2. Enterprise Directorate General European Commission UNECE Workshop on EU Enlargement: Regulatory Convergence in the Non- acceding Countries Athens, Greece, 7-8.11.2003 Evangelos Vardakas, Director Single market, regulatory environment, standardisation and New Approach, Enterprise Directorate-General

3. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 2 Contents 1. Acceding and non-acceding countries 2. Types of regulatory co-operation 3. Types of legislation for industrial products in the EC 4. Regulatory alignment 5. Aims for regulatory convergence 6. PECAs 7. ACAAs 8. Conclusions

4. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 3 1. Acceding and non-acceding countries The present internal market  The present 15 EC Member States and the EFTA countries Iceland, Liechtenstein and Norway (EEA agreement) The countries acceding on 1.5.2004:  Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia The non-acceding country groups:  the remaining three candidate countries: Bulgaria, Romania and Turkey  the Western Balkan countries: Albania, Bosnia- Herzegovina, Croatia, FYROM and Serbia-Montenegro (Stabilisation and Association Agreements) cont.

5. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 4 1. Acceding and non-acceding countries The non-acceding country groups (cont.):  the Euro-Med countries: Algeria, Egypt, Israel, Jordan, Lebanon, Morocco, Palestinian National Authority, Syria, Tunisia (Euro-Mediterranean Association Agreements)  the CIS countries which are former Soviet Union countries (Partnership and Co-operation Agreements)  developed third countries: like Australia, Canada, USA, Switzerland (Mutual Recognition Agreements)  other third countries: like Latin American, Asian and African countries (different types of Foreign Trade Agreements)

6. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 5 2. Types of regulatory co-operation  Exchanging views on each others’ technical regulations, standards and conformity assessment  Discussions pursued in specific sectors to influence each party’s regulatory approach  Traditional MRAs (Mutual Recognition Agreements) without alignment of the relevant technical requirements  Enhanced MRAs based on equivalent or common requirements - based on equivalent rules (similar rules with the same objective) - based on “convergent rules” (same rules) - based on alignment with the community acquis (e.g. Protocols to the Europe Agreement on Conformity Assessment and Acceptance of Industrial products (PECAs))

7. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 6 3. Types of legislation for industrial products in the EC  New and Global Approach directives with pre-market assessment of conformity with the directives and post-market surveillance of compliance by authorities. Possibility to use harmonised voluntary European standards that give presumption of conformity with the essential requirements in the applicable directives.  “Old Approach” directives with detailed technical specifications. Usually control of conformity by public authorities before putting the products on the market.  The voluntary sector Not harmonised, national legislation applies

8. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 7 4. Regulatory alignment  The harmonised New and Old Approach EC legislation is taken over by the Member States. It is practically not possible to negotiate modifications proposed by third countries to it. Any modifications have to be agreed by all EC Member States  The use of equivalent or convergent rules in Agreements may in some special cases be possible but cannot be used as a general approach  Voluntary agreements in the private sector for example between conformity assessment bodies, industries etc. are used when feasible.

9. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 8 5. Aims for regulatory convergence  The candidate countries aim at PECAs and then EU membership (Turkey implements the customs union)  Many Western Balkan countries aim at approximation and implementation of EC legislation, Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAAs) and ultimately EC membership  The Euro-Mediterranean Association Agreements aim, where appropriate, at approximation and implementation of EC legislation and ACAAs  In the Partnership and Co-operation Agreements approximation and implementation of existing and future legislation to that of the EC is foreseen. ACAAs may be considered cont.

10. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 9 5. Aims for regulatory convergence, cont.  The traditional MRAs with developed third countries aim at simplifying the trade between these countries and the EC. As the technical requirements are not aligned between the partners the results of these agreements have not been significant.  The agreements with other third countries aim at understanding the EC regulatory approach and when feasible approximation with and implementation of applicable parts of the EC system

11. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 10 6. PECAs PECA features A PECA applies prior to accession to a specific candidate country and specific product sectors Products in these sectors can move freely in the EC market and in the candidate country provided they fulfil all the EC requirements The sectors are usually New Approach sectors All applicable horizontal and sector legislation has to be transposed and fully implemented by the candidate country All EN standards applying to the sectors have to be adopted Market surveillance must be in operation, when applicable PECAs cease to exist after accession

12. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 11 6. PECAs, cont. PECA agreements are in force with : Czech Republic (CZ) Estonia (EE) Hungary (HU) Latvia (LV) Lithuania (LT) Slovakia (SK) Slovenia (SLO)

13. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 12

14. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 13 6. PECAs, cont. PECA sectors: Electrical safety (CZ, EE, HU, LT, LV, SK, SLO) Electromagnetic compatibility (CZ, EE, HU, LT, LV, SK, SLO) Equipment for use in explosive atmospheres (CZ, SK) Machinery (CZ, HU, LT, SK, SLO) Lifts (CZ, EE, LT) Personal protective equipment (CZ, LT, SK) Gas appliances (CZ, HU, SLO) Simple pressure vessels (CZ, LT) cont.

15. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 14 6. PECAs, cont. PECA sectors, cont.: Pressure equipment (CZ) Medical devices (HU) Active implantable medical devices (HU) Good manufacturing practice for medicinal products (CZ, HU) Good laboratory practice for medicinal products (HU) Construction products (LV) Toys (EE, LV)

16. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 15 7. ACAAs The ACAA is a PECA applied to non candidate neighbouring countries  It guarantees free movement of goods in the EC market and in the ACAA partner country in specific sectors  The conditions like specifying sectors, full transposition and implementation of the applicable EC legislation, full adoption of applicable standards and market surveillance are basically the same as for the PECAs  The ACAA procedures in the EC are presently being developed

17. Evangelos Vardakas, UNECE Workshop, Athens 7-8.11.2003 16 8. Conclusions  The PECAs have been a useful tool for the candidate countries.  It is therefore intended to apply the similar new concept, the ACAA, to suitable neighbouring countries and start with a pilot country in each of the Western Balkan, EURO-MED and CIS areas.  The possibility of having regional ACAAs or using ACAAs for other than neighbouring countries will be investigated when experience from the pilot countries is available