On 7 May, the European New Approach to harmonisation and standards celebrates its 35th birthday (Council Resolution 85/C 136/01). The New Approach emerged in the spirit of the 1980s when many governments and world organisations were focusing on market liberalisation and deregulation.

The New Approach guarantees the protection of citizens’ health and safety rights, eliminate technical obstacles to the free movement of goods and replace the inefficient, slow system of harmonising the regulation of the Member States of the European Community (now: European Union). This system of product safety applies throughout the European internal market.

A significant innovation is that Technical Regulations should not be prescriptive and must refer to reference standards. The European Standards Institutions are in charge to develop the voluntary reference standards with the participation of all interested parties.

“The authorities are obliged to recognise that products manufactured in conformity with harmonised standards are presumed to conform to essential requirements.” [1] If a manufacturer does not produce in compliance with these standards, he must prove that his products conform to the essential requirements. 

Overall, the New Approach strives for coherence between a total harmonisation of objectives in security and safety matters with a flexible approach to the means of standardisation.

New Legislative Framework

The European regulatory model has evolved over the years. A “New Legislative Framework” was established in 2008 and set the CE Mark as a “passport” for the European market and Notified Bodies as invigilators for pre-market approval and surveillance. The CE marking is, therefore, not a seal of quality. The mark indicates that the company which places the product in the market is aware of the specific requirements of the product and guarantees conformity.

The New Legislative Framework does work on a “presumption of conformity” basis. It contains additional requirements for manufacturers such as risk analysis and obligations regarding withdrawal in case of reasonable suspicion of conformity defects. If non-compliant products make it to the EU market, the manufacture is responsible and need to take action.

The New Approach has worked well in many product areas such as machinery, toys and electronic consumer products, where it has helped to improve EU competitiveness and enhance innovation. Even if the New Approach is generally accepted, there is also criticism. Industry representatives complain that the process of drawing up harmonised standards is no longer industry-driven, but increasingly bureaucratic and politicised.[2]

The impact of the New Approach is lasting, not only in ensuring the success of a standardised set of product regulations but in facilitating the mostly free movement of products within all EU member states and further developing the single European market. An important interface is the Rapid Alert System (RAPEX) database, which publishes product safety warnings regularly. The platform provides a valuable service to both the consumer and retailer as a transparency tool. For the manufacturer, it is a means of keeping up to date with compliance issues and avoiding the consequences that come with non-compliance.

Brazils new regulatory model

Can the European regulatory model be transferred to developing and emerging countries? On 6 April 2020, Brazil has launched a regulatory model inspired by the ideas of the New Approach [3].

The problem with the previous product safety system in Brazil was that it only covered 12% of all products. Also, technical regulations often contained detailed technical specifications, which were seen by companies as an obstacle to innovation.

With the new regulatory model, Brazil is introducing an organisational risk assessment based on the European model. For low-risk products, the self-declaration of the manufacturer is to be accepted. More self-declaration may lead to a decrease in demand in the field of certification. On the other hand, companies could continue to use third-party certification as proof of compliance.

As part of the reform, the Brazilian National Institute of Metrology, Standardization and Industrial Quality (INMETRO) is building a database that will help distinguish between products with low and high health, safety and environmental risks. Such a system has been in operation in the European Union for a long time. It remains open how much effort will be needed to establish an equivalent system in Brazil.

Conclusions

The increased role of the private sector and voluntary standards in the field of technical regulations and market surveillance has many advantages:

1. The use of reference standards leaves the technical specification in the hands of market participants and thus enables innovation
2. Product risk analysis allows the state to concentrate its control function on those products that may pose a threat to the safety and health of the population.
3. The possibility of self-declaration strengthens the self-responsibility of industry and reduces state intervention and public resources.
4. By using designated testing laboratories and certification bodies (“the notified bodies”), the system makes use of accreditation and also strengthens the Quality Infrastructure.

In principle, these advantages apply equally in industrialised and developing countries. In the case of Brazil, however, it remains to be seen to what extent the industry is capable of self-regulation. The danger is that the self-declaration could be misused to dispense with verification by an accredited conformity assessment body to save costs. The establishment of a functioning database to assess products according to their risks to health, safety, and the environment is a significant challenge. The Brazilian reformers still need to prove whether the new regulatory model will strengthen the National Quality Infrastructure System and increase consumer protection.

References

[1] EU Legislation, A new approach to technical harmonisation [Retrieved 03/05/2020]

[2] Business Europe (2019): Strategy Paper – The way forward for the New Approach,    [Retrieved 03/05/2020]

[3] Costa, R. R., et al. (2019). Novo Modelo Regulatório para o Inmetro – Diagnóstico e Proposta de um Novo Modelo Regulatório com base na atuação da Dconf., Instituto Nacional de Metrologia, Qualidade e Tecnologia (Inmetro), Xerém

Featured picture by iStock.com/dusanpetkovic Ulrich Harmes-Liedtke