the various stages of manufacture (including purification procedures) so that an assessment can be made of the reproducibility of the manufacturing procedure and of the risks of adverse effects on the finished products, such as microbiological contamination,

Whereas the Commission has carried out in 1986 and subsequently updated an assessment of possible risks on human health from contaminated foodstuffs with radioactive caesium;

the final regulatory action was based on a risk evaluation involving prevailing conditions within the Party taking the action;

confirm that any assumptions regarding the occurrence and impact of potential adverse effects of the GMO or its use in the environmental risk assessment are correct, and

Seek to identify and record any indirect, delayed and/or cumulative adverse effects that have not been anticipated in the risk assessment,

The decisions referred to in paragraphs 2, 3, 4, 6 and 7 shall be based on a risk assessment, taking into consideration the recommended criteria set out in Annex II, Chapters A and B.

The results of the risk evaluation of the priority substances, and the recommended strategy shall be adopted at Community level in accordance with the procedure laid down in Article 15, and shall be published by the Commission.

Where applicable, applications for marketing authorisations shall include a risk assessment overview evaluating possible risks to the environment due to the use and/or disposal of the medicinal product and make proposals for appropriate labelling provisions.

The draft assessment reports referred to in recital 2 did not identify concerns which can not be mitigated by appropriate risk-management measures at Member State level.

for a specific environmental risk assessment in accordance with Annex II and on the basis of the type of information specified in Annex III without prejudice to additional requirements provided for by the said legislation;

Any alteration in containment conditions indicated as a result of the review of the risk assessment must be applied forthwith to maintain adequate protection for human health and the environment.

The evaluation within the Standing Committee on the Food Chain and Animal Health concluded that the risk would be acceptable, provided appropriate risk-mitigation measures are applied.

In its opinion fn the Committee found for the M2 and M4 metabolites that the risk to non- target terrestrial organisms were not yet adequately assessed and also identified other degradation products for which the risk to non- target organisms needed further evaluation.

to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute risks when weighed against the intended performance of the device.

The draft assessment reports referred to in recital 2 did not identify concerns which can not be mitigated by appropriate risk management measures at Member State level.

Assessment of the risks to the environment presented by such substances and compounds shall be carried out in coordination with the national and Community authorities mentioned in this Directive.

focus on all the potential effects on human health and the environment identified in the risk assessment, taking into account i. e. different locations, soil types, climatic conditions, and

According to Regulation (EC) No 178/2002 of the European Parliament and of the Council(5), as amended by Regulation (EC) No 1642/2003(6), risk management shall take into account the results of risk assessment and other factors legitimate to the matter under consideration, such as detection methods and feasibility of controls for the purpose of avoiding risks from misuse of such substances.

The evaluation within the Standing Committee on the Food Chain and Animal Health concluded that the risk would be acceptable if appropriate risk-mitigation measures were applied.

ensuring that the results of the risk assessments of chemicals are taken fully into account in all areas of Community legislation where chemicals are regulated and to avoid duplication of work;

(9) According to Regulation (EC) No 178/2002 of the European Parliament and of the Council(5), as amended by Regulation (EC) No 1642/2003(6), risk management shall take into account the results of risk assessment and other factors legitimate to the matter under consideration, such as detection methods and feasibility of controls for the purpose of avoiding risks from misuse of such substances.

a technical dossier supplying the information specified in Annex III necessary for carrying out the environmental risk assessment of the deliberate release of a GMO or combination of GMOs, in particular:

Additional studies and information were subsequently provided by the applicant and the risk assessment for the active substance and its degradation products was revised by the rapporteur Member State.

Research undertaken under this priority will be complemented by the development of advanced methods for risk assessment and methods of appraising environmental quality, including relevant pre-normative research on measurements and testing for these purposes.

Apart from the likelihood that the potential harmful characteristics will occur (see Chapter 4. 2. 3, step 3), evaluating the magnitude of the consequences is an important part of risk assessment.

Strict risk assessment and provisioning rules are to be enforced even if these transparency rules unveil further burdens to the corporate and the banking sectors.

Joint Action of 16 June 1997 adopted by the Council on the basis of Article K.3 of the Treaty on European Union, concerning the information exchange, risk assessment and the control of new synthetic drugs

The risk assessment process requires the identification of any potentially harmful properties of the GMM as a result of the genetic modification or any alteration of the recipient organisms' existing properties.

A general principle for environmental risk assessment is also that an analysis of the 'cumulative long-term effects' relevant to the release and the placing on the market is to be carried out.

(11) In order to monitor the benefit/risk assessment, any new information not in the original application and all pharmaco-vigilance information shall be submitted to the competent authority.

- the applicant shall complete an identified programme of studies within a time period specified by the competent authority, the results of which shall form the basis of a reassessment of the benefit/risk profile,

Depending on the results of the initial risk assessment, and in order to ensure compliance with the limit value laid down in Article 8, measurement of asbestos fibres in the air at the workplace shall be carried out regularly.

The evaluation within the Standing Committee concluded that there would be no unacceptable influence of the metabolites TFMBA and TFAA on the environment if appropriate risk mitigation measures are applied.

however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment;

The employer shall be in possession of an assessment of the risk in accordance with Article 9(1)(a) of Directive 89/391/ EEC, and shall identify which measures must be taken in accordance with Articles 5, 6, 7 and 8 of this Directive.

(6) The Annex should therefore be amended on a provisional basis, pending the detailed scientific risk assessments, maintaining a high level of protection for public and animal health and the environment.

new data obtained on the physico-chemical properties, toxicological or ecotoxicological effects where this is likely to be relevant to the evaluation of the potential risk presented by the substance;

Points 3 to 5 of Annex III indicate that the first stage of the risk assessment process for a GMM is to identify the potential harmful properties of the GMM, to determine an initial classification for the GMM.

(4) Some relevant developments have taken place concerning the validation of phthalates migration test methods and the comprehensive risk assessment of these phthalates under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances fn.

Where the nature of residues is affected during processing, a separate risk assessment may need to be carried out under the conditions provided for in point 2. 4. 2. 5.

to coordinate the collection of data in the Member States required for risk assessment by the Scientific Committee for Food in response to unscheduled and urgent questions related to food contaminants

- an environment risk assessment (ERA) report prepared on basis of the information specified in Annexes III and IV of Directive 2001/18/EC and in accordance with Annex II of Directive 2001/18/EC;

The nature and scale of the activity need to be considered in order to estimate the possibility of exposure of humans and the environment and will also affect the choice of appropriate risk management procedures.

(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.

The Commission shall ensure that the current scientific work on a quantitative risk assessment of the residual BSE risk is updated in view of new scientific evidence, and shall in particular ensure the inclusion in this assessment of the residual BSE risks posed by feed containing low amounts of meat-and-bone meal.

Moreover, after marketing authorization, any information not in the original application, pertinent to the benefit/risk assessment, shall be submitted forthwith to the competent authority.

a detailed description and a thorough discussion of the results of the study of the safety of residues in food, and its relevance for the evaluation of potential risks presented by residues to humans.

Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of subtances notified in accordance with Council Directive 67/548/EEC

In order to be able to sum up the toxicity of these different congeners, the concept of toxic equivalency factors ("TEFs") has been introduced to facilitate risk assessment and regulatory control.

The risk assessment shall be kept up to date on a regular basis, particularly if there have been significant changes which could render it out of date, or when the results of health surveillance show it to be necessary.