outdoor foliar uses may only be authorised when a risk assessment has demonstrated to the authorising Member State that the use has no unacceptable effects on human and animal health and the environment

When this has been done the risk assessment process has been completed.

Procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in this Directive shall be introduced, in a Regulation of the European Parliament and of the Council.

The Committee was of the opinion that operator risk assessment of flufenacet has been adequately addressed but noted that the sensitising potential of the formulation deserves proper attention.

In the latter case, it is necessary for the evaluation of the environmental risk to comply with the requirements referred to in Directive 2001/18/EC and for the national competent authorities designated by Member States for this purpose to be consulted by the Authority.

(j) "risk management" means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options;

post harvest treatment of potatoes may only be authorised when a risk assessment has demonstrated to the authorising Member State that the discharge of the processing waste from treated potatoes does not have an unacceptable risk to aquatic organisms,

(2) A quantitative assessment of the bovine spongiform encephalopathy (BSE) residual risk in gelatine, tallow and dicalcium phosphate from bovine bones, tallow from fat tissues and tallow from rendered mixtures of tissues is currently being carried out.

risk and/or hazard evaluations, where available;

A probabilistic risk assessment was prepared by the notifier.

In the cases referred to in points 2. 4. 2. 2 and 2. 4. 2. 3, each application for an authorization must be accompanied by a risk assessment taking into account worst-case potential exposure of consumers in the Member State concerned on the basis of good agricultural practice.

any other indication relevant to the risk evaluation of the substance.

a risk assessment undertaken in accordance with Article 15; and

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

'environmental risk assessment' means the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II.

(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.

Each Party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including such measures as requiring risk assessments to be carried out prior to the first release of a living modified organism.

review the risk assessment carried out pursuant to Article 4;

CONOPS and OPLAN will take into account the comprehensive risk assessment.

EFSA has been asked to carry out those detailed risk assessments.

A risk assessment report consistent with Annex III.

In practice, for laboratory scale work where the effect of standard laboratory procedures on exposure are well known, detailed risk assessment of each individual procedure would be unlikely to be required unless a highly hazardous organism was being used.

This will largely be dependent upon the conclusions of the environmental risk assessment.

post harvest fruit, vegetable and potato treatments may only be authorised when an appropriate decontamination system is available or a risk assessment has demonstrated to the authorising Member State that the discharge of the treatment solution does not have an unacceptable risk to the environment and in particular to aquatic organisms,

on the evaluation and control of the risks of existing substances

if the estimated risk arising from a hazard is no longer acceptable;

(17) It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account, including societal, economic or environmental factors, feasibility of controls and the benefit for the animal or for the consumer of animal products.

assessment, management and communication of uncertainty and risk;

Amendments to Annexes I and II as a result of developments in scientific or technical knowledge shall be adopted in accordance with the procedure laid down in Article 7. In particular, when establishing maximum residue levels, account shall be taken of a relevant dietary intake risk assessment and of the number and quality of the data available.';

Risk evaluation of the substances on the priority lists at Community level

Scale is also a factor that must be taken into account in the risk assessment.

the environmental risk assessment and the conclusions required in Annex II, section D;

whereas risk evaluation principles should also be established at Community level;

(5) It is therefore necessary to extend the current risk assessment to an assessment of the risk posed by feed containing limited amounts of meat-and-bone meal.

As far as Council Regulation (EEC) No 2309/93 is concerned, Articles 13 to 24 of this Directive shall not apply to any GMO as or in products as far as they are authorised by that Regulation provided that a specific environmental risk assessment is carried out in accordance with the principles set out in Annex II to this Directive and on the basis of the type of information specified in Annex III to this Directive without prejudice to other relevant requirements as regards risk assessment, risk management, labelling, monitoring as appropriate, information to the public and safeguard clause provided by Community legislation concerning medicinal products for human and veterinary use.

The recommended risk evaluation and strategy shall be forwarded to the Commission by the rapporteur.

an analysis and assessment of risks which cannot be avoided by other means;

(j) A risk assessment report consistent with Annex II to Directive 2001/18/EC.

on measures to assess the residual BSE risk in products derived from bovine animals/on a Community financial contribution for measures to assess the residual BSE risk in products derived from bovine animals

A previous and existing risk assessment report consistent with Annex III.

for each critical point, identified hazards, assessment of risks and control measures,

establish that the final regulatory action has been taken as a consequence of a risk evaluation.

Commission Recommendation 2002/575/EC of 4 July 2002 on the results of the risk evaluation and the risk reduction strategies for the substances:

Commission Recommendation 2002/575/EC of 4 July 2002 on the results of the risk-evaluation and the risk-reduction strategies for the substances:

Whereas the Scientific Veterinary Committee at its meeting on 17 July 1996 endorsed the report of the sub-group for BSE of 26 June 1996, where it recommended that the risk assessment for gelatin established by the Scientific Veterinary Committee on 26 April 1996 be reappraised in the light of the uncertainties as to the inactivation of the BSE agent, due note being taken of the requirements of Decision 96/362/EC;

Potential alternative technologies should be assessed by competent authorities for their risks and benefits.

The system of identification shall be based on risk assessment that takes due account in particular of the following criteria:

(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.

ARisk assessment (incl. macro or micro indicators for selecting sector and/or undertakings).

Commission Recommendation 2002/576/EC of 4 July 2002 on the results of the risk evaluation for the substances: