COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 19.03.1998 
COM(1998) 188 final - COD 169 
OPINION OF THE COMMISSION 
pursuant to Article 189 b (2) (d) of the EC Treaty, 
on the European Parliament's amendments 
to the common positions adopted by the Council on: 
the proposal for a European Parliament and Council Directive on the 
approximation of the laws of the Member States concerning foods and food 
ingredients treated with ionising radiation; and 
the proposal for a European Parliament and Council Directive on the 
establishment of a Community list of foods and food ingredients treated with 
ionising radiation. 
AMENDING THE PROPOSAL OF THE COMMISSION 
pursuant to Article 189 a (2) of the EC Treaty 

EXPLANATORY MEMORANDUM 
1. BACKGROUND 
The objectives of these proposals, based on Article 100a, are: 
- to lay down the rules to be observed by irradiation units (standards, inspections, 
records, radiation sources, etc.); 
- to define the conditions for authorising foodstuff irradiation (purposes, 
wholesomeness of food, reasonable need for treatment); 
- to establish procedures for authorisation of treatment with ionising radiation and the 
marketing and import of foods treated (doses and sources of radiation, inspections, 
labelling, etc.) and 
- to establish a Community list of foods authorised for such treatment. 
The Commission submitted its proposal to the Council on 9 December 1988. 
The ESC gave its opinion on 31 May 1989. 
On first reading (10 October 1989) Parliament proposed banning the treatment for ten of 
the eleven product categories proposed by the Commission and accepted it for dried 
aromatic herbs, spices and vegetable seasonings only. 
Amongst other changes, the amended Commission proposal (COM(89)576 final - SYN 
169) limited the number of categories of foodstuff authorised for irradiation treatment to 
eight. It restricted irradiation to cases where there were clear benefits for controlling 
pathogenic microorganisms in food (public health) and insects harmful to dried fruit and 
vegetables. 
The common position was adopted on 27 October 1997 and consisted of two texts since, 
in 1992, the Council had split the Commission proposal into two parts: 
- the framework Directive on the general and technical aspects which broadly satisfied 
Parliament on labelling and decisions to authorise products; and 
- the implementing Directive on the list of foods treated. 
This list contained only a single category of foodstuff authorised for irradiation 
treatment - dried aromatic herbs, spices and vegetable seasonings,, as proposed by 
Parliament. 
The Commission accepted these texts, even though they only partly met the objectives of 
its 1988 proposal. 
Five of the amendments proposed by Parliament on first reading were included in the 
Commission's amended proposal and two of them were finally incorporated in the 
Council's common position, which, in turn, restored six of Parliament's amendments 
which had been rejected by the Commission. 
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2. EUROPEAN PARLIAMENTS POSITION 
On second reading (17 February 1998) Parliament's Committee on the Environment, 
Public Health and Consumer Protection proposed 25 amendments, three of which were to 
the implementing Directive. Eight more were submitted subsequently but considered 
inadmissible. 
The plenary session adopted just 14 amendments, three of them to the implementing 
Directive, aiming at: 
- clarifying the text and making it more specific (amendments 1, 2, 7, 11 (first part), 12 
and 23 (first part)); 
- involving Parliament, even in the arrangements for consultation of the Scientific 
Committee for Food (amendments 6 and 18); 
- imposing in the legislation purely technical requirements, e.g. specific analytical test 
procedures for detection of food treated with ionising radiation (amendments 9, 11 
(second part) and, in the implementing Directive, 23 (second part), 24 and 25); 
- removing the possibility for the Commission to take decisions in the light of safeguard 
measures adopted by the Member States (amendments 8 and 19); 
- halving the grace period for prohibition of irradiated foodstuffs not complying with 
the Directive (amendment 20). 
3. COMMISSION OPINION 
(a) The Commission can accept: 
- Amendment 1, because it reflects consumers' concerns more closely; 
- Amendments 2,11 (first part), 12 and 23 (first part) which clarify the text and define it 
more closely; 
- Amendment 7 which adds to the recital reasons substantiating Annex I. 
For these reasons, as provided for by Article 189a of the EC Treaty, the Commission has 
decided to amend its proposal to incorporate these amendments. 
(b) By contrast, the Commission cannot accept: 
- Amendments 6 and 18 imposing an obligation for Parliament to be involved in the 
arrangements concerning the Commission's obligation to consult the Scientific 
Committee. 
The obligation to consult the Scientific Committee must not be confused with the 
procedure for adoption of provisions for which Parliament is responsible together with 
the Council. This amendment is unnecessary, given that the Directive is based on 
Article 100a of the Treaty. 
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Amendments 8 and 19 concerning the Commission's powers in response to safeguard 
measures. 
Amendments to the Directive in response to safeguard measures must be adopted as 
soon as possible to protect public health and to avoid creating obstacles to operation of 
the single market. These objectives could not be met if the regulatory committee 
procedure were replaced by the Article 100a procedure. 
Amendments 9, 24, 25 and the second part of amendments 11 and 23 which impose 
specific analytical test procedures in the legislation. 
The general aspects of inspections are covered by the horizontal Directive on the 
official control of foodstuffs. This imposes no specific analytical methods because it 
is inappropriate to bind legislation to technical performance, which is often overtaken 
by events. Moreover, the follow-up Directive on additional measures concerning the 
official control of foodstuffs places an obligation on accredited laboratories to comply 
with standard EN 45001, which entails use of validated methods. 
Amendment 20, which halves the grace period for prohibition of irradiated foodstuffs 
not complying with the Directive to 12 months. 
Since 18 months are allowed for incorporation of the Directive into national 
legislation, it is completely appropriate to allow at least a further six months before 
prohibiting products not complying. 
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AMENDED PROPOSAL 
for a European Parliament and Council Directive 
on the approximation of the laws of the Member States concerning 
foods and food ingredients treated with ionising radiation 
Common position 
"(4) Whereas in several Member States ... 
consumers can be very concerned about the 
consequences of the use of food 
irradiation;" Amended proposal 
"(4) Whereas in several Member States ... 
consumers may have cause for concern 
about the consequences of the use of food 
irradiation:" 
"(5) Whereas, until the entry into force of "(5) Whereas, until the entry into force of 
the final positive list of foodstuffs ..." the Community positive list of foodstuffs 
"(13) Whereas foodstuffs may only be "(13) Whereas foodstuffs may only be 
treated by the action of ionising radiation if treated by the action of ionising radiation if 
... and if they are wholesome and in a ... and if they are wholesome and in a 
proper condition;" proper condition; since ionising radiation 
cannot be used as a substitute for hygiene 
or health practices or good manufacturing 
or agricultural practice;" 
Aitifiki 
" 1. The list of foodstuffs which may Article 4 
'1. The Community list of foodstuffs 
"3. The Commission shall examine the 
national authorisations in force and, after 
consulting the Scientific Committee for 
Food, submit in accordance with 
Article 100a of the Treaty proposals aiming 
at establishing the list." 
4. ... "3. The Commission shall examine the 
national authorisations in force and, after 
consulting the Scientific Committee for 
Food, submit in accordance with the 
procedure laid down in Article 100a of the 
Treaty proposals aiming at establishing the 
list." 
4. ... 
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AMENDED PROPOSAL 
for a European Parliament and Council Directive 
on the establishment of a Community list of 
foods and food ingredients treated with ionising radiation 
Common position Amended proposal 
Article 1 Article 1 
"1. Without prejudice to the final positive "1. Without prejudice to the Community 
list to be established ..." positive list to be established ..." 
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ISSN 0254-1475 
COM(98) 188 final 
DOCUMENTS 
EN 03 15 10 
Catalogue number : CB-CO-98-195-EN-C 
ISBN 92-78-32522-8 
Office for Official Publications of the European Communities 
L-2985 Luxembourg 
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