of all veterinary medicinal products to be assessed both when they are placed on the market and at any other time the competent authority deems this appropriate.

Member States shall provide that any person interested in the inclusion in the list referred to in Article 4(1) of an additive, which is already placed on the market in one or more of the Member States, shall submit data for the evaluation of its safety by the Authority by 31 December 2006 at the latest.

By way of derogation from paragraph 1, the monomers and other starting substances listed in Annex II, section B may continue to be used until 31 December 2004 at the latest, pending their evaluation by the European Food Safety Authority (hereinafter referred to as the Authority)."

the explosion protection document includes the identification of the hazards, the evaluation of risks and the definition of the specific measures to be taken to safeguard the health and safety of workers at risk from explosive atmospheres, in accordance with Article 9 of Directive 89/391/EEC;

In such cases, the recognised security organisation undertaking the review and approval of a ship security plan, or its amendments, for a specific ship shall not have been involved in either the preparation of the ship security assessment or of the ship security plan, or of the amendments, under review.

Applications shall include a technical file supplying all the information and justifications necessary for evaluating the safety aspects related to the specific use of surfactants in detergents failing to comply with the biodegradability limits, as set out in Annex III.

The PFSO should undertake an assessment of the particular situation in consultation with the CSO or SSO and agree on appropriate security measures with the ship, which may include completion and signing of a Declaration of Security.

Prior to commencing the SSA, the CSO should ensure that advantage is taken of information available on the assessment of threat for the ports at which the ship will call or at which passengers embark or disembark and about the port facilities and their protective measures.

it shall provide the Commission and the Member States with objective, reliable and comparable information and data on maritime safety, on maritime security and on pollution by ships to enable them to take the necessary steps to improve their actions in these fields and to evaluate the effectiveness of existing measures.

The preparation, adoption and review of implementing rules for interoperability shall take into account the estimated costs and benefits of technical solutions by means of which they may be complied with, with a view to defining the most viable solution, having due regard to the maintenance of an agreed high level of safety.

Member States shall, after a mandatory security risk assessment, decide the extent to which they will apply, by 1 July 2007, the provisions of this Regulation to different categories of ships operating domestic services other than those referred to in paragraph 2, their companies and the port facilities serving them.

Possible acts that could threaten the security of assets and infrastructure, and the methods of carrying out those acts, should be identified to evaluate the vulnerability of a given asset or location to a security incident, and to establish and prioritise security requirements to enable planning and resource allocations.

"(a) the risk-benefit assessment of the veterinary medicinal product is, under the authorised conditions of use, unfavourable, particular regard being had to the benefits for animal health and welfare and to consumer safety, when the authorisation concerns a veterinary medicinal product for zootechnical use;";

providing the competent authorities with any other information relevant to the evaluation of the risks and benefits of a veterinary medicinal product, particularly information concerning post-authorisation safety studies, including information regarding the validity of the withdrawal period or lack of expected efficacy or potential environmental problems.

Each Member State shall draw up the list of port facilities concerned on the basis of the port facility security assessments carried out, and establish the scope of the measures taken to apply the provisions of paragraph 2 of regulation 2 (extent of application to port facilities which occasionally serve international voyages) of the special measures to enhance maritime security of the SOLAS Convention.

"(a) it is clear that the risk-benefit assessment of the veterinary medicinal product is, under the authorised conditions of use, unfavourable, particular regard being had to the benefits for animal health and welfare and to the safety and health benefits for the consumer, when the authorisation concerns a veterinary medicinal product for zootechnical use.";

It is thus necessary to subject such products to an environmental risk-assessment procedure similar to the procedure under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(13), to be conducted in parallel with the evaluation, under a single Community procedure, of the quality, safety and efficacy of the product concerned.

As part of the road safety action programme for the period 2002 to 2010, the Commission shall assess the road safety and road traffic implications of adjusting the speed limitation devices used by category M2 vehicles and by category N2 vehicles with a maximum mass of 7,5 tonnes or less to the speeds laid down by this Directive.

Provision should be made for the quality, safety and efficacy criteria in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Community and it should be possible to assess the risk-benefit balance of all medicinal products when they are placed on the market, at the time of the renewal of the authorisation and at any other time the competent authority deems appropriate.

Such tasks shall include the collection, recording and evaluation of technical data in the fields of maritime safety, maritime security and maritime traffic, as well as in the field of marine pollution, both accidental and deliberate, the systematic exploitation of existing databases, including their cross-fertilisation, and, where appropriate, the development of additional databases.

The conformity assessment shall include safety, e.g. the demonstration that the application software is implemented in a safety platform that has a prior declaration of conformity in a way that achieves safety acceptance according to the Annex A, index 1. This shall also include the demonstration that other software modules possibly installed in the same platform do not interfere with ERTMS/ETCS application.

These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling and production processes and methods.

The Agency shall provide the Member States and the Commission with the technical and scientific assistance needed and with a high level of expertise, in order to help them to apply the Community legislation properly in the field of maritime safety, maritime security within the limits of the tasks defined in Article 2(b)(iv), prevention of pollution caused by ships, to monitor its implementation and to evaluate the effectiveness of the measures in place."

These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, and production processes and methods.

"Technical specification", in the case of service or supply contracts, means a specification in a document defining the required characteristics of a product or a service, such as quality levels, environmental performance levels, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, use of the product, safety or dimensions, including requirements relevant to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, production processes and methods and conformity assessment procedures;

"technical specification", in the case of public supply or service contracts, means a specification in a document defining the required characteristics of a product or a service, such as quality levels, environmental performance levels, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, use of the product, safety or dimensions, including requirements relevant to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, production processes and methods and conformity assessment procedures;

Assessment and verification of safety

an evaluation of the security risks incurred by EU or its Member States;

assessment by customs of the signatory's security procedures,

Any novel excipient shall be the subject of a specific safety assessment.

the plan for initial and follow-on system security or network security test, evaluation and certification;

(c) information of direct relevance to the assessment of the safety of the product;