12.11.85 Official Journal of the European Communities No C 289/5 
II 
(Preparatory Acts) 
COMMISSION 
Amended Draft Council resolution on a programme of action of the European Communities on 
toxicology for health protection (') 
COM(85) 522 final 
(Submitted by the Commission to the Council on 7 October 1985 pursuant to the second paragraph 
of Article 149 of the EEC Treaty) 
(85/C 289/07) 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Preamble and first four recitals unchanged 
Recital 4a 
Whereas toxicology and the related national priorities are 
evolving rapidly, and it will accordingly be necessary to 
update the programme of work each year on the basis of 
contacts between the Commission, the Member States 
and international organizations concerned with toxi­
cology; 
Fifth and sixth recitals unchanged 
Recital 7 
Whereas the present programme will assist the 
development of clinical toxicology and the integration of 
experimental, clinical and analytical data; Recital 7 
Whereas the present programme, the individual sections 
of which are set out in Annex I, will assist the 
development of clinical and analytical data; 
Remaining recitals unchanged 
EXPRESSES THE POLITICAL WILL: 
to take, in keeping with the urgency of the matter and 
bearing in mind what is feasible at national and 
Community level, the measures required so that between 
now and the end of 1990 the following priority actions 
in particular can be undertaken: EXPRESSES THE POLITICAL WILL: 
to take, in keeping with the urgency of the matter and 
bearing in mind what is feasible at national and 
Community level, and within the limits of the 
Community budget specifically allocated for that purpose, 
the measures required so that between now and the end 
of 1990 the following priority actions in particular can be 
undertaken: 
O OJ No C 156, 16. 6. 1984, p. 6. 
No C 289/6 Official Journal of the European Communities 12.11.85 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Final sentence Final sentence 
Requests the Commission to prepare annually, after Requests the Commission to prepare after the first year 
consulting Member States a forward outline of the work and annually thereafter, following consultation with 
it intends to carry out on the implementation of this Member States, a forward outline of work it intends to 
resolution. carry out on the implementation of this resolution in the 
light of the individual actions set out in Annex I and to 
forward this to the European Parliament. 
ANNEX 1 (NEW) 
TOXICOLOGY ACTION PROGRAMME 
Currently planned actions beginning in 1985 
1. Toxicological practice 
1.1. Inventory (on-going data bank) of toxicological testing capabilities and facilities in the European 
Communities. 
1.2. Setting-up of an inventory of toxicological in-vitro methods and their application in testing the 
safety of chemical substances. 
1.3. Intercomparison of some in-vivo mutagenicity tests. 
1.4. Development of a Community instrument for the welfare of laboratory animals used in toxicology 
testing for health protection. 
1.5. Evaluation of the reliability of approximate methods for the determining of LD50. 
1.6. Selection of tests to establish the immunological properties of chemical compounds and 
development of validation procedures. 
1.7. Testing strategies and validation of immunotoxicological tests. 
1.8. Evaluation of the methodology for assessing the effect of chemicals on infants and children, 
including chemicals in breast milk. 
1.9. Evaluation of the methodology for assessing the neuro- and nephrotoxicity of chemicals. 
1.10. Evaluation of the methodology for assessing the effects of chemicals on early ageing and the aged. 
1.11. Transposition and adaptation at European Community level of certain toxicological test methods 
harmonized within the OECD. 
1.12. Assessment of scientific data on the carcinogenicity of a selected number of chemical compounds 
to establish a uniform basis for various Community policies. 
2. Clinical toxicology 
2.1. Poison Control Centres — Assessment of the current functioning and development of the 
preventive and toxicovigilance role. 
2.2. Development of a code of conduct for the application of biological monitoring methods for 
mutagenicity and carcinogenicity in epidemiological studies and in routine. 
2.3. Establishment of the normal range for functioning for certain organs and systems particularly 
susceptible to the action of toxic chemicals, i.e. nervous systems, liver, kidney, etc. 
2.4. In-depth evaluation of the significance for health of the action of chemicals on the immune 
system. 
2.5. Biological effects of nickel and its compounds, including the development of an epidemiological 
approach. 
12.11.85 Official Journal of the European Communities No C 289/7 
3. Training and information 
3.1. Compilation of an inventory (on-going data bank) of toxicology training programmes in the 
European Communities. 
3.2. Definition of tasks and career structure for experimental, clinical and analytical toxicologists. 
3.3. Manpower assessment and development of awareness of the need for qualified toxicologists. 
3.4. Development of curriculum models in toxicology. 
3.5. Promotion of the availability of toxicological information. 
A number of the actions listed above will be carried out jointly with IPCS, WHO/EURO, IARC, World 
Federation of Poison Control Centers, etc. and require more than a year for their completion. As a general 
principle, the financing will be divided as follows: 
— 50 % for Action 1, 
— 25 % for Action 2, 
— 25 % for Action 3.