Article contents
Increasing Legal Certainty without Trust: Why Regulation 2019/515 Cannot Achieve the Unachievable
Published online by Cambridge University Press: 14 July 2020
Abstract
More than 40 years after Cassis de Dijon, the mutual recognition in the field of goods is still a failure. The promise of this principle for ensuring both market access and regulatory diversity has not been kept. Therefore, today, businesses rarely rely on mutual recognition to sell their products in another Member State. In an attempt to stimulate this procedure further, the European Union legislator tried to simplify the procedures to be followed by businesses and public administrations through Regulation 2019/515. This article argues that, although the Regulation creates more legal certainty, it fundamentally fails to address the underlying problem of lack of trust that has stalled mutual recognition in the past.
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- European Journal of Risk Regulation , Volume 12 , Special Issue 1: Special Issue on COVID-19 and Soft Law , March 2021 , pp. 196 - 211
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- © The Author(s), 2020. Published by Cambridge University Press
Footnotes
I want to thank Professor Van Cleynenbreugel, Professor Griffith and A Carter for reviewing and discussing earlier drafts of this paper.
References
1 For a detailed review on this topic, see M Maduro, “So close and yet so far: the paradoxes of mutual recognition” (2007) 14 Journal of European Public Policy 814; SK Schmidt, “Mutual recognition as a new mode of governance” (2007) 14 Journal of European Public Policy 667; C Janssens, The Principle of Mutual Recognition in EU Law (5th edn, Oxford, Oxford University Press 2013); K Nicolaïdis, “Trusting the Poles? Constructing Europe through mutual recognition” (2007) 14 Journal of European Public Policy 682.
2 European Commission, Impact Assessment Accompanying the Document Proposal for a Regulation of the European Parliament and of the Council on the Mutual Recognition on Goods Lawfully Marketed in Another Member State (SWD 2017 471) 5.
3 European Commission, The Single Market in a Changing World (COM 2018, 772)Google Scholar.
4 European Commission, Technical Harmonisation and Standards: A New Approach (1985, P/85/12).
5 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation [2012] OJ L316.
6 European Commission, Analysis of the Implementation of the Regulation (EU) No 1025/2012 from 2013 to 2015 and Factsheets (COM 2016, 212 final) 23–25.
7 “Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States”.
8 “The provisions of Articles 34 and 35 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; 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. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States”.
9 Case 120/78 Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein (Cassis de Dijon) [1979] ECLI:EU:C:1979:42, para 14.
10 Case 302/86 Commission v. Denmark [1988] ECLI:EU:C:1988:421.
11 Case 120/78 Cassis de Dijon [1979] ECLI:EU:C:1979:42.
12 Joined Cases C-267/91 Criminal Proceedings Against Bernard Keck and Daniel Mithouard [1993] ECLI:EU:C:1993:905, para 15.
13 “Around 87% of the enterprises operating within the non-harmonised sectors are micro enterprises (i.e. with less than 9 employees) and around 11% are small and medium enterprises (i.e. with a number of employees between 50 and 250)”. European Commission, supra, note 2, 12.
14 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (codification) [2015] OJ L241.
15 Art 5 of Directive 2015/1535.
16 Art 34 TFEU.
17 European Commission, Study on the Costs and Benefits of the Revision of the Mutual Recognition Regulation (EC) No 764/2008 (2017) 33.
18 European Commission, REFIT Evaluation Accompanying the Document Proposal for a Regulation of the European Parliament and of the Council on the Mutual Recognition on Goods Lawfully Marketed in Another Member State (SWD 2017, 475 final) 24.
19 “Since the New Approach calls for common essential requirements to be made mandatory by legislation, this approach is appropriate only where it is possible to distinguish between essential requirements and technical specifications. Further, as the scope of such legislation is risk-related, the wide range of products covered has to be sufficiently homogeneous for common essential requirements to be applicable. The product area or hazards also have to be suitable for standardisation”. European Commission, The “Blue Guide” on the Implementation of EU Products Rules 2016 [2016] OJ C272.
20 European Commission, supra, note 17, 63.
21 European Commission, supra, note 2, 45.
22 European Commission, supra, note 18, 67.
23 idem.
24 European Commission, supra, note 18, 67.
25 ibid, 176.
26 Maduro, supra, note 1, p 815.
27 idem.
28 idem.
29 Schmidt, supra, note 1, p 672.
30 idem.
31 C Barnard, The Substantive Law of the EU: The Four Freedoms (5th edn, Oxford, Oxford University Press 2016) p 150.
32 ibid, 172.
33 European Commission, supra, note 18, 7.
34 ibid, 81.
35 European Commission, supra, note 17, 56; European Commission, supra, note 18, 177.
36 “As regards businesses, the main costs incurred are triggered by the need to adapt the products to the applicable national rules, when mutual recognition is either denied or not used for penetrating the market. These costs are estimated on average at 23 000 Euro per product and per market. High costs are also related to delays in entering a market, estimated at 115 000 Euro per product and per market, and to lost opportunities, when businesses relinquish entering a market because of different national rules that require their products to be adapted. On average, the latest are estimated at 136 000 Euro per product and per market. The costs related to challenging administrative decisions denying market access are considered as less important, mainly because few economic operators choose to do so. The estimates are around 32 000 Euro per product and per market. There are however considerable variations in the answers”. European Commission, supra, note 2, 74–75.
37 European Parliament, Briefing Document: Mutual Recognition of Goods, European Parliamentary Research Service (2019) 4–5.
38 European Commission, The Goods Package: Reinforcing Trust in the Single Market (COM 2017, 787 final).
39 ibid, 7.
40 European Commission, Upgrading the Single Market: More Opportunities for People and Business (COM 2015, 550 final).
41 European Commission, supra, note 2, 31.
42 “During the 2016 public consultation, 84% of Member States, 85% of businesses and 82% of citizens supported this option”. European Commission, supra, note 2, 37.
43 Art 2 Regulation (EC) 764/2008.
44 Art 2(2)(a) Regulation (EU) 2019/515.
45 “A prior authorisation procedure is an administrative procedure established by the legislation of a Member State in accordance with which, before a product may be placed on that Member State’s market, the competent authority of that Member State must give formal approval following an application”. European Commission, supra, note 18, 166.
46 <https://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/products-list_en> (last accessed 20 May 2020).
47 Art 12(4) Regulation (EC) 764/2008.
48 “In 2015, for example, the web-page hosting the product list received 2655 visits, and 59% of them left the page immediately, without trying to use the list”. European Commission, supra, note 18, 35.
49 Recital (12) of Regulation (EU) 2019/515: “In order to help to identify which types of goods are subject to this Regulation, the Commission should assess the feasibility and benefits of further developing an indicative product list for mutual recognition”.
50 European Commission, supra, note 18, 62.
51 European Commission, supra, note 2, 137.
52 European Commission, supra, note 38, 8.
53 European Commission, supra, note 2, 37–38.
54 Eg Directive 2009/48/EC on the safety of toys [2009] OJ L170.
55 Art 4(1) al.1er Regulation (EU) 2019/515.
56 Art 4(1) al.3 Regulation (EU) 2019/515.
57 Art 4(1) al.6 Regulation (EU) 2019/515.
58 Art 4(1) al.4 and Recital 18 Regulation (EU) 2019/515.
59 Art 4(2) Regulation (EU) 2019/515.
60 Art 4(3) Regulation (EU) 2019/515.
61 Art 4(5) Regulation (EU) 2019/515.
62 European Commission, supra, note 2, 37–38.
63 European Commission, supra, note 18, 128.
64 “On the contrary, a mandatory Declaration of Compliance in the non-harmonised area would be an administrative burden for economic operators, as economic operators would have to draft it and present it no matter what, even for simple products where there are no (or few) applicable national rules and therefore no real need for such a declaration and no real added value in terms of facilitating dialogue and market access”.
European Commission, supra, note 2, 49.
65 “More than a third of the product contact points assess that among SMEs seeking to market a product in another Member State, less than 25% know and understand the mutual recognition principle, while 40% of product contact points believe that only between 25% and 50% of SMEs know and understand the principle”. European Commission, supra, note 18, 142–43.
66 European Commission, supra, note 2, 12.
67 European Commission, supra, note 18, 192.
68 The Product Contact Point is the contact for the economic operator for questions pertaining to the application of the mutual recognition principle. Each EU Member State is required to establish a Product Contact Point. Through information on national rules and remedies, the Product Contact Points help reduce the risk that a product is unlawfully denied access to the market of another EU Member State.
69 European Commission, supra, note 18, 157–59.
70 European Commission, supra, note 2, 142–43.
71 Art 5(3) Regulation (EU) 2019/515.
72 European Commission, supra, note 18.
73 Commission Proposal for a Regulation of the European Parliament and of the Council laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 (COM 2016, 157).
74 European Commission, supra, note 18, 115.
75 ibid, 114.
76 Art 5(1) Regulation (EU) 2019/515.
77 Art 5(2) Regulation (EU) 2019/515.
78 Art 5(3) Regulation (EU) 2019/515.
79 Art 5(6) Regulation (EU) 2019/515.
80 Arts 5(4) and (5) Regulation (EU) 2019/515.
81 Art 5(8) Regulation (EU) 2019/515.
82 Arts 5(10) and (11) Regulation (EU) 2019/515.
83 Art 5(12) Regulation (EU) 2019/515.
84 National technical rules are sometimes given effect in a Member State by means of a prior authorisation procedure, under which formal approval has to be obtained from a competent authority before the goods can be placed on the market there.
85 European Commission, supra, note 18, 168.
86 ibid, 166.
87 Art 6(1) Regulation (EU) 2019/515.
88 Eg C-672/15 Procureur de la République v Noria Distribution SARL (2017) ECLI:EU:C:2017:310, para 49; Case C-320/03 Commission v. Austria (heavy lorries) [2005] ECLI:EU:C:2005:684.
89 See in the food supplements sector: Case C-672/15 Procureur de la République v Noria Distribution SARL [2017] ECLI:EU:C:2017:310. See also B Jan, “Mutual recognition failure in the light of free movement of food supplements: Judgement of the CJEU, 27 April 2017, Noria Distribution SARL” (2018) 45(3) Legal Issues of Economic Integration 311.
90 “In the period between the entry into force of the Regulation 764/2008 on 13 May 2009 and today, the Commission has received 3918 notifications. All notifications received come from 6 Member States, and one Member State, namely Portugal, accounts for around 80% of the notifications received”. European Commission, supra, note 18, 35.
91 Case C-194/94 CIA Security International SA v Signalson SA and Securitel SPRL (1996) ECLI:EU:C:1996:172.
92 Eg fertilizers, food labelling, food supplements, construction products and hallmarks. European Commission, supra, note 18, 23.
93 ibid, 187.
94 Eg Case C-95/01 Greenham and Abel (2004) ECLI:EU:C:2004:71.
95 Art 5(4)(a) Regulation (EU) 2019/515.
96 Arts 5(10) and (11) Regulation (EU) 2019/515.
97 European Commission, supra, note 18, 35–37.
98 European Commission, Guidance Document: “The Concept of ‘Lawfully Marketed’ in the Mutual Recognition Regulation (EC) No 764/2008 (COM 2013, 592 final).
99 European Commission, supra, note 18, 52.
100 idem.
101 SOLVIT is a service provided by the national administration in each Member State that aims to find solutions for individuals and businesses when their rights have been breached by public authorities in another Member State. The principles governing the functioning of SOLVIT are set out in Commission Recommendation 2013/461/EU, according to which each Member State is to provide for a SOLVIT Centre that has adequate human and financial resources to ensure that the SOLVIT Centre takes part in SOLVIT.
102 Art 8 Regulation (EU) 2019/515.
103 Art 8 para 1 Regulation (EU) 2019/515.
104 Art 8 para 4 Regulation (EU) 2019/515.
105 “When asked to rank obstacles to mutual recognition by order of importance, the difficulty in challenging administrative decisions denying or restricting market access was considered as the main obstacle by businesses (62% of businesses responding to the 2016 public consultation), and 72% considered that ensuring effective remedies for taking action against such decisions should constitute the Commission’s main priority”. European Commission, supra, note 2, 23.
106 “Adaptation costs were estimated between 1000 and 150 000 Euro per product and per market. Delays for entering a market were estimated between 3000 and 500 000 Euro per product and per market, and lost opportunities, were estimated between 10 000 and 500 000 Euro per product and per market”. European Commission, supra, note 18, 45–46.
107 European Commission, supra, note 2, 39.
108 ibid, 50.
109 ibid, 22.
110 ibid, 30.
111 Maduro, supra, note 2, 822.
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