Assessment and verification of safety

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

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

Whilst substantial equivalence is a key step in the procedure for assessment of the safety of genetically modified foods, it is not a safety assessment in itself.

Undertake an assessment of financial impact of implementing health and safety directives.

Monitoring and assessment of the safety of non-food products and services, including, inter alia:

(b) may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food in accordance with Article 36 of Regulation (EC) No 178/2002;

(b) may ask the appropriate feed assessment body of a Member State to carry out a safety assessment of the feed in accordance with Article 36 of Regulation (EC) No 178/2002;

Scientific advice, risk analysis including comparative assessment and assessment of risk reduction options relevant to consumer health and safety regarding non-food products and services.

Since May 2003, the European Food Safety Authority (EFSA) has taken over from the European Commission the responsibility for the scientific assessment of feed and food safety issues.

Any new excipient does not include the use of materials of human or animal origin for which assessment is required of viral safety data.

Inspections by competent authorities shall include a general assessment of the potential food safety hazards associated with the business.

Where the results of the assessment referred to in Article 3 (2) reveal a risk to workers' health or safety, workers' exposure must be prevented.

Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based.

The manufacturing process of the excipient does not include the use of materials of human or animal origin for which an assessment of viral safety data is required.

However, the possibility of wider applications of smoke flavourings in comparison to conventional smoking has to be taken into account in safety assessments.

Sufficient time should be allowed for the applicant to make available to the Authority the information necessary for the safety assessment of these products.

(i) ab ab comprehensive and systematic safety assessments are carried out before the construction and commissioning of a nuclear installation and throughout its life.

(11) In order to ensure harmonisation, safety assessments should be carried out by the European Food Safety Authority ("the Authority"), established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety fn.

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'.

second, an assessment of the finished plasma-derived medicinal product containing the modified part of the PMF (the two essential parts of the content, plasma origin and plasma quality-safety).

Such assessments shall be well documented, subsequently updated in the light of operating experience and significant new safety information, and reviewed under the authority of the regulatory body;

The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned.

The manufacturing process of the active substance, starting material/reagent/intermediate does not include the use of materials of human or animal origin for which an assessment of viral safety data is required.

(12) The safety assessment of a specific primary product should be followed by a risk-management decision as to whether the product should be entered on the Community list of authorised primary products.

As soon as possible after the amendment of Annexes I, II, III or IV, the Commission shall publish a summary of the assessment of the safety of the substances concerned by the Committee for Veterinary Medicinal Products.

(15) The Community positive list should be established by the Commission after the completion of the safety assessment of all primary products for which sufficient information was submitted during the first phase.

Where the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on:

(14) In order to ensure a harmonised scientific assessment of feed additives, such assessment should be carried out by the European Food Safety Authority, established by Regulation (EC) No 178/2002. Applications should be supplemented by residue studies in order to assess the establishment of Maximum Residues Limits (MRLs).

whereas Directives 73/23/EEC and 89/336/EEC will no longer apply to apparatus within the scope of this Directive, with the exception of protection and safety requirements and certain conformity assessment procedures,

After the initial establishment of the list of authorised primary products, it should be possible for additional primary products to be added thereto by decision of the Commission, following the safety assessment by the Authority.

Each Party reserves the right to make public the results of any conformity assessment, including the conclusions of inspection reports, provided by the other Party, in situations in which public health safety may be affected.

(8) 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 in order to protect public health, maximum residue limits must be established in accordance with generally recognized principles of safety assessment, taking into account any other scientific assessment of the safety of the substances concerned which may have been undertaken by international organizations, in particular the Codex Alimentarius or, where such substances are used for other purposes, by other scientific committees established within the Community;

(10) Provision should be made for the establishment, on the basis of the safety assessment, of a list of primary products authorised for use as such in or on foods and/or for the production of smoke flavourings for use in or on foods within the Community.

The authorisation holder shall inform the Commission immediately of any new scientific or technical information which might affect the assessment of the safety of the authorised primary product or derived smoke flavourings in relation to human health.

whereas therefore it is necessary to provide for an environmental risk assessment of such products similar to that provided for by Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (1), together with the assessment of the quality, safety and efficacy of the product concerned within a single Community procedure;

The Member States shall establish, in accordance with national laws and/or practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment referred to in Article 3 (2) reveal a risk to health or safety.

That notification should contain a technical dossier of information including a full environmental risk assessment, appropriate safety and emergency response, and, in the case of products, precise instructions and conditions for use, and proposed labelling and packaging.

The purpose of this Annex is to establish a framework for the acceptance of electrical products through the recognition of conformity assessment carried out by bodies which comply with the requirements of the other Party, while maintaining the integrity of the safety system in each of the Parties.

(2) The Scientific Committee on Food in its opinion on the safety assessment of salatrims for use as reduced calorie fats alternative as a novel food ingredient, expressed on 13 December 2001, noted that the energy provided by salatrims lies between 5 and 6 kcal/gram.

In selecting the organisations for assessment, the Commission shall pay particular attention to the safety and pollution prevention performance records of the organisation, to the casualty records and to the reports produced by Member States in accordance with Article 12. The assessment may include a visit to regional branches of the organisation as well as random inspection of ships for the purpose of auditing the organisation's performance.

the employer keeps an up-to-date list of the worker engaged in the activities in respect of which the results c the assessment referred to in Article 3 (2) reveal a risk to workers' health or safety, indicating, if the information is available, the exposure to which they have been subjected;

Any new component does not include the use of materials of human or animal origin fir which assessment is required of viral safety data or compliance with the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products.

assessment of the situation, avoiding complications of an accident, summoning assistance, assisting casualties and giving first aid, reaction in the event of fire, evacuation of occupants of a lorry/bus passengers, ensuring the safety of all passengers, reaction in the event of aggression; basic principles for the drafting of an accident report.

(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.

When the assessment referred to in paragraph 2 is carried out, employers shall give particular attention to any effects concerning the health or safety of workers at particular risk and shall, inter alia, take account of the desirability of not employing such workers in areas where they may come into contact with carcinogens.