1. EU Certification Systems Dr. Friedrich Lüdeke, GLOBALG.A.P. Cairo, 12 June 2012

2. © GLOBALG.A.P. Sekretariat | Seite 2 EU Certification Systems CE marking EMAS TOPICS Introduction

3. © GLOBALG.A.P. Sekretariat | Seite 3 I want to export to the EU, what rules apply? HELP ! EU Certification Systems

4. © GLOBALG.A.P. Secretariat | Page 4 Freedom from unacceptable risk of harm DIN EN 45020:1994 Safety State in which the risk of harm (to persons) or damage is limited to an acceptable level DIN EN ISO 8402:1995 EU Certification Systems

5. © GLOBALG.A.P. Sekretariat | Seite 5 EU Certification Systems

6. © GLOBALG.A.P. Sekretariat | Seite 6 EU Certification Systems CE marking EMAS TOPICS Introduction

7. © GLOBALG.A.P. Sekretariat | Seite 7 The CE marking as it has been legally called since 1993 (per directive 93/68/EEC)(DECISION No 768/2008/EC) is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives. EU Certification Systems

8. © GLOBALG.A.P. Sekretariat | Seite 8 CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries) CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities. EU Certification Systems

9. © GLOBALG.A.P. Sekretariat | Seite 9 EU Certification Systems

10. © GLOBALG.A.P. Sekretariat | Seite 10 There are certain rules underlying the procedure to affix the marking: Products subject to certain EC directives providing for CE marking have to be affixed with the CE marking before they can be placed on the market. Manufacturers have to check, on their sole responsibility, which EU directives they need to apply for their products. The product may be placed on the market only if it complies with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly. The manufacturer draws up an EC declaration of conformity and affixes the CE marking on the product. If stipulated in the directive(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure. If the CE marking is affixed on a product, it can bear additional markings only if they are of different significance, do not overlap with the CE marking and are not confusing and do not impair the legibility and visibility of the CE marking. EU Certification Systems

11. © GLOBALG.A.P. Sekretariat | Seite 11 EU Certification Systems Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements. If a product has minimal risk, it can be self-certified where manufacturers a Declaration of Conformity and affixes the CE marking to their own product. Manufacturer then must do several things: Decide whether the product needs to have a CE marking and if the product applies to more than one directive it needs to comply with all of them. Choose the conformity assessment procedure from the modules called out by the directive for the product

12. © GLOBALG.A.P. Sekretariat | Seite 12 EU Certification Systems CE marking EMAS TOPICS Introduction

13. © GLOBALG.A.P. Sekretariat | Seite 13 EU Certification Systems

14. © GLOBALG.A.P. Sekretariat | Seite 14 EU Certification Systems What is EMAS? The EU Eco-Management and Audit Scheme (EMAS) is a management tool for companies and other organisations to evaluate, report and improve their environmental performance. The scheme has been available for participation by companies since 1995 and was originally restricted to companies in industrial sectors. Since 2001 EMAS has been open to all economic sectors including public and private services. In 2009 the EMAS Regulation was revised and modified for the second time. Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) was published on 22 December 2009 and entered into force on 11 January 2010.

15. Questions - Discussion - Contact Dr. Friedrich Lüdeke E-Mail: luedeke@globalgap.org Fon: +49 (0) 50 22 89 102 97 www.globalgap.org THANK YOU FOR YOUR ATTENTION! © GLOBALG.A.P. Sekretariat | Seite 15