In consultation with the Member States and assisted by the Advisory Committee on Safety, Hygiene and Health Protection at Work, the Commission shall draw up guidelines on the assessment of the chemical, physical and biological agents and industrial processes considered hazardous for the safety or health of workers within the meaning of Article 2.

Whereas, in order to protect public health, it is necessary to ensure that novel foods and novel food ingredients are subject to a single safety assessment through a Community procedure before they are placed on the market within the Community;

Conversely, where, because of climatic or plant health conditions or other reasons the data obtained in any particular season are of limited value for the assessment of performance, trials in one or more further seasons must be conducted and reported.

"(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.";

in the case of products intended for use as human food or animal feed, risk assessment under Directive 90/220/EEC determines whether the genetic modification is liable to result in any toxic or other harmful effects for human health and the environment,

If the final risk assessment concludes that no public health threat has developed, and no action or only local action is required, the competent public health authorities in each Member State concerned shall inform their counterparts in other Member States and the Commission without delay on the nature and scope of those measures they have taken or intend to take.

Where this is not technically practicable, having regard to the activity and the risk assessment referred to in Article 3, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the health and safety of the workers concerned, in particular by the following measures which are to be applied in the light of the results of the assessment referred to in Article 3:

Prior to any assignment to night work and at regular intervals thereafter, adolescents shall be entitled to a free assessment of their health and capacities, unless the work they do during the period during which work is prohibited is of an exceptional nature.

Table WHO TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15 to 18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for Humans and for Wildlife.

Priority will be given to external quality assurance of microbiological laboratories, quality improvement, proficiency assessment and accreditation schemes to develop networks of reference laboratories and enhance the capabilities of public health laboratories.

However, it has to be stressed that, as a result of new information or a re-assessment of existing information, Regulation (EEC) No 2377/90 can be amended in order to protect human or animal health, in accordance with the procedures provided for in this Regulation.

General surveillance is largely based on routine observation ("look - see" approach) and should be used to identify the occurrence of unforeseen adverse effects of the GMO or its use for human health and the environment that were not predicted in the risk assessment.

It is also considered that the United States has failed to maintain legal and regulatory authority capable of implementing the provisions of the Sectoral Annex for Electrical Safety, in particular as it relates to the reliance of the Occupational Safety and Health Administration on the on-site assessment carried out by Member State Designating Authorities of the Conformity Assessment Bodies located on their territory.

"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.

The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.

It is also considered that the United States has failed to maintain legal and regulatory authorities capable of implementing the provisions of the Sectoral Annex for Electrical Safety, in particular as it relates to the reliance of the Occupational Safety and Health Administration on the on-site assessment carried out by Member State Designating Authorities of the Conformity Assessment Bodies located on their territory.

pregnant workers within the meaning of Article 2 (a) may under no circumstances be obliged to perform duties for which the assessment has revealed a risk of exposure, which would jeopardize safety or health, to the agents and working conditions listed in Annex II, Section A;

Such a structure must provide the flexibility to allow it to advise the Commission on matters falling under established areas of competence as well as on emerging and newly identified health risks and matters not within the competence of other Community risk assessment bodies.

Environmental risk assessment (ERA) is defined in Article 2(8) of Directive 2001/18/EC as "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".

workers who are breastfeeding, within the meaning of Article 2 (c), may under no circumstances be obliged to perform duties for which the assessment has revealed a risk of exposure, which would jeopardize safety or health, to the agents and working conditions listed in Annex II, Section B.

the employer keeps an up-to-date list of the workers engaged in the activities in respect of which the results of 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;

the essential objective of a conformity assessment procedure is to enable the public authorities to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users and consumers;

The systematic assessment of all the dangerous health effects is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of the substance.

"(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;";

In order to protect human and animal health, food and feed consisting of, containing or produced from genetically modified organisms (hereinafter referred to as genetically modified food and feed) should undergo a safety assessment through a Community procedure before being placed on the market within the Community.

Complementary research will focus on: development of advanced methodologies for risk assessment of processes, technologies, measures and policies, appraisal of environmental quality, including reliable indicators of population health and environmental conditions and risk evaluation in relation to outdoor and indoor exposure.

The dangerous substances listed in Annex I shall, where appropriate, be characterized by concentration limits or any other parameter enabling an assessment to be made of the health or environmental hazard of preparations containing the said dangerous substances or substances containing other dangerous substances as impurities.

the complete technical file with the information required in Annex II of Directive 90/220/EEC, extended as necessary to take into account the diversity of sites of use of the additive, including information on data and results obtained from research and developmental releases concerning the ecosystems which could be affected by the use of the additive and an assessment of any risks for human health, animal health and the environment related to the GMO(s) contained in the product including information obtained from the research and development stage on the impact of the release on human health and the environment;

The information provided, taken together with other relevant information, and that for one or more preparations containing the micro-organism, must be sufficient to permit an assessment of its fate and behaviour as well as that of its residual traces and toxins, where they are of significance for human health and/or the environment.

In collaboration with the World Health Organisation's Regional Office for Europe (WHO/EURO), a critical level expressed as an AOT60 (accumulated exposure over a threshold of 60 ppb), i.e. 120 μg/m3, calculated over one year, was adopted as a surrogate for the WHO Air Quality Guideline for the purpose of integrated assessment modelling.

When such a refusal or removal is considered, an assessment of an alternative active substance or substances shall take place to demonstrate that it can be used with similar effect on the target organism without significant economic and practical disadvantages for the user and without an increased risk for health or for the environment.

Whereas authorization of chemical herbicides, and assessment of how their use impacts on human health and the environment, are governed by Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), as last amended by Commission Directive 96/68/EC (4), and not by Directive 90/220/EEC;

The Commission, the national authorities of the Member States and the food assessment bodies referred to in Article 4(3) of Regulation (EC) No 258/97 shall not divulge information identified as confidential pursuant to paragraph 3, except for information that must be made public if circumstances so require in order to protect human health.

Certain activities within the undertaking or establishment, such as maintenance, in respect of which it is foreseeable that there is a potential for significant exposure, or which may result in deleterious effects to safety and health for other reasons, even after all technical measures have been taken, shall be included in the risk assessment.

In order better to protect public health and avoid any unnecessary duplication of effort during the examination of application for a marketing authorization for medicinal products, Member States should systematically prepare assessment reports in respect of each medicinal product which is authorized by them, and exchange the reports upon request.

Where the competent authorities of the Member States have information indicating, on the basis of the risk assessment factors available, that a consignment of products for animal nutrition poses a serious risk to human health, animal health or to the environment they shall verify the information received and, where appropriate, ensure that the necessary measures are taken so that the consignment is not used in animal nutrition, put the consignment under restriction and investigate immediately:

Communication from the Commission (COM(2000) 466 final, as corrected by COM(2000) 466 final/2) on the Guidelines on the assessment of the chemical, physical and biological agents and industrial processes considered hazardous for the safety or health of pregnant workers and workers who have recently given birth or are breastfeeding (Council Directive 92/85/EEC)."

The assessment of the dossiers shows that certain procedures may be required to protect workers from exposure to the additives. Such protection should however be assured by the application of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(3) and the Directives made under it.

The effects of flupyrsulfuron-methyl on human and animal health and the environment have been assessed by France, acting as nominated rapporteur Member State, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant France submitted its draft assessment report concerning the substance to the Commission on 2 December 1997.

Whereas the authorization of chemical herbicides applied to plants and the assessment of the impact of their use on human health and the environment falls within the scope of Council Directive 91/414/EEC of July 1991 concerning the placing of plant protection products on the market (3), as last amended by Commission Directive 96/12/EC (4), and not within the scope of Directive 90/220/EEC;

Article 4(1)(b) of Directive 80/777/EEC (as amended) provides for the separation of iron, manganese, sulphur and arsenic from certain natural mineral waters, using ozone-enriched air treatment, subject to an assessment of this treatment by the Scientific Committee for Food and adoption of the conditions for use of this treatment by the Standing Committee on the Food Chain and Animal Health.

Whereas the authorization of chemical herbicides applied to plants and the assessment of the impact of their use on human health and the environment falls within the scope of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (4), as last amended by Commission Directive 96/68/EC (5), and not within the scope of Directive 90/220/EEC;

Whereas the authorisation of chemical herbicides applied to plants and the assessment of the impact of their use on human health and the environment falls within the scope of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (4), as last amended by Commission Directive 97/73/EC (5), and not within the scope of Directive 90/220/EEC;

Where the results of the risk assessment referred to in Article 4(1) show that, because of the quantities of a hazardous chemical agent present in the workplace, there is only a slight risk to the safety and health of workers, and the measures taken in accordance with paragraphs 1 and 2 of this Article are sufficient to reduce that risk, the provisions of Articles 6, 7 and 10 shall not apply.

If a Member State cannot, within the period allowed in Article 32(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant.

The producer, collective warehouse, dispatching centre, other person or importer listed shall meet, at the request of the said responsible official bodies, specific obligations relating to the assessment or improvement of the plant health situation of the premises and to safeguarding the identity of material until the plant passport is attached pursuant to Article 10 (2) of Directive 77/93/EEC;

If, within the period laid down in Article 28(4), a Member State cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet on the grounds of potential serious risk to public health, it shall give a detailed exposition of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant.

Denmark considers that the proposed testing regime to demonstrate freedom from extraneous agents is insufficient to ensure that Bovilis BVD would not interfere with their national eradication campaigns for certain animal diseases and that therefore the benefit: risk assessment for Bovilis BVD is negative and authorisation of the product would represent a potential serious risk to animal health.

Without prejudice to Article 10 of Directive 89/391/EEC, workers within the meaning of Article 2 and workers likely to be in one of the situations referred to in Article 2 in the undertaking and/or establishment concerned and/or their representatives shall be informed of the results of the assessment referred to in paragraph 1 and of all measures to be taken concerning health and safety at work.

human health For each substance appearing on the priority lists in accordance with Article 8 of Regulation (EEC) No 793/93, the rapporteur shall carry out a risk assessment in relation to its effects on human health, the first stage of which shall be hazard identification which shall address, at least, the properties and potential adverse effects specified in Annexes I A and II A. Having conducted the hazard identification, the rapporteur shall take the following sequence of actions, which shall be carried out in accordance with the guidelines set out in Annexes I B and II B: