Technical Assistance in the field of Chemicals

Approximation Strategy on Chemicals
Draft 1
Client:
Ministry of Environment & Forestry
Prof. Mustafa Öztürk
Bakanklıkar
Teach Consortium

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Technical Assistance in the field of Chemicals

Resume
Projecttitle / : / TeACH
Projectnumber / 197928
Documentnumber / :
Revision / : / 1
Date / : / 15th of November 2006
Author(s) / : / Adina Relicovschi, Cristina Ivan, Gulun Egeli, Sema Alpan, Serpil Apaydin, Ferd Schelleman
e-mail address /

Checked by: / : / Gulun Egeli
Approved by: / : / Ferd Schelleman

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Technical Assistance in the field of Chemicals

Table of Contents

1Introduction

2Purpose and Approach

2.1Purpose

2.2Approach

3Priorities and goals of the sector

3.1EU Policy on chemicals

3.2EU legislation: brief overview and the link with other EU environmental acquis

3.2.1Directive 67/548 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances as amended, so called Dangerous Chemicals Directive

3.2.2Directive 99/45 on concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, so called Dangerous Preparations Directive

3.2.3Directive 1993/67/EEC on the principles for assessment of risks to man and the environment of substances notified

3.2.4Directive 2001/58/EC on Safety Data Sheet

3.2.5Interrelation with other EU legislation in the environmental acquis

3.2.6International chemicals programmes

4Existing situation

4.1Turkish chemicals sector

4.2Existing legal framework

4.3Existing institutional framework

4.4Ministry of Environment and Forestry (MoEF)

4.5Ministry of Health (MoH)

4.5.1Refik Saydam Hygiene Center

4.6Ministry of Labour and Social Security (MLSS)

4.6.1Occupational Health and Safety Center (ISGUM)

4.7Ministry of Agriculture and Rural Affairs (MARA)

4.7.1Agricultural Pest Control Central Research Institute (ZMMAE)

4.8Tobacco, Tobacco Products and Alcoholic Beverages Market Regulatory Authority (TAPDK)

4.9Other pertinent stakeholders

4.9.1State Planning Organisation

4.9.2Undersecreteriat for Foreign Trade

4.9.3Under-secretariat for Customs

5Transposition and implementation plan

5.1Transposition plan

5.2Implementation Plan

5.2.1Designation of the competent authority/es in charge with the implementation of the chemical legislation

5.2.2Setting up of procedures and work methodology of the competent authority/es

5.2.3Information collection on chemicals, data processing and management

5.2.4Supevision, control and enforcement actions

5.2.5Training of the staff involve in the implementation process

5.2.6Information and communication programme

5.2.7Reporting requirements

5.2.8Overview of the implementation actions

5.2.9Further action needed to complete institutional strengthening

6Cost assessment and financial plan

6.1Cost assessment

6.1.1Introduction

6.1.2Cost summary

6.1.3Financial plan and financial resources

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Technical Assistance in the field of Chemicals

1Introduction

Starting 2001 when a Government Decree was adopted on the Implementation, Co-ordination and Monitoring of the “National Programme for the Adoption of the Acquis” (NPAA), amended in 2003, significant progress was recorded as concerns the harmonisation of the EU acquis communauitaire, and particularly the promotion of the environment management in Turkey as well as concerning the legislative harmonisation process, taking into account environmental policy integrated approach into sectorial policies and also the strengthening necessity of building capacity at the national and provincial level.

Transposition and implementation of the acquis in the environmental sector are part of a complex process, mostly due to the inter-sectorial character and to the impact these problems have on the entire Turkish economy, bringing environmental requirements in line with the European quality standards. This process involves significant costs and structural changes in the Turkish economy and in the legal and governmental structure.

The current Approximation Strategy on Chemicals sets out Government policy in ensuring fully transposition, as well as implementation and enforcement of the EU acquis on Chemicals sectors with focus on 4 EU Directives, respectively:

Directive 67/548 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances as amended;

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations;

Directive 1993/67/EEC on the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC;

Directive 2001/58/EC on Safety Data Sheet (amending Directive 91/155/EEC and Directive 93/112/EC).

This current strategy has been developed in close collaboration between all relevant departments of the Ministry of Environment and Forestry, as well as based on several discussions with the representatives of other line ministries with responsibilities related to chemicals management. Support was provided through the current EU funded project “TA in the field of chemicals”.

The Strategy is based on a thorough assessment of all achievements and remaining gaps in the chemicals sectors and on a review of all related legal acts and existing institutional framework, as well as the assessment of the existing sector approximation strategy, basedon the following approach:

first, to identify the gaps between the Turkish chemicals legislation and policies and those of the EU,

second, to decide the steps that will be taken in order to fully transpose and implement the acquis of the chemical sector, and

third, to develop a plan for financing necessary investments and actions, to ensure implementation and enforcement of the transposed legislation.

Taking into account the opening of the negotiation process between Turkey and European Commission on 3rd of October2005, Turkey is in the full process of transposing, and implementing the acquis, in the view of opening the negotiation on environmental chapter based on its Position Paper for the chapter 27 - Environment.

In its way to accession, Turkey has to undertake the necessary measures in order to ensure the respecting of the political and economic criteria, and to assume its capacity of membership, especially in ensuring the full transposition and implementation of the acquis.

In order to fully respond to EU requirements within environmental sector in general and management of chemicals in particular, Turkey should focus further efforts on developing implementation capacities and should ensure that laws include realistic deadlines and cost assessments, and are only proposedfollowing sufficient consultation. At the provincial level, significant resources are needed toimprove the status of existing staff, to recruit new inspectors, and to train them adequately.Co-ordination between ministries on environmental issues needs to be improved and Turkeyshould integrate environment protection requirements into the definition and implementationof all other economical sectoral policies so as to promote sustainable development.

In this context, the key benchmarks of the current strategy include:

Complete an overall assessment of the situation in the chemicals sector in order to identify gaps to be filled.

Continue with the complete transposition of the chemicals legislation in all remaining areas.

Ensure progress with the implementation of the transposed acquis, including through securing the necessary financial resources.

Enhance the administrative structures necessary for full implementation of the chemicals legislation, through reinforcement of staffing both in the Ministry and in other relevant bodies, including at provincial levels.

Develop implementation plans together with financing strategies, to outline the steps needed to ensure full implementation in the medium and longer term. These plans should take into account available resources and institutional strengthening, and further elaborate mechanisms to monitor effective implementation.

Improve the manner in which legislation is prepared by allowing for full consultation with stakeholders (including other Ministries, economic operators and NGOs), and giving full consideration to the implementation requirements, including a thorough assessment of the implementation costs.

It is anticipated that the achievement of the milestones set out in the current strategy will be closely monitored by the Government, and the schedule and activities will be revised as necessary to ensure that Turkey fulfils its commitment to implement the environmental acquis by the date of accession.

2Purpose and Approach

2.1Purpose

The purpose of this Approximation Strategy for Chemical sector is to ensure that the Turkey has taken and will take all necessary steps to fully implement and comply with the EU environmental acquis within chemical sector by the date of accession.

It represents the up-dated version of the existing sector Approximation Strategy in the Chemicals and Genetically Modified Organismsector as part of the overall Integrated Environmental Approximation Strategy for the Turkish Republic, including a series of activities designed to prepare the Turkish Republic for membership in the European Union, dating from April 2004and prepared by Ministry of Environment and Forestry with the support of an EU Technical Assistance Project.

2.2Approach

This Approximation Strategy on Chemicals is based on the process set out in the Association Agreement, as regularly revised and the Accession Partnership, as well as the confirmation of Turkey’s candidate country status by the Helsinki European Council in 1999. The European Union, at the Copenhagen Council of 12-13 December 2002, committed itself to open the negotiation process without delay if it determines, on the basis of the recommendation of the European Commission on Turkey’s progress towards accession, which was made available to the public on 6th of October 2004. In October 2005 the negotiation framework has been set-up and the process formal opened.

The accession planning process is driven by the National Program for the Adoption of the Acquis (NPAA) adopted by the Turkish Government in March 2001, further amended in May 2003, identifying short and medium-term priorities, administrative arrangements and financial needs to meet the EU requirements. The NPAA, sets out the TurkishRepublic’s commitment to transpose the entire chemical legislation by the end of 2006 and to carried out a detailed analysis of the existing situation, as well as to propose implementation plans for the relevant EU Directives included in the sector by the same period. The current strategy fully responds to the commitments included in the NPAA.

The principles upon which this Approximation Strategy on Chemicals is based reflect the European Council’s conclusions laid down on 24 of September 1998 on Accession Strategies for the Environment, especially those one requiring the development of a strong and well-equipped administration to implement and enforce the new laws and programmes which are prescribed by the EU environmental acquis to be considered as a priority.

During the period of March – October, 2006, a detailed assessment of the state of compliance with and implementation of the environmental acquiswithin chemicals sector was carried out under the leadership of the Ministry of Environment and Forestry. This detailed transposition and implementation gap assessment became the baseline for the preparation of directives specific implementation actions plans.

Taking into account that the detailed assessment of the current situation underlined that the relevant national chemicals legislation has not yet been substantively implemented, the relevant implementation plans have been developed and included in the current strategy. On this basis, the interactions and relationships between each directive relevant for the sector and the legal acts within and outside the sector were identified and deeply assessed.

At each stage, the relevant stakeholders were consulted individually and in a series of workshops on the findings and proposed actions.

Thus, as shown below, three levels of planning activity has been carried to completion during March – November 2006:

Objective / Output
Identification of transposition status for all 4 directives subject of assessment /  / Detailed legal Gap Analysis based on EC Table of concordance
Identification of implementation achievements and gaps /  / Baseline studies for 4 Directives
Documentation of completed implementation, focused on existing institutional framework /  / Institutional report
Identification of approximation costs for 4 directives /  / Relevant administration costs identified and included in the strategy
Detailed implementation action plans /  / Directive-specific Implementation Plans (DSIPs)
Financial planning /  / Financial plans identifying sources of research and investment funding
Drafting the Approximation Strategy on Chemicals /  / Draft Approximation Strategy on Chemicals

3Priorities and goals in the field of Chemicals Management

The use of chemicals has become an essential means for achieving economic and social development. To make such development “sustainable”, the benefits of chemicals must be maximized and their health and environmental impacts minimized. There should be legal and technical infrastructure for safe producing, handling and placing on the market of chemicals.

Sound management of chemicals implies not only safe use of chemicals based on identification and assessment of risks to human health and the environment, but also a broader approach addressing the production, processing, formulation, transport, distribution, use and disposal of chemicals following a life cycle approach. It should encompass linkages to pollution prevention and life cycle management.

In preparing the strategy and identifying its priority actions, as well as considering the timetable of implementation, key considerations have been taken into account provided by the EU policy within chemicals sector which, with the aim to avoid harm to the environment or to human health through environmental exposure to chemicals, and taking into account the progresses made and the difficulties encountered in the implementation of EU legislation on chemicals, is putting priorities on:

making full information publicly available about the environmental risks of chemicals;

continue reduction of risks presented by chemicals to the environment and human health - while maintaining the competitiveness of industry;

phase out early those chemicals identified as representing an unacceptable risk to the environment.

At country level, these goals can only be achieved effectively through partnership between Government, the chemical industry and other stakeholders nationally and through active participation to international initiatives such as the Organization for Economic Co-operation and Development (OECD) chemicals programme, as well as strong cooperation with EU organizations such as the European Chemicals Bureau for better understanding of the fate and effects of chemicals in the environment and coordination of risk-management programmes.

It must be noted, that the current approximation strategy is focused on the four EU Directives mentioned in the introductory part of the document, being principally aimed at the much larger number of chemicals produced, imported and used by industry for a variety of purposes, which in the main are not subject to positive approval procedures. The marketing and use of chemicals which are designed to be biologically active, including pesticides, biocides and human and veterinary medicines, are or will be subject of specific permitting procedures and are not considered here. It does not include exposure to chemicals in the workplace, but it is important to recognize that actions taken to reduce environmental risks can have implications for workplace health and safety. It is understandable that in preparing the sectorial approximation strategies the Governmental responsible bodies will ensure that strong links are in place between the two policy areas. The strategy does also not cover the transport of dangerous chemicals or major accident hazards, which are covered by specific legislation.

Box 1:Scope of the Approximation Strategy on Chemicals
The approximation Strategy on Chemicals deals with the relevant legislation related to:
risks to the environment and to human health through environmental exposure to commercially available chemicals;
the commercial production and use of such chemicals;
measures relating to controls on production and use. / The approximation Strategy on Chemicals does not consider the legislation related to:
pesticides, biocides and human and veterinary medicines;
exposure to chemicals in the workplace;
transport of dangerous chemicals or major accident hazards;
measures relating to controls on emissions of chemicals to the environment.

The successful implementation of the approximation strategy on chemicals depends upon the following internationally accepted principles underpinning the formation of national policies on the sustainable production and use of chemicals:

Sustainable development: Sustainable development is about ensuring a better quality of life for everyone now and for generations to come. It seeks simultaneously to deliver social progress which recognizes the needs of everyone, effective protection of the environment, prudent use of natural resources, and maintenance of high and stable levels of economic growth and employment.

Precautionary principle: This is enshrined in the 1992 Rio Declaration on Environment and Development, stating: “In order to protect the environment, the precautionary approach shall be widely applied by states according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”.

Proportionality principle: Control measures should generally follow the principle that the response should be proportional to the risk.

Polluter pays principle: Polluters should assume responsibility for environmental impacts under the polluter pays principle. Much environmental pollution occurs because those responsible are not those who bear the consequence. If asking polluters to pay for those consequences gives incentives to reduce harm, that means that costs do not fall on society at large.

Free trade: The General Agreement on Tariffs and Trade (GATT) under the World Trade Organization requires non-discrimination between imported and domestically produced products. Measures which are necessary to protect the health of humans, plants and animals within national boundaries or that relate to the conservation of exhaustible natural resources are allowed so long as they are justified and not a disguised restriction on international trade.

3.1EU Policy on chemicals

The adoption of the directive on the classification, packaging and labelling of dangerous substances(67/548/EEC) provided the first controls over the use of hazardous chemicals. It established acommon system for the classification and labelling of such substances before they are marketed andlays down procedures to be used to establish the physico-chemical and toxicological properties ofsubstances which might present a risk under conditions of normal usage. The directive hasundergone a number of amendments reflecting changes to its scope and purpose. It has alsoundergone numerous “Adaptations to Technical Progress” (ATPs) by means of CommissionDirectives that implement and change items of a more technical nature from within the Directive andits major amendments. The broad thrust of this legislation is to establish a common system acrossEU Member States and so prevent barriers to trade by the introduction of different national standards.