Opinion of the Advocate General — ECLI:EU:C:2000:196
Date: 2000-04-06
Language of the case: French
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Free movement of goods;Measures having equivalent effect;Quantitative restrictions
Procedure: Action for failure to fulfil obligations - successful;Action for failure to fulfil obligations - unfounded
Origin: France

Summary of the Judgment 
1. Free movement of goods — Derogations — Protection of public health — Prior 
registration procedure for reagents — Whether permissible — Conditions 
(EC Treaty, Art. 36 (now, after amendment, Art. 30 EC» 
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SUMMARY — CASE C-55/99 
2. Actions for failure to fulfil obligations — Proof of failure to fulfil obligations — 
Burden of proof on the Commission 
(EC Treaty, Art. 169 (now Art. 226 EC)) 
3. Free movement of goods — Quantitative restrictions — Measures having equivalent 
effect — Obligation to state a registration number on the external packaging of 
medical reagents and to mention that registration on the accompanying notice — Not 
permissible — justification — Protection of public health — None 
(EC Treaty, Arts 30 and 36 (now, after amendment, Arts 28 EC and 30 EC)) 
1. In the absence of harmonising rules it is 
for the Member States to decide on 
their intended level of protection of 
human health and life and on whether 
to require prior authorisation for the 
marketing of products liable to create a 
danger to health. The Member States 
are therefore authorised in principle to 
introduce a prior registration pro­
cedure, which will by its nature be less 
strict than prior authorisation before 
placing on the market, for reagents 
which, while presenting no danger 
themselves, are liable, if only indirectly, 
to expose the health or life of humans 
to danger if their diagnostic perfor­
mance is not reliable. Nevertheless, the 
principle of proportionality requires 
that the power of the Member States 
to impose restrictions in trade in pro­
ducts from other Member States should 
be limited to what is necessary to attain 
the objectives of protection being legiti­
mately pursued. 
(see paras 27-29) 
2. In proceedings under Article 169 of the 
Treaty (now Article 226 EC) for failure 
to fulfil an obligation, it is for the 
Commission to prove the allegation 
that the obligation has not been ful­
filled and to place before the Court the 
information needed to enable it to 
determine whether the obligation has 
not been fulfilled. 
(see para. 30) 
3. A Member State fails to fulfil its 
obligations under Article 30 of the 
Treaty (now, after amendment, Art­
icle 28 EC) if it imposes, in national 
legislation on medical reagents, the 
obligation to state on the external 
packaging the national registration 
number allocated following registra­
tion of the reagent and to mention that 
registration on the notice accompany­
ing each reagent. 
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COMMISSION V FRANCE 
Mentioning the registration merely 
guarantees the user that the reagent 
has been registered with the competent 
authorities, and does not provide any 
additional information which might 
effectively protect public health. By 
contrast, the other requirements of the 
legislation, namely that the name and 
address of the distributor and the batch 
number of manufacture must appear 
on both the external packaging and the 
primary packaging of the reagent itself, 
while the name and address of the 
manufacturer, distributor and, if any, 
the importer must appear on the 
accompanying notice, constitute mea­
sures which are sufficient to ensure that 
reagents are traceable. In view of the 
existence of less restrictive means, such 
an obligation does not therefore com­
ply with the principle of proportional­
ity. 
(see paras 43, 45-46 and operative part 1) 
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