National Institute of Metrology, Standardization and Industrial Quality Inmetro - Brazil

1. THE BRAZILIAN PROGRAM OF TOY CERTIFICATION Milan, November 18th, 2010 Leonardo Rocha Substitute Manager of the Conformity Assessment Programs Division National Institute of Metrology, Standardization and Industrial Quality Inmetro - Brazil

2. Inmetro • Founded in 1973 • Governmental Institution • 1,150 employees • 60 laboratories • 100,000 m2 (built area)

3. MISSION To provide confidence to Brazilian society in measurements and products, through metrology and conformity assessment, promoting harmonization of consumer relations, innovation and competitiveness of the country.

4. ACTIVITIES • Scientific and Industrial Metrology; • Legal Metrology; • Focal Point for WTO Agreement on Technical • Barriers to Trade; • Accreditation of Certification Bodies, Calibration and Testing Laboratories; • Conformity Assessment. Inmetro’s activities have a wide impact in the country’s life.

5. CONFORMITY ASSESSMENT Concept The Conformity Assessment is a systematic process with pre-established rules, properly monitored and evaluated, in order to provide adequate degree of confidence that a product, process, service or a professional meets pre-established requirements in standards or regulations, with the lowest possible cost to society.

6. CONFORMITY ASSESSMENT Concept Degree of Confidence The ideal point is located in this region. Cost Need to balance appropriate degree of confidence at the lowest possible costto society.

7. CONFORMITY ASSESSMENT Goals • Instrument of consumer protection. • Instrument of industrial development, by encouraging continuous quality improvement. • Adding value to product brands. • Provide confidence in consumer relations. • Instrument of competitiveness in domestic and foreign trade, by promoting fair competition, protection of domestic market and increase exports. The benefits are for all segments of society.

8. CONFORMITY ASSESSMENT Mechanisms used in the Brazilian System of Conformity Assessment - SBAC • Certification (compulsoryorvoluntary) • Management System • Product • Person • Supplier’sDeclarationofConformity (compulsory) • Labeling (compulsoryorvoluntary) • Inspection (compulsory) • Testing (compulsoryorvoluntary) Different needs  Different Mechanisms

9. CONFORMITY ASSESSMENT Numbers Total ofConformityAssessmentPrograms = 268 Total ofDevelopedPrograms = 164 (134 C + 30 V) ImplantedPrograms = 126 UnderImplementationPrograms = 38 DevelopingPrograms= 104

10. CONFORMITY ASSESSMENT Examples

11. CONFORMITY ASSESSMENT Forms of Evidence

12. CONFORMITY ASSESSMENT Market Surveillance Systematic process of monitoring the market, aiming to prevent the marketing of products that do not meet the technical regulations. • Inspection: (basedonthe package informationchecking) • Focuses on formal aspects of the product, identifying products that have not undergone the process of conformity assessment. • ConformityChecking: (basedontheproductintrinsicalanalysis) • Focuses on improvement of Conformity Assessment Program, by identifying products that have passed through the process of conformity assessment, but for some reason, are on the market without meeting the prescribed technical requirements.

13. CONFORMITY ASSESSMENT Market Surveillance Decentralized activity, held in national level, through the delegated bodies that compose the Brazilian Network of Legal Metrology and Quality (RBMLQ-I)

14. CONFORMITY ASSESSMENT OF TOYS Brazilian Toy Market • Units sold annually: 150 million (Source: ABRINQ) • Annual sales volume: U$ 1.1 billion (Source: ABRINQ) • Share of imported toys: 45% (Source: ABRINQ) • Number of manufacturers installed in Brazil: 441 (Source: ABRINQ) • Number of certificate toys sold since the implantation of the regulamentation: 3 billion (Source: ABRINQ) • Number of Accredited Certification Bodies: 6 (Source: Inmetro) • Number of Accredited Laboratories: 7 Brazil + 2 China (Source: Inmetro) • 27 years without accidents involving toys made in Brazil (Source: ABRINQ) • The toy industry in Brazil has no problems with environmental agencies, including Green Peace (Source: ABRINQ)

15. CONFORMITY ASSESSMENT OF TOYS History • 1992 – Based on a national standard (ABNT EB-2082) or equivalent international standard • 1998 – Based on a national standard (ABNT NBR 11786:1998) • 2005 – Based on a Mercosur Standard (NM 300:2002) • ISO Systems of Certification: 4, 5 and 7 • Requirements: Physical and Mechanical Properties, Inflammability, Electrical Properties, Hygiene, Radioactivity, Chemical Properties, Noise, Warning and Identification of Age. • Annual Audit of Quality Management System (ISO 9001)

16. CONFORMITY ASSESSMENT OF TOYS History • 2006/2007 – Consumer accidents around the world motivated the announcement of many recalls by the toy world industry • 2007 – Using the precautionary principle, Brazil change the procedures to toy certification (temporary) • The same requirements (NM 300:2002) • National Products: ISO Systems of Certification 5 and 7 • Foreign Products: ISO Systems of Certification 7 • Tests only in national accredited laboratories • 2007 – Additional requirements for toxicological testing (Phthalates)

17. CONFORMITY ASSESSMENT OF TOYS Actually • 2009 – New procedures to toy certification • Requirements: NM 300:2002 + requirements for toxicological testing • National and foreign Products: ISO Systems of Certification 5 and 7 • Artisans, Micro and small enterprises: ISO Systems of Certification 4 • Qualification requirements for the Conformity Assessment Body professionals • Sworn translation of the test report • Complaint Handling Policy • Conformity Checking

18. CONFORMITY ASSESSMENT OF TOYS Actually • ISO System of Certification 5 • National and international laboratories accredited by Inmetro or by signatories to the ILAC • Audit of Quality Management System with variable frequency (4 / 8 / 12 months) related to the company's compliance history • Flexible requirements for Micro and Small Enterprises for the Quality Management System • Requirements for sampling • Validity of the certificate: 4, 8 or 12 months

19. CONFORMITY ASSESSMENT OF TOYS Actually

20. CONFORMITY ASSESSMENT OF TOYS Actually • ISO System of Certification 7 • National and international laboratories accredited only by Inmetro • Requirements for sampling

21. CONFORMITY ASSESSMENT OF TOYS Actually

22. CONFORMITY ASSESSMENT OF TOYS Actually • ISO System of Certification 4 • National and international laboratories accredited only by Inmetro • Requirements for sampling • Validity of the certificate: 12 months (Micro and small enterprises) • 18 months (Artisans) • Confirmation Test: 6 months later (Micro and small enterprises) • 9 months (Artisans)

23. CONFORMITY ASSESSMENT OF TOYS Actually

24. CONFORMITY ASSESSMENT OF TOYS Form of evidence

25. CONFORMITY ASSESSMENT OF TOYS Related Actions • 2010 – Inmetro is developing more two Conformity Assessment Programs related to children products • School Articles • Party Articles • 2010 – Inmetro supports the development of an international standard on safety of toys.

26. Contacts: • Inmetro’s Home Page: • http://www.inmetro.gov.br • Questions to Inmetro: • dqual@inmetro.gov.br • Consumers Site: • www.portaldoconsumidor.gov.br