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Prior Authorisation Schemes: Trade Barriers in Need of Scientific Justification
Published online by Cambridge University Press: 20 January 2017
Abstract
Case C-333/08 Commission v. French Republic ‘processing aids’ [2010] ECR-0000
French prior authorisation scheme for processing aids in food production infringes upon Article 34 TFEU
1. A prior authorisation scheme not complying with the principle of proportionality, infringes upon Article 34 TFEU.
2. A correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for health, and, secondly, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research.
3. A Member State cannot justify a systematic and untargeted prior authorisation scheme by pleading the impossibility of carrying out more exhaustive prior examinations by reason of the considerable quantity of products which may be used or by reason of the fact that manufacturing processes are constantly changing. (author's headnotes)
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References
1 Judgment of 28 January 2010.
** Editorial Hint: Art. 34 TFEU; Art. 6 and 7 Regulation 178/2002.
2 To this effect see Article 1(2) GFL.
3 The European Food Safety Authority (EFSA); footnote added.
4 According to the European Commission this reversal of the burden of proof is based on the precautionary principle. See its Communication on the Precautionary Principle (2.2.2000 COM(2000) 1 final).
5 ECJ 23 September 2003, Case C-192/01, ECR 2003, I-09693.
6 ECJ 5 February 2004, Case C-95/01, ECR 2004 I-01333.
7 ECJ 2 December 2004, Case C-41/02, ECR 2004 I-11375.
8 Article 6 GFL refers to “other legitimate factors” to be taken into account. In the context of Art. 36 TFEU (the former Article 30 EC) probably only those factors are “legitimate” that fit within the categories given in that provision (i.e., the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property).
9 “(b) ‘processing aid’ shall mean any substance which:
(i) is not consumed as a food by itself;
(ii) is intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing; and
(iii) may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product[.]”
10 Fortification is an exception in the sense that it mainly consists of adding known vitamins and minerals in increased quantifies to certain foods.
11 Article 14 and 17(1) GFL.
12 “A … systematic and untargeted prior authorisation scheme …, [a]s is apparent from Articles 6 and 7 of Regulation No 178/2002, concerning the analysis of risks and the application of the precautionary principle, … does not correspond to the requirements laid down by the Community legislature as regards both Community and national food legislation and designed to achieve the general objective of a high level of health protection” (Section 103).
13 Alternatively, if the interpretation the ECJ gives of the principles of EU food law is so completely at odds with the application by the legislature, one might wonder how probable that interpretation is.
14 Or conform to international standards such as the Codex Alimentarius – which is also based on risk analysis.
15 Complaints were lodged by the USA, Canada and Argentina, supported by Australia, Brazil, Chile, China, Chinese Taipei, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand and Uruguay.
16 Decision available on the Internet at <http://www.wto.org/english/news_e/news06_e/291r_e.htm>.
17 Available on the Internet at <http://www.ipfsaph.org/cds_upload/kopool_data/WTOSPSDOC_0/en_gen713.doc>.
18 Available on the Internet at <http://r0.unctad.org/biotrade/BTFP/BTFP-docs/EU_NF_Peru_WTO_EU_Response_G_SPS_Gen_699_en.PDF>.
19 Emphasis in original.
20 Bernd M.J. van der Meulen, Reconciling Food Law to Competitiveness. Report on the Regulatory Environment of the European Food and Dairy Sector (Wageningen Academic Publishers 2009), available on the Internet at <http://www.wageningenacademic.com/reconciling>.