In my last post, I explained how Switzerland, having rejected in a referendum in December 1992 the EEA Agreement which it had signed in May, and having thereupon suspended its membership application to the European Community which it had made in the same month of May 1992, then found an alternative means of participating in the EU/EEA single market. First, it further developed the practice, which it had begun in 1988, of the autonomous adoption of EU law into its own domestic legislation; and second, it successfully negotiated with the EU a series of bilateral agreements, building upon the already extant 1972 Free Trade Agreement, which have given Switzerland a degree of access to the single market almost certainly greater than that of any other state outside the EU/EEA, but without the peril of being obliged (I am discounting here the virtually unusable right of reservation contained in Article 102 of the EEA Agreement) to adopt new EU legislation as it issues forth from the Commission.
How was this achieved, and is it really as good as it sounds? Or is Switzerland in fact forced to adopt the acquis much as the EEA EFTA states are, but with even less influence on the shaping of the legislation with which it then has to comply? In my last post, I looked at the most important of the Bilateral I agreements, that on the Free Movement of Persons, and showed that it was based on ‘the rules applying in the European Community’, but statically as of 2002, and that it has not been updated to conform to the new rules introduced into the EU/EEA by Directive 2004/38/EC, so that there are now significant differences between the Free Movement of Persons regime within the EU/EEA, and the regime that applies for movement between Switzerland and the EU/EEA.
Today I want to lay a foundation for looking at the second of the 7 Bilateral I agreements, that on Technical Barriers to Trade, or more precisely, the ‘Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment‘, also officially described by the European Commission as a Mutual Recognition Agreement which, like the other six of the first set of Bilaterals, was signed in June 1999 and came into force in June 2002. It has been said that:
After tariffs technical barriers to trade for goods and sanitary and phytosanitary (SPS) measures for food and agricultural products are seen as the most immediate barrier and thus typically feature next to tariffs in FTA negotiations. 1
The 1972 FTA reduced tariffs in industrial goods to zero. What remained was to overcome, so far as possible, the barriers to trade caused by differences in product regulations between Switzerland and the European Community. In the worst case, an industrial product would first have to be tested against national regulations in the home country, and then against the regulations of other countries in test facilities in those countries. One way of overcoming this duplication of effort 2 is through Mutual Recognition Agreements, of which three main types may be distinguished. I use the Commission’s terminology for the three types 3:
Here, products are ‘evaluated in the country of production against the regulatory requirements of the other party’. 4 Thus, a product could be tested in the same facility in the home country first for conformity with its national regulations, and then for conformity with the regulations of the other party to the MRA. Central to these agreements are the mutual recognition of these Conformity Assessment Bodies.
The EU has traditional MRAs with the United States, Japan, Canada, Australia and New Zealand. In each case, they concern only a limited number of industrial sectors or product categories, with one Annex to the Agreement for each sector. The MRA with the United States, which entered into force in December 1998, covered six sectors or categories, but of these only two are fully operational, as shown in the table below 5:
With regard to Electrical Safety equipment, the European Commission observes that ‘The Annex (and the EU’s obligations under it) remains suspended because of the position of the [American] Occupational Safety and Health Administration (OSHA)’, which would of course not necessarily be the American perspective on the matter. More generally with regard to the MRAs with the United States and Canada, the Commission comments bluntly that
despite considerable investment on our side, good will is difficult to obtain in cases where there are substantial differences in the regulatory requirements/approach. It has also become apparent that in areas where confidence building has been particularly difficult and implementation of the MRA delayed, the market has found other ways of achieving the same result in a more efficient way. 6
No doubt at least partly as a result of the difficulties experienced, the Commission’s current position is that ‘No further traditional MRAs are foreseen’. 7
[ADDED 2 NOV 2016. It should perhaps be added that while the EU is under no obligation actively to seek further MRAs of this kind, it is ‘encouraged’, under Article 6.3 of the WTO’s Agreement on Technical Barriers to Trade, to be willing to enter into negotiations for the conclusion of such an agreement, at the request of another WTO member.]
Enhanced MRAs with equivalent rules.
Under these agreements, also known as ‘equivalence agreements’ 8 the product regulations of each party are recognised as equivalent to that of the other, so that the product only has to be tested once, in the home country. The Commission explains that:
Equivalence of regulatory requirements can be determined on the basis of adherence to rules or standards developed by a “treaty” organisation (for example, the Conventions of the International Maritime Organisation (IMO)) or where the two parties have agreed, through screening of the relevant legislation, that the respective rules are equivalent.
An example is the ‘Agreement between the European Community and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment’. The Agreement (Article 2(1)):
establishes the conditions under which the importing Party’s Regulatory Authority shall accept the Certificates of Conformity issued by the exporting Party’s Conformity Assessment Bodies in accordance with the technical regulations of the exporting Party, hereinafter referred to as “mutual recognition”.
In the Preamble is noted ‘the shared commitment of the Parties to the work of the International Maritime Organisation (IMO)’, and the Commission states that the Agreement is ‘based on rules of’ the IMO. 9 The Annexes give, for each of 49 types of marine equipment, the international instruments which apply, the relevant EC technical regulations, and the relevant US technical regulations. The regulations for two of these types of equipment are shown below, as examples:
The Agreement appears to be characterised by a full and genuine mutuality, the Parties having equal status, with neither having to conform their regulations to that of the other, but both making their regulations on the basis of the IMO rules.
The MRA between Israel and the EU on Good Laboratory Practice may also be considered to be of this type, based as it is on OECD principles. Article 3(1) reads:
Annex I lists the chemicals covered, and the legislative acts of Israel, and of the EU, which define them, and there appears to be full mutuality and equality in the terms of the Agreement.
Enhanced MRAs with common rules
In this third category are agreements entered into between the EU and states that agree to adopt the acquis communautaire as a basis for their own national legislation in the relevant area. There is then equivalence of legislation, and as with the previous category of Enhanced MRA, this allows for the mutual recognition of CABs, and of the conformity assessment certificates which they issue.
An agreement of this sort, known as a PECA (Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products), was concluded between the EU and several candidate or acceding countries in the period of the Eastern expansion of the Community. 10 They were not self-standing agreements, but Protocols to the Europe Agreements made with those states. As candidate or acceding countries, these states had every inclination to begin to adopt parts of the acquis before the completion of their application or accession process.
The sectors covered by the PECAs varied from country to country. The PECAs with Estonia, Latvia and Lithuania all included electrical safety and electromagnetic compatibility. That with Estonia also included lifts and safety of toys; that with Latvia, toys and construction products; and that with Lithuania, machinery, lifts, personal protective equipment, and simple pressure vessels. 11 Giving an indication of the perceived importance of MRAs to the functioning of the internal market, and the reduction of trade barriers, Elsuwege writes that:
In those specific areas, the PECAs created an enlarged internal market prior to accession. Hence, the Commission regarded the PECAs as “the major instrument of the pre-accession strategy in the field of the free movement of goods”. 12
Taking the PECA with Estonia of March 2003 as an example, Article 1 states the purpose of the Protocol as being to facilitate the elimination of technical barriers to trade, and the means as being ‘the progressive adoption and implementation by Estonia of national law which is equivalent to Community law’:
and in the Annex, for each product sector, are the relevant EU Directives, and Estonian legislation. It can be seen below with regard to Electrical Safety that the Estonian law had been recently updated, and this is true of the other three sectors covered also:
Along very similar lines, a free-standing Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) was concluded with Malta in December 2003, not long before its accession in May 2004. Again, the means to the end of the removal of technical barriers to trade is stated in Article 1 as being the adoption and implementation by Malta of Community law.
The EU Israel ACAA
Another similar agreement, this time not in the context of accession to the EU, was signed with Israel in May 2010, and came into force in January 2013. While still referred to as an ACAA, it is an additional Protocol to the 1995 EU-Israel Association Agreement. The Preamble recognises that:
the adoption and implementation of relevant EU law by Israel provides the opportunity to extend certain benefits of the internal market and to ensure its effective operation in certain sectors,
and considers that, in the sectors covered by the Protocol,
Israel’s national law is substantially aligned with relevant EU law
Articles 1 is similar in structure to that of the PECAs and the Malta ACAA, but expands on the means to be employed to achieve the end of the elimination of technical barriers to trade:
The only sector to be included in the Annex thus far is that to which Pharmaceutical Good Manufacturing Practice (GMP) requirements apply, and the products covered include (p. 1) ‘medicinal products, active pharmaceutical ingredients, pharmaceutical excipients or mixtures thereof, for human or veterinary use.’ Certain medicinal products, including those derived from human blood or human plasma, are excluded, but for some of these, including the two mentioned, there is provision to include them at a later date.
It can be seen from Article 1(2)(a) that Israel is obliged under the Agreement to adopt and implement regulations, standards and procedures equivalent to those of the EU. As a non-member it does not of course have any say in decision-making in the EU and so, on the face of it, is in the invidious position of having to follow laws made by others. However, the situation for this particular sector may not be as bad as it first appears, for two reasons.
First, in Section IV.10, headed ‘Information and Cooperation’, of the Annex to the Agreement, Israel is allowed to participate in discussions of GMP coordinated by the European Medicines Agency (EMA) of the European Union; in the network of Official Medicines Control Laboratories coordinated by the Directorate for the Quality of Medicines and Healthcare (EDQM), which is a Directorate not of the EU but of the Council of Europe; and in the Community database (EudraGMDP) on GMP managed by the EMA. 13 Through this close involvement with their counterparts in Europe (not just in the EU), Israeli technical experts will no doubt have opportunity to contribute to the further development of the legislative framework for GMP, to which it will be obliged to conform.
Second, in this sector of pharmaceutical GMP, there is a high level of international harmonisation, achieved mainly through the activities of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). As a result, the GMP Guidelines of the WHO, which has Observer status in the ICH, and of which Israel is a member, are virtually identical to the GMP Guidelines of the EU. For example, the WHO GMPs for sterile pharmaceutical products begins with the following General Considerations:
which differs significantly in two words only (‘the required’ rather than ‘an appropriate’) from the corresponding EU Guidelines on the Manufacture of Sterile Medicinal Products:
A ‘Comparison of EU GMP guidelines with WHO guidelines‘ by Dr. Dirk Feldman and Prof. Dr. Hans-Jörg Müller concluded (p. 45) that ‘When comparing WHO and European GMP requirements, it can be stated that both guidelines have been quite clearly aligned in the last few years.’ Again, Part II of the EU GMP Guidelines, entitled ‘Basic Requirements for Active Substances used as Starting Materials’, of the EU GMP Guidelines, is based on and seems to be almost identical to the GMP Guide for Active Pharmaceutical Ingredients developed by the ICH.
From the practical point of view, therefore, it matters little to Israel that it is obliged to follow the EU GMP Guidelines, since the European, American and Japanese practices have been harmonised through the ICH, leaving Israel no alternative but to follow the same model in one of its virtually identical forms.
From the point of view of national sovereignty, however, there seem to be dangers for Israel in going down this path of conforming national law to EU law, especially since the ACAA allows for further types of industrial product to be incorporated into the Agreement through the addition of sectoral Annexes. I would have preferred to have seen a GMP Mutual Recognition Agreement on the basis of ICH or WHO guidelines, preserving genuine mutuality in the relationship between the EU and Israel.
Commission policy on MRAs
In the most recent policy document on MRAs shown on the relevant page of its web-site, the Commission outlined its strategy and intentions, as of 2004, for seeking further Agreements. Already by that date, it had been concluded (p. 3) that it was ‘not worth pursuing new negotiations’ on traditional MRAs, and that it was enhanced MRAs, whether based on equivalent or on common rules, that were the type ‘worth pursuing in the future’. The Commission then specified the type of MRA it should seek, by country or region.
PECAs should continue to be agreed with candidate countries apart from Turkey, which had no need of one because of its adoption of the acquis for industrial products. For those countries in the Balkans which were participating in the Stabilisation and Association Process, the ‘ultimate objective’ would be the ‘adoption by these countries of the acquis communautaire and EU standards and the negotiation of “enhanced” type MRAs (ACAAs) in certain sectors.’ For Russia, Ukraine, Moldova and the NIS (Newly Independent States of the former Soviet Union), the ‘ultimate objective’ should be the ‘adoption by these countries of EU standards and legislative approach’ (rather than the acquis per se) ‘in key sectors … [so as] to extend the benefits of the internal markets to its neighbours’.
For the Mediterranean region, probably referring especially to those seven nations (Tunisia, Morocco, Israel, Jordan, Egypt, Algeria and Lebanon) with which it had concluded Euro-Mediterranean Association Agreements between 1998 and 2005, the ‘ultimate objective’ was the ‘adoption by these countries of the acquis communautaire and EU standards in key sectors’. It would be necessary to build these countries’ ‘infrastructure and implementation ability in the field of standards and conformity assessment’ before the negotiation of ACAAs could be considered (Israel perhaps being an exception).
Although negotiations were then in progress for a free trade agreement with the Gulf Cooperation Council area, including co-operation on technical regulations, standards and conformity assessment issues, and alignment on international standards, it was considered premature at that stage even to envisage a dialogue which could ultimately lead to MRAs.
For China, the Commission’s objective was the adoption by that country of ‘an open and transparent system of regulation based on international standards.’ As with the Gulf states, there is no mention here of EU standards. The ‘long term objective’ was to ‘to achieve alignment of rules in priority sectors of mutual interest’. The alignment of regulatory requirements ‘would be a prerequisite’ for an MRA.
With regard to ASEAN, international standards are again the ones in view, this time as the ‘overall objective’ of a ‘dialogue on technical regulations, standards and conformity assessment’ that would ‘at the beginning cover exchange of information on regulatory approaches’. The longer term objective should be ‘to promote regulatory equivalence in sectors of mutual trade interest’ leading eventually to the possibility of enhanced MRAs in ‘sectors where there is equivalence of rules and standards’.
The Commission’s policy with regard to the Latin American countries and African, Caribbean and Pacific (ACP) Countries, seems to be ambiguous, whether deliberately or not. On the one hand, it finds it ‘difficult to envisage’ the acceptance of ‘EU standards and rules’ in ‘the near future’ or ‘at this stage’, implying that it could envisage such acceptance in the future. On the other hand, for the ACP countries it sets ‘the conclusion of MRAs based on equivalent rules’ as a long term goal. For the Latin American countries, it sees the possibility of working towards ‘equivalence of rules’ in certain sectors in the ‘medium term’. But then for some ‘priority sectors’ which have already been identified in the context of dialogue with Chile and with MERCOSUR, it can envisage enhanced MRAs based on ‘equivalent/common rules and standards’, bringing into relief the existence of alternative possible approaches, involving the adoption either of EU standards or of international ones.
In conclusion, the Commission’s policy would appear to be, at least as of 2004, to seek MRAs based on the acquis communautaire in neighbouring countries, on international standards in the more developed countries elsewhere in the world, and to reserve the possibility of the future adoption of EU standards and rules in developing countries.
Incorporation in FTAs
A more recent development, not apparently foreseen by the Commission in 2004, has been the incorporation of the mutual recognition of conformity assessment procedures into Free Trade Agreements.
EU-South Korea FTA
Chapter 4 of the EU-South Korea FTA, signed in October 2009, provisionally applied since July 2011, and fully ratified since December 2015, concerns Technical Barriers to Trade. It incorporates the WTO Agreement on Technical Barriers to Trade into the FTA, and draws attention to and affirms certain elements of that WTO Agreement. Notably, the Parties agree (Article 4.4 FTA) to ‘to use relevant international standards as a basis for technical regulations including conformity assessment procedures’ where possible. Article 4.6(1) contains a helpful summary of the different ways in which the results of conformity assessment procedures conducted by one Party may be accepted by the other:
Such mechanisms are put into effect for two industrial sectors through the provisions contained in Annexes to the FTA, one for Electronics and one for Motor Vehicles and Parts. For Electronics (Annex 2-B), the Parties agree to use, where possible, the standards of the ISO, the IEC and the ITU as a basis for their national regulations and their conformity assessment procedures:
For Motor Vehicles and Parts (Annex 2-C), the Parties agree that the UNECE World Forum for the Harmonisation of Vehicle Regulations is the relevant international standard-setting body, and agree to adopt new regulations that issue from that body:
For Electronics, Article 3 of Annex 2-B (p. 1134) lays out the procedures whereby each Party may gain a positive assurance of conformity with its own technical regulations on safety and electromagnetic compatibility (EMC) of products manufactured and tested by the other Party, including among others (Article 3(b)):
Appendix 2-B-2 provides that the EU will accept the simple DoC procedure of Article 3(b)(i), whereas Korea, after a transition period in which it may require certificates from a designated Conformity Assessment Body in the European Union, will choose between the three DoC procedures of Article 3(b)(i)-(iii).
For vehicles, the emphasis in Annex 2-C is on regulatory convergence with UNECE vehicle regulations. Once compliance or harmonisation with UNECE requirements has been attained by a Party, then UNECE approval certificates are considered (Article 8(1) of Annex 2-C) to provide a ‘presumption of conformity’. The importing Party (Article 8(2)) may verify compliance with random sampling.
According to an EU Guide to the Agreement (p. 3):
the EU-South Korea FTA is the first FTA to include specific sectoral disciplines on NTBs to trade.
In its view:
The annexes on NTBs address effectively those regulatory and other barriers that EU industry has identified as being the most important obstacles to access to the Korean market in the sectors concerned.
According to the Guide (p. 3), the acceptance by South Korea of the restriction of conformity assessment procedures to DoCs, after the transition period mentioned above, represents ‘a complete change of the regulatory system for these products in South Korea’, and an acceptance of ‘the European regulatory model’. It does not, however, represent the acceptance of EU regulations. Both Parties maintain their own domestic regulations, and conform them to international rules and standards.
Deep and Comprehensive Free Trade Areas
On 27 June 2014, the EU signed bilateral Agreements with the Ukraine, Moldova and Georgia, bringing into existence Deep and Comprehensive Free Trade Areas (DCFTAs) with these states. These DCFTAs have been all been in provisional operation since 1 January 2016 (the Ukraine DCFTA is not fully ratified because of the rejection by the Dutch people in a referendum held on 6 April 2016 of the EU-Ukraine Association Agreement, of which the DCFTA is a part).
The Ukraine Association Agreement , to examine one in particular, in its Preamble links Ukraine’s economic integration into the EU Internal Market with a process of ‘legislative approximation’:
In case there was any doubt about the direction in which this legislative approximation was to proceed, the Parties also declare themselves:
Article 56, in Chapter 3 on Technical Barriers to Trade, makes it clear that the way in which Ukraine is to ‘gradually achieve conformity with EU technical regulations’ and standardisation, accreditation and conformity assessment procedures, is by incorporating ‘the relevant EU acquis into its legislation’:
The Parties agree to add an ACAA to the Agreement, but only when the relevant Ukrainian legislation, institutions and standards have been ‘fully aligned with those of the EU’:
Then Ukraine will be granted full market access in the sectors covered by the ACAA:
Van der Loo comments 14 that the EU-Ukraine DCFTA is distinguished from ‘all the other EU FTAs by Ukraine’s commitment to:
For Ukraine, the sacrifice of national sovereignty involved in this incorporation of EU legislation, might perhaps be seen as being compensated for by a liberation from an unhealthy dependence on Russia. The EUObserver explains baldly that:
The DCFTA is designed to decouple the Ukrainian economy from Russia and to align it with the EU single market.
According to the same source, Russia was demanding that the Ukraine adopt ‘Russian phytosanitary standards’, in a stark contrast to the DCFTA which, in the next chapter after that on TBTs, aims to approximate Ukraine’s phytosanitary laws to those of the EU:
It may be worth observing simply at this point that the question of the direction in which a nation aligns its technical regulations on industrial and agricultural products is not without political and strategic significance.
An MRA between Canada and the EU was signed in May 1998, and came into force in November that year. It was mainly a traditional MRA, as defined above, with sectoral annexes for Electromagnetic Compatibility, Telecommunications Terminal Equipment (TTI), Electrical Safety, Recreational Craft, and Medical Devices. One further Annex however, concerning pharmaceutical GMP, is based on the mutual recognition of the equivalence of the GMP compliance programs of the Parties.
Article II(2)-(3) states clearly that each Party shall accept the results of the conformity assessment procedures required to demonstrate compliance with their own regulations, produced by conformity assessment bodies of the other Party:
Article II.5 makes clear that the Parties do not necessarily accept each other’s standards or regulations; and that they do not necessarily recognise the equivalence of each other’s standards or regulations, unless this is specified in a sectoral Annex:
Unlike the other Annexes, the Annex on Good Manufacturing Practices is based on ‘the equivalency of their GMP compliance programmes’ as the first article shows (1.1(c)):
In contrast, the end in view in the first sectoral Annex on TTI is the acceptance of certificates of conformity issued in the territory of one Party in accordance with the regulatory requirements of the other Party, with no suggestion of equivalence of regulations:
The relevant regulations for each Party are given in an Appendix to the Annex, and it can be seen that the two regulatory structures differ greatly:
It can be seen that a traditional MRA of this sort does not force changes upon national legislation and require changes to it. It may also be supposed that it is not without its difficulties in practical implementation, requiring as it does the acquisition of expertise by each Party of the regulations and practices of the other.
A Comprehensive Economic and Trade Agreement was signed between Canada and the EU in August 2014, and is awaiting approval and ratification by the Parties. The text is now in a final form after the completion of the legal review process in February 2016.
Chapter 4 of the Treaty concerns Technical Barriers to Trade and incorporates sections of the WTO TBT Agreement. A Protocol on the Mutual Acceptance of the Results of Conformity Assessment commits Canada to (Article 3(1), p. 697):
recognize a conformity assessment body established in the European Union as competent to assess conformity with specific Canadian technical regulations, under conditions no less favourable than those applied for the recognition of conformity assessment bodies established in Canada,
provided that certain conditions are met, and Article 3(2) makes a similar requirement of the EU with respect to Canada.
Annex I (p. 709) lists the sectors that are to be covered initially, and Annex II those that may be included after a consultation that is to be held within three years of CETA coming into force. In addition to all but one of the sectors included in the current MRA are some major categories including machinery, construction products, equipment for use outdoors as it relates to noise emission, toys, measuring instruments, rail systems, gas appliances, personal protection equipment, and equipment placed on board a ship:
Drugs and medicinal products are covered (p. 712-727) by a separate ‘Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products’. The agreement is based on a mutual recognition of the equivalence of the regulatory authorities of the other Party, which are then termed ‘equivalent authorities’. Surprisingly, in a manner reminiscent of arms control regimes, the Parties reserve the right, in exceptional circumstances, to inspect facilities that have been certified as compliant by an equivalent authority of the other Party, thus entering into the territory of the other Party to do so:
No such provision for inspections exists for the other sectors, as would be expected, since each Party is at liberty to examine products imported from the other, and mount a challenge (Article 7, Protocol on the mutual acceptance of the results of conformity assessment, pp. 700-701) to the competence of the relevant conformity assessment body if products do not conform to their technical regulations.
It is noteworthy that while the Commission, as explained above, do not foresee entering into further traditional MRAs, they have in fact agreed to expand the scope of a traditional form of mutual recognition of conformity assessment in CETA, in all the sectors covered except pharmaceutical GMP. Part of the explanation may be that conformity assessment bodies have already been recognised under the existing MRA, and have been functioning (if only now in one sector) in the traditional way, perhaps making it difficult for the Commission to contend for a new approach.
Nevertheless in Article 21(5) CETA (p. 175), in a Chapter entitled Regulatory Cooperation, the Parties agree ‘With a view to enhancing convergence and compatibility between the regulatory measures of the Parties’ to, ‘when appropriate, consider the regulatory measures or initiatives of the other Party on the same or related topics’:
Moreover, in Article 4(4)(1) CETA (pp. 18-19) provision is made to facilitate the development by one Party of a regulation equivalent or similar in scope to one of the other Party, and provision is made in the second paragraph for the mutual recognition of equivalence of corresponding technical regulations of the two Parties:
In Article 4.7(1)(e) the Parties agree that the Committee on Trade in Goods, which will be set up under CETA, and whose remit includes technical barriers to trade (Article 26(2)(1)(a), p. 206), shall:
and it may be that it is through mutual conformity to the standards, regulations and procedures of international bodies or third parties, that equivalence of legislation between the Parties is most likely to be achieved.
I have outlined the three forms of agreement on the mutual recognition of conformity assessment procedures that the EU has made with other nations. With the United States, Japan, Canada (except for GMP), Australia and New Zealand, the MRAs have been of the traditional kind without regulatory convergence.
The US Marine Equipment MRA, the Israel GLP MRA, and the Electronics and Motor Vehicles Annexes of the South Korea FTA, are based on international standards and regulations; and the Canada pharmaceutical GMP agreements in both the MRA and the relevant CETA Protocol are based on equivalency of practice, but without specifying the foundation on which it rests.
The PECAs of the candidate and acceding nations, the Israel GMP ACAA, and the prospective ACAAs in the Ukraine and the other DCFTAs are all based on alignment with EU legislation, or even on the adoption of the relevant EU acquis.
In my next post I intend to examine the Switzerland-EU agreement on mutual recognition in relation to conformity assessment, and in particular to attempt to ascertain whether and to what extent there is genuine mutuality in the agreement, or whether Switzerland is in practice largely obliged to conform its technical regulations to EU regulations.
- S. B. Woolcock, ‘European Trade Policy: the Canada-EU Comprehensive Economic and Trade Agreement (CETA) towards a new generation of FTAs?’, in ‘Europe, Canada and the Comprehensive Economic Partnership Agreement’ (ed. K. Hübner et al; London: Routledge, 2011) p. 32. ↩
- Another way is through a Declaration of Conformity (DoC) by the supplier, who takes responsibility for ensuring that the regulatory requirements are met. See Correia de Brito, A., C. Kauffmann and J. Pelkmans, ‘The contribution of mutual recognition to international regulatory co-operation’, OECD Regulatory Policy Working Papers, No. 2, (Paris: OECD Publishing, 2016) p. 14. Link. ↩
- ‘Priorities for Bilateral/Regional trade related activities in the field of Mutual Recognition Agreements for industrial products and related technical dialogue’, Commission Staff Working Paper, SEC(2004)1072 (Commission of the European Communities, Brussels, 25/08/2004) p. 4-5 ↩
- ‘The “Blue Guide” on the implementation of EU product rules, 2014’, Version 1.1 (European Commission, 15/07/2015) p. 109. Link. ↩
- MRA Newsletter, Edition 9, October 2015, p. 4. Link. ↩
- ‘Priorities’, SEC(2004)1072, p. 4 ↩
- MRA Newsletter, Edition 9, October 2015, p. 4. Link. ↩
- Brito et al, ‘The contribution’, OECD, p. 15. Link. ↩
- ‘Priorities’, SEC(2004)1072, p. 5 ↩
- The Czech Republic, Hungary, Latvia, Lithuania, Slovenia, the Slovak Republic, and Estonia. ‘Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAAs)’, Commission Staff Working Paper, SEC(2004)1071 (Commission of the European Communities, Brussels, 25/08/2014) p. 3. Link. ↩
- P. Elsuwege, ‘From Soviet Republics to EU Member States: A Legal and Political Assessment of the Baltic States’ Accession to the EU’ (Leiden: Nijhoff, 2008) p. 143 ↩
- Elsuwege, ‘From Soviet Republics’, p. 144 ↩
- See also the summary of Israel’s rights under the Agreement on the web-site of the EMA. Link. ↩
- G. Van der Loo, ‘The EU–Ukraine Association Agreement and deep and comprehensive free trade area: a new legal instrument for EU integration without membership’ (Leiden: Hijhoff, 2016) p. 312 ↩