- lack of data on the exposure of individual population groups to chemical and biological contaminants;

Risk analysis is a process which consists of a scientific evaluation of risks which a foodstuff or its ingredients can pose, assessment of people` s exposure and evaluation of risks on health of an individual or special populations, risks management e.g. by choosing suitable measures for prevention and control of risks, and providing risk communication.

4. risks incurred by the exposure to a single person or a group of persons who represent a unified risk.

2. a detailed method for evaluating and including individual balance-sheet and off-balance-sheet asset items in the calculation of the exposure of the bank, and more detailed measures for taking into account groups of persons specified in the second paragraph of article 79 of the present law in the calculation of exposure

A credit institution's exposure to a client or group of connected clients shall be considered a large exposure where its value is equal to or exceeds 10% of its own funds.

In the field of large exposures, specific standards should also be laid down for exposures incurred by a credit institution to its own group, and in such cases more stringent restrictions are justified than for other exposures.

Excessive concentration of exposures to a single client or group of connected clients may result in an unacceptable risk of loss.

In such cases the consolidated monitoring of the group of undertakings allows for an adequate level of supervision, and does not require the imposition of more stringent limits on exposure.

A credit institution may not incur an exposure to a client or group of connected clients the value of which exceed 25% of its own funds.

Nevertheless taking into consideration specific groups of consumers, especially small children, and assuming worst cases, the exposure to patulin is more significant but still below the PMTDI.

(5) An ad hoc expert group was specifically commissioned by the Authority to advise further on possible risks to infants, the consumer group for which potential exposure to SEM per body weight is likely to be the highest.

In the context of the regulation of large exposures, the aim is to limit the maximum loss that a credit institution may incur through any single client or group of connected clients.

This is the concentration, in terms of initial values, which immobilizes 50 % of the Daphnia in a test batch within a continuous period of exposure which must be stated.

In the present test, acute toxicity is expressed as the median lethal concentration (LC 50 ), that is the concentration in water which kills 50 % of a test batch of fish within a continuous period of exposure which must be stated.

the low-risk off-balance-sheet items referred to in Annex II, to the extent that an agreement has been concluded with the client or group of connected clients under which the exposure may be incurred only if it has been ascertained that it will not cause the limits applicable under paragraphs 1, 2 and 3 to be exceeded.

exposures secured, to the satisfaction of the competent authorities, by collateral in the form of securities other than those referred to in (f) provided that those securities are not issued by the credit institution itself, its parent company or one of their subsidiaries, or by the client or group of connected clients in question.

environmental health risks linked to the food chain (chemical, biological and physical), and combined exposures of authorised substances, including impact of local environmental disasters and pollution on the safety of foodstuffs, with emphasis being placed on cumulative risks, transmission routes to human beings, long-term effects and exposure to small doses, as well as the impact on particularly sensitive groups, and especially children.

The extent of exposure to zaleplon was similar among all groups.

Populations with potentially higher risk of systemic exposure.

Further data addressing this issue are currently awaited.

However, there is a risk of increased exposure in this population (see section 5.2).

degree of exposure of sectors of the population, and in particular sensitive sub-groups,

There was considerable overlap between the ranges of exposures seen in these two populations (see section 4.2).

the human population to which the quantitative and/or qualitative information on exposure applies.

ut diabetes compared to type 2 diabetes and plateaued within 6-12 months of exposure in both groups.

In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the tocilizumab group and 1.5 events per 100 patient years of exposure in the MTX group.

Median exposure in the PREZISTA/ritonavir group was 56.3 weeks.

An exposure assessment shall be conducted for each of the human populations (workers, consumers and man liable to exposure indirectly via the environment) for which exposure to the substance can reasonably be foreseen.

Exposure of VELCADE (dose-normalized AUC and Cmax) was comparable among all the groups (see section 4.2).

If the results of the assessment referred to in Article 3 show that the exposure and/or potential exposure is to a group 1 biological agent, with no identifiable health risk to workers, Articles 5 to 17 and Article 19 shall not apply.

Special populations The influence of renal and hepatic impairment on exposure to porfimer sodium has not been evaluated (see sections 4.2, 4.3 and 4.4).

The risk assessment conducted in accordance with Article 4 shall take account of the following potential toxic effects and populations liable to exposure:

Dilated ureters were also found in the valsartan alone group (exposure 12 times the clinical dose of 160 mg valsartan).

a group comprising individuals whose exposure to a source is reasonably uniform and representative of that of the individuals in the population who are the more highly exposed to that source.

The median duration of exposure to study treatment was significantly longer (44.0 weeks) in the lenalidomide/dexamethasone group as compared to placebo/dexamethasone (23.1 weeks).

Similar changes were found in the valsartan alone group (exposure 8.5– 11.0 times the clinical dose of 160 mg valsartan).

Whereas the Commission welcomed the request from the Council and since 1990 has consulted informally a scientific expert group on occupational exposure limits;

An ad hoc expert group was specifically commissioned by the Authority to advise further on possible risks to infants, the consumer group for which potential exposure to SEM per body weight is likely to be the highest.

Similar changes were also seen in the valsartan alone group (exposure 8.5– 11.0 times the clinical dose of 160 mg valsartan).

Recent findings indicate that exposure in children < 6 years of age may be reduced by about 30 % compared with other age groups.

an emergency plan for the protection of workers from exposure to group 3 or a group 4 biological agent which might result from a loss of physical containment.

With regard to OTC derivatives, additional risk-spreading rules should apply to exposures to a single counterparty or group of counterparties.

Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.

This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups (see section 4.4).

exposure assessment for whichever of the human populations (i.e., workers, consumers and man exposed indirectly via the environment) is likely to be exposed to the substance;

exposure assessment for whichever human population-group (i.e. workers, consumers or man exposed indirectly via the environment) is exposed or likely to be exposed to the substance;

In the case of activities involving exposure to several groups of biological agents, the risk shall be assessed on the basis of the danger presented by all hazardous biological agents present.

In the younger age groups (2-6 years and 7-11 years), exposure (Cmax and AUC) and elimination half-life for the same mg/ kg dose were reduced compared with adolescents.

However, this finding is not clinically relevant as systemic exposure for both elderly and young subjects remained very low from ocular dosing.

Because the total exposure (AUC) of venlafaxine and ODV is similar in poor and extensive metabolisers, there is no need for different venlafaxine dosing regimens for these two groups.