COMMISSION REGULATION (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (1) and, in particular, Article 10 (4) thereof,
Whereas Regulation (EEC) No 793/93 envisages a system of evaluation and control of the risk of existing substances and whereas Article 10 thereof requires that it shall be for the Member States to carry out such risk assessment on existing substances having priority;
Whereas, given that the responsibility for risk assessment lies with the Member States, it is, however, appropriate that the principles of such assessment be adopted at Community level to avoid disparities between Member States which would not only affect the functioning of the internal market but would also fail to guarantee the same level of protection of man and the environment;
Whereas the assessments of risks should be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and the environment to that substance;
Whereas, having regard to the classification of a given substance in accordance with Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (2), as last amended by Commission Directive 93/105/EC (3), the assessment of risks to man should take account of the physico-chemical and toxicological properties of a substance;
Whereas, having regard to its classification in accordance with Directive 67/548/EEC, the assessment of risks to the environment should take account of the environmental effects of a substance;
Whereas the results of a risk assessment should be the principal basis of decisions under appropriate legislation to reduce the risks arising from manufacture, transport, storage, formulation into a preparation or other processing, use and disposal or recovery of existing substances;
Whereas it is appropriate to reduce to a minimum the number of animals used for experimental purposes in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (4);
Whereas the provisions of this Regulation shall be without prejudice to specific Community legislation concerning the safety and protection of health of workers at work, in particular Council Directive 89/391/EEC (5), which places an obligation on employers to evaluate the risks to the health and safety of workers arising from the use of new and existing chemical substances and, as necessary, to take measures to ensure an appropriate protection of workers;
Whereas the measures set out in this Regulation are in accordance with the opinion of the Committee set up pursuant to Article 15 of Regulation (EEC) No 793/93,
HAS ADOPTED THIS REGULATION:
Article 1
Objectives This Regulation lays down general principles for the assessment of the risks posed by existing substances to man and the environment as required by Article 10 of Council Regulation (EEC) No 793/93.
Article 2
Definitions 1. The definitions contained in Article 2 of Regulation (EEC) No 793/93 are applicable to this Regulation.
2. For the purposes of this Regulation:
(a) 'hazard identification' is the identification of the adverse effects which a substance has an inherent capacity to cause;
(b) 'dose (concentration) - response (effect) assessment' is the estimation of the relationship between dose, or level of exposure to a substance, and the incidence and severity of an effect;
(c) 'exposure assessment' is the determination of the emissions, pathways and rates of movement of a substance and its transformation or degradation, in order to estimate the concentrations/doses to which human populations or environmental spheres (water, soil and air) are or may be exposed;
(d) 'risk characterization' is the estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental sphere due to actual or predicted exposure to a substance, and may include 'risk estimation', i.e. the quantification of that likelihood.
Article 3
Principles of risk assessment 1. The risk assessment shall entail hazard identification and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterization. It shall be based on the information on the substance submitted in accordance with Articles 3, 4, 7 (1) and (2), 9 (1) and (2) and 10 (2) of Regulation (EEC) No 793/93 and on other available information and shall normally be conducted in accordance with the procedures set out in Articles 4 and 5 of this Regulation.
2. Notwithstanding paragraph 1, in relation to particular effects, such as ozone depletion, for which the procedures set out in Articles 4 and 5 are impracticable, the risks associated with such effects shall be assessed on a case-by-case basis and the rapporteur shall include a full description and justification of such assessments in the written report submitted to the Commission in accordance with Article 6.
3. In conducting an exposure assessment, the rapporteur shall take into account those human populations or environmental spheres for which exposure to the substance is known or reasonably foreseeable in the light of available information on the substance, with particular regard to manufacture, transport, storage, formulation into a preparation or other processing, use and disposal or recovery.
4. Where a substance for which a risk assessment has already been carried out in accordance with Article 10 of Regulation (EEC) No 793/93 appears again on a priority list, the subsequent risk assessment shall take into account the previous risk assessment(s).
Article 4
Risk assessment: 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:
(a) (i) dose (concentration) - response (effect) assessment, where appropriate;
(ii) 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;
(b) risk characterization.
Article 5
Risk assessment: environment 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 environmental effects, the first stage of which shall be hazard identification. Having conducted the hazard identification, the rapporteur shall proceed to the following sequence of actions which shall be carried out in accordance with the guidelines set out in Annex III;
(a) (i) dose (concentration) - response (effect) assessment, where appropriate;
(ii) exposure assessment for the environmental spheres exposed or likely to be exposed to the substance;
(b) risk characterization.
Article 6
Risk assessment report Having carried out the risk assessment in accordance with Articles 4 and 5, the rapporteur shall prepare a report containing at least the information set out at Annex V together with all data relevant for the risk assessment. This report, together with a summary thereof, shall be forwarded to the Commission in accordance with Article 10 (3) of Regulation (EEC) No 793/93.
Article 7
Final provisions This Regulation shall enter into force on the 60th day following its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 1994.