Business seminar on export to Europe

1. Support to the Modernisation of the Mongolia’s Standardisation System (SMMSS) Business seminar on export to Europe Transformation of requirements into opportunities Technical Requirements - Product Safety

2. Product Safety • Legislation to achieve minimum safety protection levels across the EU e.g the General Product Safety Directive 2001/95/EC • Legislation designed to remove or prevent Technical Barriers to Trade across the EU by harmonizing public protection requirements: • “Old Approach” legislation • “New Approach” legislation • Framework legislation that authorises the use of international standards or agreements as the basis of manufacture e.g. much of the EU’s motor vehicle legislation – a kind of “Old Approach” legislation

3. Technical Requirements: The General Product Safety Directive (GPSD) • The GPSD applies if products are not governed by sectoral EU legislation or if that specific legislation is insufficient by itself to protect safety • It imposes a general safety requirement on products placed on the market for consumers or likely to be used by them, including products that provide a service. Its scope includes second-hand products • A safe product is one which poses no threat (or only a reduced threat in accordance with the nature of its use and which maintains a high level of protection)

4. General Product Safety Directive (GPSD): Manufacturer obligations • Manufacturers must put onto the market products which comply with the general safety requirement. In addition they must: • provide consumers with the necessary information in order to assess a product’s inherent threat, particularly when this is not obvious • take the necessary measures to avoid such threats (inform consumers, withdraw products, recall products etc)

5. General Product Safety Directive (GPSD): Distributor obligations • Distributors of products are also obliged to: • supply products that comply with the general safety requirement • monitor the safety of products on the market • provide the necessary documents ensuring that the products can be traced • If manufacturers or distributors discover that a product is dangerous, they must inform the competent authorities and cooperate with them

6. RAPEX • The GPSD also establishes the RAPEX system – the Rapid Exchange of Information • Q - What does this involve? • A - Where EU Member States identify products which pose a serious risk to health & safety, they take rapid intervention measures to protect consumers. They immediately inform the EU Commission via the RAPEX system. This enables other Member States to take rapid action, too. • The EU Commission also has separate powers to implement rapid measures at EU level. • There are separate intervention systems for food, pharmaceutical and medical products

7. Technical Standardisation • “Old Approach” legislation: • Its notable feature is that it contains key technical specifications for public protection within the legislation itself even if it also uses standards as well. This is in contrast to • “New Approach” legislation which in terms of Requirements for public protection, e.g for health & safety, confines itself to goal-setting Essential Requirements legislation, and leaves the technical specifications to meet those requirements to European harmonizing standards

8. Old Approach Legislation • This is used where: • it is public policy still to use it e.g. the food sector • And • by international traditions and/ or agreements which the EU is not in a position to change unilaterally • e.g automobile legislation, or food again

9. The Cosmetics Legislation as an example of Old Approach legislation • The Cosmetics Regulation 1229/2009/EC, replaces the previous Cosmetics Directive. With certain other legislation it now provides the basis for the marketing of cosmetics with safe ingredients, across the EU. • Although the new legislation is a Regulation in contrast to the former, which was a Directive, it is still basically Old Approach, even though standardization plays a part in the legislative system

10. The New Approach • The New Approach Resolution of 1985 and • The Global Approach Resolution of 1989 • between them have established a basis for a much more efficient approach to harmonization based on a legislation with a system of Essential Requirements for public protection and the means to assess whether they are being conformed with.

11. New Approach Legislation • There are four principles that act as the basis for New Approach legislation. • In the legislation itself, principles for public protection – health, safety, certain environmental requirements, public (consumer) protection - should be expressed as goal-setting Essential Requirements not the technical specifications for achieving them. • Technical Specifications should, instead, be included in harmonized Standards produced by the three European Standards organizations (ESO) under Mandates (contracts) from the European Commission to produce Standards in support of EU product Directives or Regulations.

12. New Approach principles • 3. The use of those Standards by manufacturers is voluntary but: • once the standards have been accepted by the Commission and their titles have been published in the Official Journal of the EU and the standards have been published by at least one national standards body in the EU • 4. Products made in accordance with those standards gain the Presumption of Conformity with the Essential Requirements (ERs of the relevant legislation – at least to the extent that the Standards cover those ERs.

13. Commentary on the New Approach • The use of standards is voluntary but it is the most straight forward way to comply with the Essential Requirements of product Directives • If manufacturers wish to use their own distinctive non-Standard or non-EU standard way of manufacturing, that does not make the product non-compliant with the Directives but: • They may need to demonstrate to the EU Market Surveillance Authorities how they have achieved compliance • It may – depending on the conformity assessment provisions of the Directive – limit their choices of conformity assessment procedure

14. The CE marking

15. CE marking (continued) • The CE marking is the manufacturer’s claim that his product complies with all the Directives (CE marking/ New Approach Directives) that apply to his product • CE-marked products should be allowed free circulation in the EU Internal Market unless Market Surveillance Authorities have good reason to believe that the product is, in fact, non-compliant. • Depending on the precise terms of the applicable legislation, the CE marking must be applied to the product or its packaging • It is NOT a Quality Mark – it is a manufacturer’s claim to compliance

16. Conformity Assessment – Global Approach • The principles of Conformity Assessment in New Approach Directives were laid down in the Global Approach Resolution of 1989 • The need for Conformity Assessment along with the four New Approach principles forms the basis of New Approach legislation.

17. Conformity Assessment • Important principles for manufacturers to note: • Manufacturers are always responsible for ensuring that their products comply with EU legislation even where that legislation requires a Third Party Conformity Assessment Procedure and the use of a Notified Body. • If a product is non-compliant when it is placed on the market, the manufacturer is still responsible and accountable for that situation, even if it has used a Notified Body and even if that Body has certified the product as being compliant with the legislation. • Manufacturer must ensure that, in that situation, it takes all necessary action to rectify the situation and bring the product into conformity or take it off the market

18. Obligations of Notified Bodies (NBs) • NBs must carry carry out conformity assessments (CA) in accordance with the CA procedures laid down in the applicable legislation • They must do it in a proportionate manner – avoiding unnecessary burdens for economic operators • They shall require manufacturers to take any necessary action to bring products into compliance with the legislation before issuing a conformity certificate • If subsequently, NBs find products no longer comply, they must require manufacturers to take corrective action, and - if necessary - restrict, suspend or withdraw certificates

19. Information obligations of Notified Bodies • NBs must inform their notifying authorities of; • Refusals etc of certificates • Circumstances affecting the scope of & conditions for notification • Any request for information from market surveillance authorities regarding C.A. activities • On request, C.A. activities performed

20. Conformity Assessment Procedures • Before Products are placed on the market they must comply with the Conformity Assessment Procedures (CAP) laid down in the Directives the apply to them (may well be more than one Directive) Depending on the particular Conformity Assessment Procedures (CAP) specified in applicable Directive(s), the CAP may involve examination by a Notified Body of the design of the product, the production of the products or Quality Assurance system for design and/or manufacture of the product

21. Conformity Assessment Procedures – the future • The long-term aim of the EU is to align all its existing legislation to the conformity assessment procedures laid down in Decision 768/2008/EC on a common framework for the marketing of products • It is legitimate for legislators to modify these procedures when drafting individual Directives or EU Regulations e.g. where a rational risk assessment leads to the conclusion that that is the right approach but such departures need to be justified • The table in the next slide summarizes the conformity assessment procedures in 768/2008/EC. In the hand-out that accompanies this presentation are included the Conformity Assessment tables from Decision 768/2008/EC for Design and Production

22. EU Conformity Assessment Procedures

23. Questions often asked • Q: Do I need an Authorised Representative (AR) in the EU? • A: According to Decision 768/2008/EC’s Article R3, you do not have to have one but you may choose to appoint one by a written Mandate • Q: What responsibilities can I give/ can I not give to an AR? • A: This is explained in Article R3 and in the hand-out that accompanies this presentation • Q: Are there any exceptions? • A: You must check the provisions of individual Directives e.g. the Pyrotechnics Directive (2013/29/EU) does not provide for the appointment of ARs • Q: How do I find out which conformity assessment procedure applies to my product? • A: You have to study the legislation and make sure you comply. Many Directives make extensive use of “Module A” – e.g. low voltage electrical equipment; many types of machinery. But remember Module A does not mean no controls apply – manufacturers must have satisfactory systems of internal production control to comply with it • Q: How do I find a Notified Body? • A: They are listed in the E. Commission’s NANDO database • http://ec.europa.eu/enterprise/newapproach/nando/index.cfm

24. Thank you • Thank you for listening • Richard Lawson • richardandrosemary@btinternet.com