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COM (85) 799 
 
 
 
Vol. 1985/0 266 
  
 
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COMMISSION OF THE EUROPEAN COMMUNITIES
COM(85) 799 final 
Brussels, 13 December 1985
ACTION AGAINST CANCER
(Communication from the Commission to the Council)
COM(85) 799 final
\

-  1 -
6~v
Introductory Statement
1. The European Council in Milan (28-29 June 1985) expressed  
interest in a French memorandum calling for, and  
emphasizing the value of, a coordinated European action  
against cancer, making full use of existing structures.
A letter was subsequently sent on the same subject by the  
President of the Council of Ministers of Italy to the  
Heads of States and Governments and to the President of  
the Commission of the European Communities.
The European Council in Luxembourg (2-3 December 1985)  
took note of a French-Italian communication on this  
subject and asked that the Ministers of Foreign Affairs  
should examine at their next meeting the best way of  
giving a rapid and effective follow-up to this initiative.
The Commission welcomes these initiatives and fully shares  
the views expressed in the above-mentioned documents.
Community Actions
2. The Commission has so far undertaken a series of actions
which, in various ways, contribute to the fight against
1cancer.
3. As regards prevention.  Directives have been adopted by  
Council which have a direct bearing on cancer induction by  
physical and chemical agents. The "Basic safety standards  
for the health protection of the general public and  
workers against the dangers of ionizing radiation" and the 
"Protection of workers from risks relating to exposure to
An "Overview" of these actions is attached in annex.

-  2 -
chemical, physical and biological agents" including  
protection from asbestos and vinyl chloride, are examples  
of such Directives.
4. In the light of the conclusions of the European Council in  
Milan, the Comission has submitted to the Council a  
Proposal for a Resolution on a Programme of Action of the  
European Communities on Cancer Prevention. This programme  
aims at improving the health and quality of life of the  
citizens within the Community and at providing a setting  
in which existing actions and future initiatives in the  
field of prevention can be made more coherent. The  
objectives of the programme are to halt the increase of  
cancer, to establish health strategies forfhose factors to  
which cancer is attributed, to facilitate development of  
population screening and treatment, to improve the  
monitoring of the health and specific groups of the  
population in order to identify risk factors for cancer,  
and to collaborate with international and national  
organization to these ends and to the application of the  
results of cancer research.
Prevention and therapy of cancer must undoubtedly contain  
an important element of public and professional
information and education. The draft Resolution therefore  
proposes that due attention be given to these. The  
Commission will seek to act jointly with national
authorities.
This proposal is currently under discussion in Council.
5. In the field of research,  a series of actions in the areas  
of cancerogenesis and cancer therapy have been supported  
in Community research programmes, mainly the Environmental  
Protection, Radiation Protection and Medical Research  
programmes of the EEC and the ECSC. In this context, the

- 3 -
Coordinating and Data Center of the European Organization  
for Research on Treatment of Cancer (EORTC) has been given  
financial support.
The Commission has announced to Council that "a  
coordination action on cancer, in agreement with the  
conclusions of the Milan Summit" will be embodied into  
the proposal for a renewal of its Medical Research  
Programme, to be presented to Council in early 1986. This  
clearly identifies a "Cancer" action which will focus on  
three areas: early detection and diagnosis,  
mu Iti-modality treatment (including the development and  
improvement of clinical trials in organ-oriented  
projects), and transfer of research results. In  
conducting this programme, the Commission will seek to  
make an optimal use of existing structures.
Cone Lusions
Important national and international efforts are underway  
at present. Community actions have been described above.
New initiatives have been proposed at the recent European  
Councils. Given the desirability, therefore, of  
appropriate consultation and coordination b  .'.ween all L it e  
parties concerned, it appears that the Community framework  
offers a possibilty for the development of a coherent  
"Europe against Cancer" action which would optimize the  
benefits of the various efforts already being undertaken,  
without' interfering in their efficient functioning or  
duplicating existing work.
As a first step, the Commission intends to host an ad-hoc  
expert committee, composed of high-level scientists and  
cancer specialists, in order to make recommendations on  
the ways and means of implementing a European action  
against cancer.
C0MC85) 530 final.

- 4 -
The Council is therefore requested:
to decide on the Launching of an action to be known as  
"Europe Against Cancer", aimed at ensuring the optimum  
coordination of all initiatives currently being taken  
in Europe as well as the study of new initiatives in  
the fields of prevention and research (including  
therapy);
- to take note of the Commission's intention to convene
the above-mentioned ad-hoc expert committee and to report back to Council with
specific proposals based on the recommendations of the  
Committee within a period of 3 months;
- to undertake to examine as a matter of priority the  
existing Commission proposals on prevention as well as  
the forthcoming proposals on research with a view to  
their rapid adoption.

COMMISSION  
OF THE
EUROPEAN COMMUNITIES
DIRECTORATE-GENERAL  
FOR EMPLOYMENT, SOCIAL AFFAIRS  
AND EDUCATION•  ©russe Is.•2
1 November-1985·
DRAFT (2) 
(Original :  E.)
AN OVERVIEW OF
EXISTING COMMUNITY ACTIONS AGAINST CANCER
(Working Document from Commission Services)
Provisional address:  
Rue de la Loi 200  
B-1049 BrusselsTéléphona:
Telephone exchange: 235 11 11  
Direct line: 235 ___Telex:
CO
MEU B 21877Telegraphic address:  
COMEUR Brussels

.0. The need to protect workers and the public against the long-term
effects, in particular cancer, of dangerous chemical, biological and  
physical agents has been the objective of many actions at Community  
level. These have been contained in a number of different sectorial  
activities, namely radiation protection, occupational health and  
safety, internal market, agriculture and environment. Research  
programmes and epidemiological and statistical studies have been  
undertaken in support these actions. References and additional  
information are given in the annexes.

2.0. RADIATION PROTECTION
2.1. The Treaty establishing the European Atomic Energy Community prescribes  
that basic standards for the protection of the health of the general  
public and workers against the dangers of ionising radiation - princi­
pally cancer - shall be laid down. To this end in 1959 the Council  
adopted the first Directive laying down such basic standards and this  
was last updated in Directives of 1980 and 1984. In addition, in 1984  
a Directive layed down basic measures for the protection of patients  
undergoing medical examination or treatment with X-rays. Ongoing  
work is concerned with protection from naturally occuring radiation,  
radioactive discharge and waste management and transport. This work  
.  is assisted by a group of experts as prescribed in the Treaty. ·

3.0. OCCUPATIONAL HEALTH AND SAFETY
3.1. The first programme of action on safety and health at work, adopted
in 1978, required the development of a preventive and protective action  
for substances recognized as being carcinogenic and this was reempha­
sised in the second programme for the years 1984-88. Council has  
adopted Directives on the protection of workers from risks relating to  
exposure to chemical, physical and biological agents and in particular  
to protection from asbestos and vinyl chloride. Council is currently  
considering the proscription of four carcinogenic substances and  
subsequent measures will address benzene, acrylonitrile, arsenic and  
nickel compounds. The scientific and technical bases for such actions  
have been determined in a series of studies. This work is assisted  
by an Advisory Committee established by Council in 1974.

4,0. INTERNAL MARKET
4.1. Community rules relating to medicinal products safeguard public health  
whilst ensuring that the development of the pharmaceutical industry and  
trade in medicinal products will not be hindered. Since 1975 Directives  
have layed down carcinogenicity and mutagenicity testing of human
and veterinary drugs. This work is assisted by a Committee for  
Proprietary Medicinal Products.
4.2. Food additives are subject to stringent testing and regulation. The  
Scientific Committee for Food has established guidelines for the
'Safety assessment of food additives which include provisions for  
testing of chronic toxicity and carcinogenicity.
Ì

5.0.AGRICULTURE
5.1. Since 1970, Council Directives have controlled by means of positive  
lists the use of additives, contaminants and compounds resulting from  
developments in the biotechnology of feedingstuffs.  The use of  
compounds involving potential carcinogenic risks is discarded. The  
assessment of the safety of animals, human beings and environment is  
done by committees of experts of the Member States working in close  
collaboration with Commission services. The Commission is assisted  
in this task by the Scientific Committee for Animal Nutrition.
5.2. At a Community level measures have existed since 1976 controlling  
levels of pesticide residues in and on fruit and vegetables, and  
toeasures were adopted in 1979 to prohibit the marketing and use of  
certain plant protection products. Proposals are at present under  
examination in the Council to extend the scope of the foodstuffs
.. covered.
5.3. The Commission before making proposals to the Council consults its  
Scientific Committee for Pesticides and national experts on the  
possible toxicological effects of the substances including carcino­
genicity, and acts accordingly.

6.0. ENVIRONMENT
6.1. A number of carcinogenic, mutagenic and teratogenic cubstances are  
being studied within the framework of the Directives relating to the  
classification and labelling of dangerous chemicals. The classification  
of these substances is discussed in a working group of governmental  
experts and, in the case of divergent opinions amongst the Member States,  
by a group of highly qualified "specialized experts".
6.2. For the purpose of classification and labelling, carcinogenic substances
are divided into three categories. The label is then decided according  
to which category the substance is placed in, taking into account  
other dangerous properties. Substances in categories 1  and 2 are  
ascribed the risk phrase "May cause cancer" and the symbol "toxic"
(skull and crossbones); substances in category 3 are ascribed the risk  
,, phrase "Possible risk of irreversible effects" and the symbol "harmful"  
(St. Andrew's cross).
6.3. After the approval of the Technical Progress Committee, the labelling  
requirement is published as a Commission Directive. This Committee  
has just approved the labelling of 27 substances of categories 1  or 2.
A further 15 suspected carcinogenic substances are under discussion.
Some Member States have announced that they wilt submit to the working  
group., other suspected carcinogens for classification and labelling. .

7.0. TOXICOLOGY
.1. The Scientific Advisory Committee to examine the toxicity and ecotoxicity  
of chemical compounds has presented advice on the grouping of carcino­
genic, teratogenic and mutagenic substances for the purposes of  
identification and product handling. The Committee has expressed an  
opinion on 17 such substances or classes of compounds and this work is  
ongoing.
.2. The proposal for a Council Resolution on an action programme on toxicology  
for health protection makes reference to the development of new'methods  
for determining the long-term effects of chemical substances including  
,  their carcinogenic and mutagenic potential and quantitative risk
estimations. It stresses the health importance of immunotoxic effects  
and the relationship between immune depression and cancer.
I

8.0. PUBLIC HEALTH
8.1. A number of pilot projects have been undertaken relating to tobacco  
and alcohol consumption and an ongoing programme of workshops and  
conferences has dealt with technical problems in health education and  
monitoring the health of the population.
?
I

9.0.STATISTICS
9.1The Statistical Office collates data from the Member States on mortality  
from cancer. In collaboration with Commission Services and the  
International Agency for Research on Cancer, a cancer atlas of the  
European Community is under preparation.
9.2.The principles and practice of protection of personal data in a research- l ,  
dependent environment was the subject of a report on "The Confidentiality j 
of Medical Records" presented in 1984. ' !
Ii

10.0. RESEARCH
10.1. In the third sectorial research and development programme of the  
European Economic Community in the field of medical and public health  
research for the period 1982-86, projects have concerned the development  
of new medical technologies for early detection and diagnosis, eg.  
positron emission tomography, identification and characterisation of  
biological tissues by NMR, automated cytology. These techniques are  
applicable to various cancers. In addition, financial support has
been given to the Coordinating and Data Center of EORTC.
10.2. In the fourth ECSC occupational medicine research programme special  
reference is made to cancer and the identification of increased risk  
through research into the carcinogenicity of atmospheric pollutants.
Work has focussed on the risk of lung cancer from welding fumes and this  
has involved bioassays of pollutants with in vitro and in vivo testing,  
clinical and epidemiological studies. This work will be extended in the  
fifth programme 1987-91.
10.3. In the field of radiation protection, past programmes have addressed  
fundamental cytological and biochemical effects of ionising radiation.
The current five-year programme, 1985-1989, denotes an important part  
of its resources to radiation carcinogenesis. It is concerned with  
the possible carcinogenic and mutagenic effects of low dose exposures  
and effects of naturally occurring radon and other sources. Research  
areas are :  molecular alterations, cellular transformation, experimental  
carcinogenesis, biological effects of incorporated radionuclides and  
human observations.
10.A. In the third environmental protection programme (1981-1985) research
relating to cancer is concerned with the assessment of the mutagenic and  
carcinogenic potential of environmental chemicals and with the carcino­
genicity of chemicals and fibrons materials.
10.5. Each research programme has a committee for management and coordination  
to assist the Commission in the implementation of the Council's  
Dec i  s i  ons .
f

ANNEX OF REFERENCES

RADIATION PROTECTION
Community instruments
1. Directive 1959 laying down the basic safety standards for the health  
protection of the general public and workers against the dangers of  
ionizing radiation - O.J. No 11, 20.2.1959
2. Directive 62/1,633/Euratom - 5.3.1962 -
3. Directive 66/45/Euratom - 27.10.1966
4. Directive 76/579/Euratom - 1.6.1976
5. Directive 80/836/Euratom - 15.7.1980 - O.J. L.246 - 17.9.1980
6. Directive 84/467/Euratom - 3.9.1984, amending Directive 80/836/Euratom
as regards the basic standards for the health protection of the general  
public and workers against the dangers of ionizing radiation -
O.J. L.265 - 5.10.1984. .'  ......‘....
Di
 recti ve -84/466/Euratom - 3.9.1984, laying down-bas-ie measures- for the  
radiation protection of persons undergoing medical examination or  
treatment - O.J. L.265 - 5.10.1984.
ARTICLE 31,“  EURATOM TREATY, states :
The basic standards shall be worked out by the Commission after it has obtained  
the opinion of a group of persons appointed by the Scientific and Technical  
Committee from among scientific experts, and in particular public health  
experts, in the Member States.
!

OCCUPATIONAL HEALTH AND SAFETY
Community instruments
1. Resolution of 29.6.1978 on an action programme of the European Communities  
on safety and health at work - O.J. C.165 - 11.7.1978.
2. Resolution of 27.2.1984 on a second programme of action of the European  
Communities on safety and health at work - O.J. C.67 - 8.3.1984.
3. Directive 78/610/EEC on the approximation of the laws, regulations and  
administrative provisions of the Member States on the protection of the  
health of workers exposed to vinyl chloride monomer - O.J. L.197 - 22.7.1978.
4. Directive 80/1107/EEC of 27.11.80 on the protection of workers from the  
risks related to exposure to chemical, physical and biological agents at  
work - O.J. L.327 - 3.12.1980.
5. Directive 83/477/EEC of 19. 9.1983 on the protection of workers from
the risks related to exposure to asbestos at work - O.J. L.263 - 24.9.1983.
6. Proposal for a Directive on the protection of workers by the proscription  
of specified agents and/or work activities - O.J. C.270 - 10.10.1984.
7. Proposal for a Directive on the protection of workers from the risks related  
to exposure to benzene at work.
8. Council Decision 74/325/EEC of 27.5.1974 setting up an Advisory Committee  
on safety, hygiene and health protection at work - O.J. L.185 - 9.7.1974.

INTERNAL MARKET
Community instruments
1. Directive 75/318/EEC of 20.5.1975 on the approximation of the Laws of  
Member States relating to analytical, pharmaco-toxicological and clinical  
standards and protocols in respect of the testing of proprietary medicinal  
products. O.J. L.147 - 9.6.1975, as modified by Directive 83/570/EEC -  
O.J. L.332 - 28.11.1983.
2. Recommendation 83/571/EEC of 26.10.1983 concerning tests relating to the  
placing on the market of proprietary medicinal products.
3. '  pirective 81/852/EEC of 28.9.1981 on the approximation of the Laws of
Member States relating to analytical, pharmaco-toxicological and clinical  
standards and protocols in respect of the testing of veterinary medicinal  
products - O.J. L.317 - 6.11.1981.
4. Proposals for Directives amending Directives 75/318/EEC and 81/852/EEC -  
O.J. C.293 - 5.11.1984.
5. Recommendation 80/1089/EEC of 11.11.1980 concerning tests relating
to the safety evaluation of food additives. O.J. L.320 - 27.11.1980.
6. Committee for Proprietary Medicinal Products. Directives 75/318/EEC and  
83/570/EEC.
7. Committee for Proprietary Veterinary Products. Directive 81/851/EEC.  
Publications
1. The rules governing medicaments in the European Community,
July 1984, ISBN 92/825/4529-034.
2. Guidelines for the safety assessment of food-additives.
Report of the Scientific Committee for Food - 22.2.1980.
3. Studies on anti-neoplastic agents (in preparation).

AGRICULTURE
Community instruments
1. Council Directive 70/524/EEC of 14.12.1970 concerning the use of  
additives in feedingstuffs.
2. Council Directive 74/63/EEC of 17.12.1973, concerning maximum levels  
of undesirable substances and products in feedingstuffs.
3. %  Council Directive 82/471/EEC of 30.06.1982, concerning certain products
used in feedingstuffs.
4. Council Directive 76/895/EEC of 9.12.1976, relating to the fixing of
·· maximum levels of pesticides in and on fruit and vegetables.
5. Council Directive 79/117/EEC of 8.2.1979 concerning the prohibition of
the placing on the market and use of plant protection products concerning  
certain active substances.

ENVIRONMENT
Community instruments
1. Council D irectly« 67/548/EEC of 27 June 1967 on the approximation of  
the law*, regulations and administrativ* provisions relating to the  
classification, packaging and labtlUng of dangerous substances.
O.J. 196 of 16.8.1967.
2. Council Directive 79/831/EEC of 18 September 1979 amending for the  
sixth time Directive 67/548/EEC.
O.J. L 259 of 15.10.1979.
3. Comm'1s.s1on Directive 83/467/EEC of 29.7.1983 adapting to technical  
progress for the fifth time Council Directive 67/548/EEC.
O.J. L 257 of 16.9.1983.
A. Commission Directive 84/449/EEC of 25.4.1984 adapting to technical  
progress for the sixth time Council Directive 67/548/EEC.
O.J. L 251 of 19.9.1984.
5. Proposal for a Council Directive on the approximation of the laws,  
regulations and administrative provisions of the member States relating  
to the classification, packaging and labelling of dangerous  
preparations.
O.J. C 211 of 22.8.1985.
6. Resolution of 19.5.1981 on a second progremm* of the European Sconomlo  
Community for a consumer protection and Information policy.
O.J. C 133 of 3.6.1981.
7. Resolut1on .  of 7.2.1983 on the continuation and Implementation of a  
European Community policy and action programme on the environment.
O.J. C 46 of 17.2.1983.
Opinions of government experts and "specialized experts" on labelling of  
suspected carcinogenic substances.

STATISTICS
Community Instrument
The Confidentiality of Medical Records" - The principles and practi.ce  
of protection in a research-dependent environment  
EUR.9471 - 1984.

RESEARCH
Community instruments
1. Decision, 17.8.82, adopting a sectorial research and development programme  
of the European Economic Community in the field of medical and public  
health research - concerted action (1982-1986) - O.J. L.248 - 24.8.1982.
2. Decision, 3.2.1981, adopting a fourth ECSC medical research programme on  
the effects on the health of workers of physical and other environmental  
factors at the workplace - O.J. C.307 - 27.11.1981.
3. Decision, 18.3.1980, adopting a multi-annual research and training  
programme for the European Atomic Energy Community in the field of  
radiation protection (1980-1984) - O.J. L.78 - 25.3.1980.
4. Decision, 12.3.1985, adopting a multi-annual research and training  
programme for the European Atomic Energy Community in the field of  
radiation protection (1985-1989) - O.J. L.83 - 25.3.1985.
5. Decision, 3.3.1981, adopting a sectorial R. & D. programme in the  
field of environment (1981-1985) - O.J. L.101 - 11.4.1981.