ARCHIVES HISTORIQUES 
DE LA COMMISSION 
 
 
 
COLLECTION RELIEE DES 
DOCUMENTS "COM" 
 
 
 
 
COM (85) 799 
 
 
 
Vol. 1985/0 266 
  
 
Disclaimer  
Conformém ent au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983 
concernant l'ouverture au public des archives historiques de la Communauté économique 
européenne et de la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983, 
p. 1), tel que modifié par le règlement (CE, Euratom) n° 1700/2003 du 22 septembre 2003 
(JO L 243 du 27.9.2003, p. 1), ce dossier est ouvert au public. Le cas échéant, les documents 
classifiés présents dans ce dossier ont été déclassifiés conformément à l'article 5 dudit 
règlem ent. 
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 
concerning the openi ng to the public of the historical archives of the European Econom ic 
Community and the European Atomic Energy Communit y (OJ L 43, 15.2.1983, p. 1), as 
amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243, 
27.9.2003, p. 1), this f ile is open to the public. Where necessary, classified documents in this 
file have been declassified in conformity with Article 5 of the aforementioned regulation.  
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom  1. 
Februar 198 3 über die Freigabe der historischen Archive der Europäischen  
Wirtschaftsgemeinschaft und der Europäischen Atomgem einschaft (ABI. L 43 vom  15.2.1983,  
S. 1), geändert durch die Verordnung (EG, Euratom) Nr. 1700/2003 vom 22. Septem ber 2003  
(ABI. L 243 vom 27 .9.2003, S. 1), ist diese Datei der Öffentlichkeit zugänglich. Soweit  
erforderlich, wurden die Verschlusssachen in dieser Datei in Übereinstimmung mit Artikel 5  
der genannten Verordnung freigegeben.  
COMMISSION DES COMMUNAUTES EUROPEENNES
C0MC85) 799 final
Bruxelles, 13 décembre 1985
l'action contre le cancer
COMMUNICATION DE LA COMMISSION AU CONSEIL

1.
DECLARATION PRELIMINAIRE
1. Le Conseil européen tenu à Milan les 28 et 29 juin 1985 s'est 
rallié à un mémorandum français mettant l'accent sur l'intérêt 
qu'il y a à lancer un programme d'action européen contre le can­
cer, en exploitant au maximum les structures existantes.
Le président du Conseil des ministres italien a fait parvenir 
ensuite sur la même question une lettre aux chefs d'Etats et de 
gouvernements ainsi qu'au président de la Commission des 
Communautés européennes.
Le Conseil européen tenu à Luxembourg les 2 et 3 décembre 1985 a 
pris note d'une communication franco-italienne sur la question 
et a demandé à ce que les ministres des affaires étrangères exa­
minent au cours de leur prochaine réunion le moyen le plus adé­
quat de donner une suite rapide et efficace à cette initiative.
La Commission se réjouit de ces initiatives et partage entière­
ment les points de vue exprimés dans les documents mentionnés 
plus haut.
ACTIONS COMMUNAUTAIRES
2. La Commission a entrepris jusqu'à présent toute une série 
d'actions qui contribuent de différentes manières à la lutte 
contre le cancer (1).
3. En ce qui concerne la prévent ion, 1e Conseil a adopté des direc­
tives qui concernent directement les effets cancérigènes de 
différents agents chimiques et physiques. On peut citer par ex­
emple, les directives portant sur "les normes de base relatives 
à la protection sanitaire de la population et des travailleurs 
contre les dangers résultant des rayonnements ionisants" et "la 
protection des travailleurs contre les risques liés à une expo­
sition à des agents chimiques, physiques et biologiques pendant 
le travail" (notamment l'amiante et le chlorure de vinyle).
(1) On trouvera ci-joint un résumé de ces actions.

2.
4. A La Lumière des concLusions du ConseiL européen de Mi Lan, La 
Commission a présenté au ConseiL une proposition de résoLution 
du Consei L  concernant un programme d'action des Communautés 
européennes en matière de prévention du cancer.  Ce programme a 
pour but d'améLiorer La santé et La quaLité de La vie des 
citoyens de La Communauté et de définir un cadre pour une pLus 
grande cohérence des actions en cours et des initiatives futures 
en matière de prévention. Le programme a pour objectifs de 
stopper L'évoLution du cancer, de définir des stratégies sani­
taires touchant Les facteurs vraisembLabLement responsabLes du 
cancer, de faciLiter Les programmes de dépistage et de traite­
ment, d'améLiorer La surveiLLance de La santé de groupes spéci­
fiques et L'identification de facteurs de risque de cancer et 
enfin de coLLaborer avec des organismes internationaux et 
nationaux en vue de La réaLisation de ces objectifs et de 
L'appLication des résuLtats de La recherche sur Le cancer.
L'information et L'éducation du pubLic et des professions con­
cernées ont incontestablement un rôle important à jouer dans la 
prévention du cancer et dans Les thérapeutiques appliquées en La 
matière. C'est pourquoi Le projet de résoLution suggère qu'on 
Leur accorde toute L'importance qu'elLes méritent. La Commission 
s'efforcera d'agir conjointement avec Les autorités nationales.
Cette proposition est en cours de discussion du ConseiL.
5. S'agissant de La recherche, différentes actions se rapportant à 
La cancérogénèse et aux thérapeutiques du cancer ont bénéficié 
d'une aide financière dans Le cadre de programmes de recherche 
de La Communauté, à savoir principalement Les programmes de La 
CEE et de La CECA relatifs à La protection de L'environnement, à 
La protection contre Les rayonnements et à La recherche 
médicale. C'est dans ce cadre qu'une aide financière a été

apportée au centre de coordination et d'information de 
l'Organisation européenne de recherche pour le traitement du 
cancer (European Organization for Research on Treatment of 
Cancer, ou EORTC).
6. La Commission a fait savoir au Conseil que, conformément aux 
décisions du sommet de Milan, une action de coordination 
"cancer" (1) sera incluse dans la proposition visant à renouve­
ler son programme de recherche médicale, qui doit être présenté 
au Conseil début 1986. Ce programme définit clairement une 
action "cancer" qui portera sur les trois domaines suivants :  
dépistage et diagnostic, traitements faisant appel à différentes 
modalités (y compris la mise au point et le perfectionnement 
d'essais cliniques dans le cadre de projets consacrés à des 
organes spécifiques) et transfert des résultats de la recherche. 
Pour l'exécution de ce programme, la Commission s'efforcera 
d'utiliser au maximum les structures existantes.
CONCLUSIONS
7. Tant sur le plan national qu'international, d'importants efforts 
sont actuellement consentis. Les actions communautaires en la 
matière ont été décrites plus haut. De nouvelles initiatives ont 
été proposées aux derniers Conseils européens. Etant donné que 
des consultations et une coordination appropriées sont souhai­
tables entre toutes les parties concernées, il semble que le 
cadre communautaire se prête au développement d'une action co­
hérente sur le thème de "l'Europe contre Le cancer", susceptible 
de maximaliser les résultats des différents efforts déjà con­
sentis sans pour autant gêner le fonctionnement des travaux en 
cours et sans créer non plus de double emploi.
La Commission prévoit dans un premier temps de créer un comité 
d'experts ad hoc composé de scientifiques et de cancérologues de 
haut niveau et chargé de formuler des recommandations sur les 
moyens propres à mettre en oeuvre une action européenne contre 
le cancer.
(T ) COM(85)530 final.

LE CONSEIL EST DONC INVITE
■  a décider Le lancement d'une action dénommée "l'Europe contre le 
cancer", destinée à assurer la coordination optimale de toutes 
les initiatives prises actuellement en Europe ainsi que l’étude 
de nouvelles initiatives dans les domaines de la prévention et de 
la recherche (y compris les thérapeutiques);
à prendre acte de l'intention de la Commission de créer le comité 
d'experts mentionné plus haut et de faire rapport au Conseil 
d'ici trois mois, sous forme de propositions spécifiques fondées 
sur les recommandations de ce comité;
à s'engager à examiner en priorité les propositions existantes de 
la Commission en matière de prévention ainsi que ses propositions 
futures en matière de recherche, de façon à permettre leur 
adoption rapide. -------  -------. · ·....-
_d
_e...travail, voir pièce jointe a la version anglaise du document SEC(85)1877. ------------ ----

COMMISSION  
OF THE
EUROPEAN COMMUNITIES
DIRECTORATE-GENERAL  
FOR EMPLOYMENT. SOCIAL AFFAIRS  
AND EDUCATION■  Brussels·· 21 November 4985·
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 BrusselsTelephone:
Telephone exchange: 235 11 1 1  
Direct line: 235....Telex:
COMEU B 21877Telegraphic address:  
COMEUR Brussels

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.

INTERNAL MARKET
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.
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.

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 substances 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
7.1. 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.
7.2. 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.

8.0. PUBLIC HEALTH
8.1. A number of pi Lot 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.
\
!
Î

9.0.STATISTICS
9.1. The 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- 
dependent environment was the subject of a report on "The Confidentiality 
of Medical Records" presented in 1984.

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 expo'sures 
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.
10.4. 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 
Decisions.
!

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.
7. Directive 84/466/Euratom - 3.9.1984, laying down basic 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
Communi ty 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. 0.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.
Publi cations
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 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·
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'is.sion 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.
4. 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 programme of the European Sconomic
Community for a consumer protection and information policy.
O.J. C 133 of 3.6.1981.
7. Resolution.  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 practice 
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 j
the effects on the health of workers of physical and other environmental i  
factors at the workplace - O.J. C.307 - 27.11.1981. I
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. 8 D. programme in the
field of environment (1981-1985) - O.J. I _101 - 11.4.1981.