Summary of the PhD Thesis Quality Assurance Strategies for Certain Chemical Products within the Frame of the

European Market Exigencies

Scientific Coordinator: Prof. Univ. Dr. Rodica Pamfilie PhD Student: Maria-Camelia Sur a) TABLE OF CONTENTS Introduction 1. Sustainable Development Priority at the European Union Level 1.1. Environmental Action Programmes and the Integrated Product Policy 1.2. The main domains of impact related to environmental protection 1.3. Environmental Standards Specifics 1.4. Voluntary Agreements recommended tools for the environmental management 2. European Regulatory Environment related to Chemical Substances and Preparations 2.1. The European Union Directives: scope, areas of intervention, roles and responsibilities 2.2. The European regulations for the classification of chemical substances and preparations 2.3. The European regulations for the control of chemical substances and preparations 2.4. Regulations regarding certain chemical substances and preparations 3. The Regulatory-Institutional Framework Pertaining Chemical Substances and Preparations in Romania 3.1. Regulatory harmonization in the field of dangerous chemical substances and preparations with the acquis comunitaire directives 3.2. Methodological Norms in the field or chemical substances and preparations 3.3. Relevant regulatory authorities in Romania with roles in the field of chemical substances and products 3.4. Horizontal and Procedural Measures for the approximation of the regulatory environment in the field of chemical substances and preparations 4. Harmonization Trends in the field of chemical products quality assurance 4.1. Recent trends in European chemicals legislation 4.2. REACH System the European Union Future legislation in the field of chemicals 4.3. Arguments in favour of new legislation on chemicals at the European Union level 4.4. Voluntary Initiatives and the International harmonization of the chemical legislation

5. Strategic Provisions regarding the Quality Assurance of certain chemical products

5.1. Strategic landmarks of the chemical products management 5.2. Strategic management of the chemical products quality 5.3. Fighting the counterfeiting practices related to certain chemical products 6. Identifying Quality Assurance Strategic Elements at Procter&Gamble 6.1. Current approach pertaining to quality assurance for the P&G products 6.2. Evolution of the quality-research activities 6.3. Procter&Gamble Quality Assurance System 6.4. Specific actions in the field of consumer protection and environmental protection 7. Designing a Monitoring and Reporting system for chemical substances and preparations 7.1. Monitoring and Reporting Systems - essential element of the integrated chemicals management system 7.2. The specific framework related to data gathering, structuring and processing in the field of chemicals 7.3. SEREChim Monitoring and Reporting System for chemicals operational tool at micro and macroeconomic level Conclusions Annexes Bibliography b) KEY WORDS voluntary agreement, audit, chemical products quality, total quality, environmental quality, certification, sustainable development, European directives, TQM, integrated product policy, action environmental programmes, REACH system, quality assurance system, standard. c) SYNTHESIS of the key parts of the PhD thesis The thesis analyses from various perspectives the current background of existing the regulations in the field of management of chemical substances and preparations, in the context of the legal-institutional framework in the European Union and Romania. Several important insights that were considered in the process of defining quality assurance strategies for certain chemical products in the context of the European market were the deep understanding of the spirit and approach of the European directives and regulations and also the differences between the two systems, the European Union one and the Romanian one. This is very important especially due to the fact that currently, the European Union legislation related to chemical substances and preparations is subject of a serious process of revision, a process that was initiated back in 1998 by the European Council.

This paper is structured in seven chapters and the first chapter approaches the sustainable development as a priority of the European Union. The first research study was oriented in several directions with impact on the quality assurance strategies for certain chemical products within the context of the European market. The first direction was to carry out a study of the current trends in the field of sustainable development. The concept of sustainable development integrates the economic progress, social development and the environmental protection matters with the objectives of securing a quality life for the future generations. These three factors are interrelated and together can lead to an improvement of the quality of life but none of them is sufficient by itself. Sustainable development proved to be essential not only in the fields of production and consumption but also in relation with the trade mechanisms. Just as the environmental assessment takes into consideration the full life cycle of a product, the trade should be also looked upon as an integrated system. In the global economy of the 21st century the governmental policies and collective or individual practices have an ever increasing long-term influence on the environment and the way the citizens, the industry, the authorities and the international organisations manage to implement solutions for environmental protection is becoming essential. One of the goals of this thesis was also the study of these policies and the analysis of the successful implementation possibilities. Chapter 1 refers to one of the most important strategies aimed to reach the objectives of sustainable development, namely promoting a coherent legislative system at the European Union level. The Environmental Action Programmes represent in this sense the documents on which the environmental policies of European Union are based on. They actually consist of long term programmes combination correlated through a strategic way, considering both vertical and sectorial approaches of the environmental aspects. One of the novelties brought by the Environmental Action Programmes is a change of the direction in terms of environmental policy toward a policy based on consensus, a policy that includes the dialog with all the parties concerned in the decision making process. This actually represents switching from an approach based on control to another one based on prevention, which is enhanced by operational economic and fiscal tools. The European Union exigencies related to the impact of the quality of chemical products on environment are getting higher. The most advanced approach in European Union, meant to reduce the negative impact on the environment, is nowadays the integrated pollution prevention and control. This concept refers at the same time to three elements of the environment: the quality of the air, of the water and waste management. There are approximately 200 legislative acts (directives, regulations, decisions) that represent the horizontal and vertical legislation in the field of environmental protection at the

European Union level. The horizontal legislation consists in regulations related to transparency, provision of a smoother decision-making process and involving the society in environmental protection. On the other hand, the vertical (sectorial) legislation refers to the sectors that are part of the environmental policies such as waste management, sound pollution, water and air pollution, preservation of biodiversity, soil protection and civil protection. The most important horizontal initiatives may be considered: integrated product policy, that takes into account the environmental impact during the entire life of a certain product; environmental standards, that can be defined in a formal way by international bodies as International Standardization Organization (ISO) or they can have a voluntary character; eco labelling that offers the consumers information related to ecological products; voluntary agreements concluded between industry and public authorities, meant to reach specific environmental targets. They are recommended tools in the field of environmental management no matter their format: as declaration of intention or as written commitments. Among the voluntary agreements benefits there are the proactive approach from the industry side, the efficiency of the solutions, specifically designed for particular problems and the rapid implementation process that can lead to the completion of the environmental objectives. Chapter 2 identifies the trends related to the development of the chemicals market regulations in Europe and provides an assessment on the current status of the European legislative framework related to chemicals. The directives related to the control of the chemicals regulate the domains of production, marketing, formulation, packaging, classification and labelling. The European Union Directives do not regulate the quality itself in terms of product performance. In many industrial areas (especially in the dynamic ones) it is not feasible to define the notion of performance in terms that would allow the carrying on of efficient controls. When applied inappropriately, the regulations regarding performance may lead to the delay or even blockage of the technological innovations and industrial development. Separately, the forces of the free competitive trade can guarantee a high quality and performance. The modern regulations in the field of industrial domain, such as European directives are, intently avoid the control of performance, promoting this way the economic development at an optimal level. The European directives, as other regulatory systems of the high developed markets, especially focus on the human safety and environmental protection, offering at the same time freedom for innovation and technological development. The European system is in this respect, one of the best in admitting the

importance of the fast science development. Thats why almost each directive has a provision regarding the adapting to the technical progress. The European regulations related to the classification, packaging and labelling of the chemical substances and preparations are currently under a detailed revision process of the European Commission. The aim is to secure a new commitment from the industry and from the member states to solve the issues related to the existing chemical substances (the ones placed on market before 1981). The European Inventory of Existing Chemical Substances (EINECS) includes 100,106 substances. Out of these, there were collected information for 2,500 substances of high production volume (above 1,000tons/year) and 7,000 substances of low production volume (between 10tons/year 100 tons/year). So far 110 substances of high priority have been identified; however the evaluation process was concluded just for 21 chemicals until now. The low number of substances assessed so far is one of the major weaknesses of these regulations. The objective of this revision is to harmonise these directives with the international progress and development. In this chapter there are also studied the European regulations related to the specific chemical substances and products such as pesticides, biocides and cleaning products. The third chapter where there are analyzed the trends in the harmonisation of the regulations regarding quality assurance of the chemical products in Romania, highlights the fact that the rapid rhythm of the past three years led to the transposition of the legislation related to chemical products in a high percentage of approx. 90%, and this year its implementation will also start. The approximation of the national legislation with the specific European directives is a complex process. The regulations regarding chemicals are numerous and under constant improvement at the European Union level. That is why a thorough understanding of the acquis communittaire and building the necessary infrastructure for implementing it represents a complex and lengthy process. In chapter no. 3 there are also studied the horizontal procedures for the approximation of the legislation related to dangerous chemical substances and preparations. The Romanian legislation related to dangerous chemical substances and preparations, regulates the specific requirements for placing dangerous chemicals on the market by economic agents: manufacturers, importers, distributors and/or users. The methodological norms for applying the regulations related to chemical substances and preparations stipulate the classification procedures for these chemicals. These norms also set the testing methods for physico-chemical, toxicological and eco-toxicological analyses for some dangerous chemical substances and preparations. The National Agency for Dangerous Substances and Preparations (ANSPCP) is the competent authority in Romania, responsible with the control of the regulatory implementation. ANSPCP is in direct link with the European Chemical Bureau.

During the previous centralized economy, specific for Romania before 1989, the product conformity assessment was done within system based on mandatory state standards (STAS) for assessing the quality of products and services. Today, in the field of certification, for the Romanian industry, there are 10 officially certified bodies for the certification of the quality management systems and three officially authorized bodies for the certification of the environmental management systems. Another target of the study was to highlight the particularities of the national market surveillance system which is managed by the National Authority for Consumer Protection (ANPC). ANPC is also the National Point of Contact for the TRAPEX system (Transitional Rapid Exchange of Information on Dangers Arising from the Use of Dangerous Products) that helps solve emergency situations related to the use of products of serious and immediate risk. The Chapter 4 highlights the trends in the approximation of the regulatory requirements related to the quality assurance of chemical products and also the current directions and priorities of the European legal framework of chemicals. The current regulatory system of chemicals is too slow, too complex and not transparent enough. The lack of available public information led to an increased public concern about chemicals, especially if we take into account that during the past 70 years the volume of chemicals grew approximately 400 times. All these weaknesses are supposed to be solved by the new policies in the field of the chemical products through the new system or chemicals control REACH. The main purpose of the new European Union policy in the field of chemical substances and preparations is sustainable development and securing a high level of protection of health, security for human and for environment by preserving and developing the industrial competitiveness, by preventing the fragmentation of the internal market and by enhancing a unique system for both new and existing chemical substances. Today, we are sure that the current legal background regarding chemicals will be significantly amended and the industry will have more responsibilities than before in this direction. Some chemical substances will most probably disappear due to the fact that the companies will not deem it profitable to pay for registering them. Some studies show that approximately 20% of the chemicals present on the market today may disappear in future. This chapter presents also an analysis of the aspects related to the effects of the implementation of the new regulatory system REACH and identifies the arguments in favour of this new policy of the European Union in the field of chemicals. The White Book, published in 2001, outlines the strategy of the new policy on the future management of the chemicals that revises the main legal tools in the field: the directives related to the dangerous chemical substances and preparations. Among the main principles of the White Book are:

a switch of the responsibilities for proving the safety of a chemical substance or product from the authorities to the industry. the substances proved to be dangerous will have to be substituted with safer alternatives. The companies that would use these types of substances will have to prove that there are no better alternatives available. the same rules will be applied to both new and existing substances. The new policy regarding the management of chemicals aims to address the weak points of the current system, especially: the lack of a thorough knowledge of the potential hazard for numerous chemical substances and preparations, the too slow process of risk assessment, the complexity that represents a burden for innovation process and the uneven distribution of resources between the existing chemicals versus new chemicals introduced on the market. REACH system the revolution of the European policy on chemicals is a unique and coherent regulatory system including both the existing substances (those present on the market before 1981) and the new ones, introduced on the internal market of the European Union after 1981. The lead time for implementing REACH system is estimated to last between 2007 2018. Accordingly to this system, the industry is responsible to prove the safety in use for the chemical substances and preparations during the entire chain from the producer to the distributor. In this context, the voluntary initiative of the industry play a key role, being meant to support the authorities to avoid the costs related to the implementation of the regulations. The industry in the chemistry field supports an integrated approach of the economic and environmental objectives where the authorities set the frame directions. Few of these pilot initiatives, that support the principles of the new approach in relation with the chemical substances and preparations management, were studied from their mechanism and impact points of view: The Good Environmental Practice Code the International Association for Soaps, Detergents and Maintenance Products (AISE) HERA project (Human and Environmental Risk Assessment) is the first model of voluntary agreement within industry having as an objective the risk assessment for the ingredients used in the cleaning products, in a transparent way A fundamental element of the chemicals legislation revision pertains to its international dimension. This legislative restructuring should also keep the pace with the similar international initiatives. The goal of the global dialog regarding the harmonization in the field of chemicals is to identify international solutions to the problems which are essentially international. This Global Harmonized System for Chemicals Classification (GHS)

is meant to communicate the hazard level of the chemical substances and preparations and also to reduce the testing duplications and to facilitate the international trade of chemicals. Chapter no. 5 presents a different research direction by defining some strategic projections regarding the quality assurance for certain chemical products and by identifying some key elements of the chemicals management. The chemical industry is into a high degree already globalized in many aspects. The technology, together with the globalization and the pressure of the actions towards environment protection represent factors that can set the future trends in the chemical industry. For the management of the chemical industry, as well as for other industrial domains, there are several strategic key elements that proved to be extremely efficient for building a successful business. Three key factors were identified that together can lead to excellent results: quality, innovation and the differentiation through the trademark name. The investment in research and development, together with the requirements of the global market, are the main factors that led to the strengthened position of the industry in the past years and certainly this trend will continue this way. The innovation, the product quality and intellectual property aspects lead to a force that can secure the success of a business. Thats why the investment in these fields proved to be more efficient for developing and growing a business versus the traditional investments. In this context the current paper presents a study of the revolutionary bases of the total quality management and quality assurance via international standards systems. Quality assurance based on the European or international standardization systems gets to be more and more present on the Romanian market as well. Romania already finalized the adoption of the European standards. The international standards ISO 9000 type related to the management of quality are the most well-known for their efficiency in securing an appropriate system of quality assurance. This chapter presents also a study regarding the protection against counterfeiting practices related to chemical products. In this respect several specific recommendations were made that may lead to the eradication of the counterfeited products and of the unfair competition practices. The counterfeited products are infringing upon the intellectual property regulations, the consumer protection regulations and the ones related to the product safety. Furthermore, these counterfeited products generate trust issues among consumers and it created harmful precedents for a civilized trade within a fair competition market. The big challenge is to constantly prevent the counterfeited product occurrence and this can be done via two parallel approaches: a short term one and a long term one. The goal of the short term approach is to significantly reduce the marketing of the counterfeited products and it refers to particular situations at a certain point in time. The long term approach however should take into consideration a few key elements:

building an appropriate infrastructure that would allow rapid and efficient actions discussion and assessment sessions for improving the current relevant legislation; turning the illegal counterfeiting businesses into legal businesses with genuine products Chapter no. 6 focuses on the quality assurance strategic elements at Procter&Gamble. The policies in the fields of quality assurance and consumer protection are part of the P&G culture. Among several key aspects related to a market of quality products there are: the creation of an appropriate quality for products and services, elimination of the out of specifications products and of the counterfeited products. This culture of quality developed through more than 160 years led to the superior quality products as a result of thorough research and extended testing that prove the in use safety. The quality is determined by the requirements and desires of the consumers. Chapter no. 6 contains also an analysis of the evolving trends related to quality research and some tools used in the field of innovation. Initially, the evaluation systems for research and development were closely linked to the technical performance of the product. There were mainly emphasized the patents of innovations and the generation of new innovations within the company. The focus was not necessarily on the value perceived by the consumers related to those innovations. With more than 20.000 patents of innovations and more than 200 new technologies per year, P&G is considered to be one of the most innovative companies in the world. The most recent structure of the research and developing department integrates more efficiently the technical innovation with the commercial one. The market encourages the innovation by rewarding those ideas that supports people the most. As much as we need technological innovations we also need innovation at a social level. That is why this chapter presents a research related to consumer needs as well as several types of qualitative and quantitative research. The P&G Quality Assurance System was developed based on the Malcom Baldrige Award criteria, the ISO 9000 standards and based on the Good Manufacturing Practices that include some of the most not-flexible regulations and also based on the companys own experience. The P&G quality assurance program at global level contains the quality assurance itself and also an audit of the Good manufacturing practices and a close follow up of the results obtained on the production lines. Furthermore, the regular audit in the field of quality is performed by the Central Department for Quality Assurance. P&G designed quality standards for each of its product categories. The P&G Quality assurance system is based on 19 key elements for quality assurance which are presented in this chapter. This chapter presents also the activities in the field of environmental management and the importance of product labelling for safety and quality assurance. One of the elements identified to be essential for the integrated management of chemicals in an organization that produce, manipulate and use chemical substance as such

or under the format of items is also the monitoring and reporting system. In this respect, the research performed in the chapter 7 has also had as an objective to design a monitoring and reporting system for the chemicals called SEREChim. SEREChim is an operational tool that can be used at micro- and macro-economic level. This system takes into account the practical implications related to the integrated management of chemicals and it can also fulfil the needs of an organisation that aims to implement a performant quality assurance system. Additionally the SEREChim reporting system can be successfully used in the field of chemical management by the relevant authorities with responsibilities in this field due to its functions that allow data processing for a large number of economic agents. In order to design this monitoring and reporting system for chemical substances and preparations there were identified the specifics of the integrated reporting systems in the context of production and use. The SEREChim system was also designed in the context of the national and European legislative framework, taking into account also the practical implications related to integrated management of chemicals.

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