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TeACHTechnical Assistance in the field of Chemicals

Approximation Strategy on Chem-icalsDraft 1

Client:

Ministry of Environment & Forestry

Prof. Mustafa ÖztürkBakanklıkar

Teach Consortium


Resume

Project title : TeACH

Project number 197928

Document number :

Revision : 1

Date : 15th of November 2006

Author(s) : Adina Relicovschi, Cristina Ivan, Gulun Egeli, Sema Alpan, Serpil Apaydin, Ferd Schelleman

e-mail address [email protected]@euteachproject.com

Checked by: : Gulun Egeli

Approved by: : Ferd Schelleman

mailto:[email protected]

mailto:[email protected]


Table of Contents

1 Introduction............................................................................................5

2 Purpose and Approach............................................................................72.1 Purpose...................................................................................................72.2 Approach................................................................................................7

3 Priorities and goals of the sector.............................................................93.1 EU Policy on chemicals........................................................................113.2 EU legislation: brief overview and the link with other EU environ-

mental acquis........................................................................................133.2.1 Directive 67/548 on the approximation of laws, regulations and admin-

istrative provisions relating to the classification, packaging and la-belling of dangerous substances as amended, so called Dangerous Chemicals Directive.............................................................................13

3.2.2 Directive 99/45 on concerning the approximation of the laws, regula-tions and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, so called Dangerous Preparations Directive.............................................15

3.2.3 Directive 1993/67/EEC on the principles for assessment of risks to man and the environment of substances notified.........................................16

3.2.4 Directive 2001/58/EC on Safety Data Sheet........................................163.2.5 Interrelation with other EU legislation in the environmental acquis....163.2.6 International chemicals programmes....................................................18

4 Existing situation..................................................................................214.1 Turkish chemicals sector......................................................................214.2 Existing legal framework......................................................................224.3 Existing institutional framework..........................................................284.4 Ministry of Environment and Forestry (MoEF)...................................284.5 Ministry of Health (MoH)....................................................................344.5.1 Refik Saydam Hygiene Center.............................................................354.6 Ministry of Labour and Social Security (MLSS).................................364.6.1 Occupational Health and Safety Center (ISGUM)...............................384.7 Ministry of Agriculture and Rural Affairs (MARA)............................384.7.1 Agricultural Pest Control Central Research Institute (ZMMAE).........394.8 Tobacco, Tobacco Products and Alcoholic Beverages Market Regulat-

ory Authority (TAPDK).......................................................................404.9 Other pertinent stakeholders.................................................................404.9.1 State Planning Organisation.................................................................404.9.2 Undersecreteriat for Foreign Trade......................................................414.9.3 Under-secretariat for Customs..............................................................44

5 Transposition and implementation plan...............................................465.1 Transposition plan................................................................................465.2 Implementation Plan.............................................................................475.2.1 Designation of the competent authority/es in charge with the imple-

mentation of the chemical legislation...................................................48


5.2.2 Setting up of procedures and work methodology of the competent au-thority/es...............................................................................................62

5.2.3 Information collection on chemicals, data processing and management..............................................................................................................62

5.2.4 Supevision, control and enforcement actions.......................................635.2.5 Training of the staff involve in the implementation process................635.2.6 Information and communication programme.......................................645.2.7 Reporting requirements........................................................................645.2.8 Overview of the implementation actions..............................................645.2.9 Further action needed to complete institutional strengthening.............65

6 Cost assessment and financial plan......................................................676.1 Cost assessment....................................................................................676.1.1 Introduction..........................................................................................676.1.2 Cost summary.......................................................................................686.1.3 Financial plan and financial resources..................................................68


1 Introduction

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 con-cerns 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 integ-rated 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 environ-mental requirements in line with the European quality standards. This process in-volves 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 adminis-

trative 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 classifica-tion, 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 relev-ant departments of the Ministry of Environment and Forestry, as well as based on several discussions with the representatives of other line ministries with respons-ibilities related to chemicals management. Support was provided through the cur-rent EU funded project “TA in the field of chemicals”.

The Strategy is based on a thorough assessment of all achievements and remain-ing gaps in the chemicals sectors and on a review of all related legal acts and ex-isting institutional framework, as well as the assessment of the existing sector ap-proximation strategy, based on 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

Documentnumber:


· 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 - Envir-onment.

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 imple-mentation of the acquis.

In order to fully respond to EU requirements within environmental sector in gen-eral and management of chemicals in particular, Turkey should focus further ef-forts on developing implementation capacities and should ensure that laws in-clude realistic deadlines and cost assessments, and are only proposed following sufficient consultation. At the provincial level, significant resources are needed to improve 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 Turkey should integrate environment protection requirements into the definition and implementation of 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, in-

cluding 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 out-line 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 op-erators 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.


2 Purpose and Approach

2.1 PurposeThe 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 Organism sector as part of the overall Integrated Environmental Approximation Strategy for the Turkish Republic, in-cluding a series of activities designed to prepare the Turkish Republic for mem-bership in the European Union, dating from April 2004 and prepared by Ministry of Environment and Forestry with the support of an EU Technical Assistance Pro-ject.

2.2 ApproachThis 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 Com-mission 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 Adop-tion of the Acquis (NPAA) adopted by the Turkish Government in March 2001, further amended in May 2003, identifying short and medium-term priorities, ad-ministrative arrangements and financial needs to meet the EU requirements. The NPAA, sets out the Turkish Republic’s commitment to transpose the entire chem-ical legislation by the end of 2006 and to carried out a detailed analysis of the ex-isting 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 re-sponds to the commitments included in the NPAA.

The principles upon which this Approximation Strategy on Chemicals is based re-flect the European Council’s conclusions laid down on 24 of September 1998 on Accession Strategies for the Environment, especially those one requiring the de-velopment of a strong and well-equipped administration to implement and en-force the new laws and programmes which are prescribed by the EU environ-mental 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 acquis within chemic-als sector was carried out under the leadership of the Ministry of Environment


and Forestry. This detailed transposition and implementation gap assessment be-came the baseline for the preparation of directives specific implementation ac-tions plans.

Taking into account that the detailed assessment of the current situation under-lined that the relevant national chemicals legislation has not yet been substant-ively 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 out-side 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 com-pletion during March – November 2006:

Objective OutputIdentification 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 im-plementation, 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 invest-ment funding

Drafting the Approximation Strategy on Chemicals

Draft Approximation Strategy on Chemicals


3 Priorities 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 minim-ized. There should be legal and technical infrastructure for safe producing, hand-ling 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, trans-port, 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 consider-ing the timetable of implementation, key considerations have been taken into ac-count provided by the EU policy within chemicals sector which, with the aim to avoid harm to the environment or to human health through environmental expos-ure to chemicals, and taking into account the progresses made and the difficulties encountered in the implementation of EU legislation on chemicals, is putting pri-orities 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 unaccept-

able 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 Chemic-als Bureau for better understanding of the fate and effects of chemicals in the en-vironment 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 princip-ally 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 acci-dent 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 le-gislation related to: · risks to the environment and

to human health through en-vironmental 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 le-gislation related to: · pesticides, biocides and hu-

man and veterinary medi-cines;

· 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 de-pends 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 eco-nomic growth and employment.

· Precautionary principle: This is enshrined in the 1992 Rio Declaration on Environment and Development, stating: “In order to protect the envir-onment, the precautionary approach shall be widely applied by states ac-cording to their capabilities. Where there are threats of serious or irre-versible 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 en-vironmental impacts under the polluter pays principle. Much environ-mental 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 im-ported and domestically produced products. Measures which are neces-sary to protect the health of humans, plants and animals within national boundaries or that relate to the conservation of exhaustible natural re-


sources are allowed so long as they are justified and not a disguised re-striction on international trade.

3.1 EU Policy on chemicalsThe 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 a common system for the classification and labelling of such substances before they are marketed and lays down procedures to be used to establish the physico-chemical and toxicological properties of sub-stances which might present a risk under conditions of normal usage. The direct-ive has undergone a number of amendments reflecting changes to its scope and purpose. It has also undergone numerous “Adaptations to Technical Progress” (ATPs) by means of Commission Directives that implement and change items of a more technical nature from within the Directive and its major amendments. The broad thrust of this legislation is to establish a common system across EU Mem-ber States and so prevent barriers to trade by the introduction of different national standards.

The key requirement of EU policy on chemicals ask for, before placing controls on a chemical substance, assessment whether it is hazardous and whether its use entails risks for human health or the environment. In this context the word “haz-ardous” is used to describe a property that is intrinsic to a substance. The word “risk” relates to the likelihood of harm and therefore depends on exposure, in-cluding the way the substance is used or is likely to reach the environment. Haz-ard assessment is therefore a first step to an assessment of risk.

Under EC legislation for assessing chemicals, two separate regimes have been in-troduced, one relating to “new” chemicals and one to “existing” chemicals. Exist-ing chemicals are defined as those listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) which includes over 100,000 that were on the European Community market between January 1971 and September 1981. All other chemicals are considered “new”.

Existing Substances: The Existing Substances Regulation (793/93/EEC) came into effect in 1993 and introduced a scheme for assessing “existing” chemicals as defined above. Of the 100,000 plus chemicals listed in EINECS, some 20,000 or so are currently on the market.

For practical reasons, the Regulation involves substantial prioritisation of effort. Risk assessments are shared between Member States. Manufacturers or importers who make or supply more than certain quantities of existing substances have to send existing data needed for risk evaluation to the European Commission. This data is used to draw up lists of priority substances to be examined in more detail. The lists are then adopted by a technical committee comprising representatives of the Member States.

The substances on the priority lists are assessed by Member State rapporteurs and, if necessary, proposals are made for risk reduction. So far over one hundred chemicals have been listed for priority attention (three priority lists have been agreed). However, despite completion of a number of risk assessments by the rap-porteurs, none has yet reached the stage of agreed action. Assessments under the Existing Substances Regulation have progressed slowly for a number of reasons, including the need to develop standardised methodology for risk assessment, and the complexity of the assessments. The first risk reduction proposals under the Regulation were agreed in 1999.


The Existing Substances Regulation also provides an additional mechanism by which Member States can obtain information about specific chemicals on EINECS which are not already passing through the assessment procedure but which they believe may present a serious risk to human health or the environ-ment. Article 12(2) allows individual Member States, subject to approval by a regulatory committee comprising representatives of the Member States, to request manufacturers or importers to supply the information about a specific chemical that they already possess and/or subject that chemical to further testing and sup-ply a report thereon.

New Substances: Under an EC Directive that came into effect in 1979 (revised in 1992: 92/32/EEC), a new chemical can only be placed on the market if the manu-facturer or importer submits a notification to a competent authority (the compet-ent authority is a body or bodies nominated by Member States). The notification includes the results of tests to evaluate possible harmful effects on humans and the environment (only in place since 1992), and may include an assessment of the risks that may arise. The authority passes the results to the European Commission which relays them to the authorities in other Member States. If no objections are raised within 60 days of the notification, the manufacturer has assured access to the whole EU market. The Directive thus allows notifiers to make their own as-sessment before marketing, although this is audited by Member States.

The procedures for notification of new substances have been broadly successful in meeting their aim of securing a single European market in chemicals whilst en-suring that such chemicals are properly evaluated. Some sectors of the chemical industry find the legislation burdensome and a barrier to innovation, despite the derogations for research and development within the Directive. They consider that the costs of tests at quantities above the exemption threshold are dispropor-tionate. This is particularly important to small and medium-sized enterprises (SMEs).

Marketing and Use Directive: There are two primary routes in Europe for intro-ducing measures to restrict or ban dangerous substances: the European Commis-sion has the right of initiative to make proposals for restrictions; and individual Member States are able to develop proposals for national measures, which must be notified to the Commission under a procedure set out in the Technical Stand-ards Directive (98/34/EC).

The legislative framework for such proposals is provided by EC Directive 76/769/EEC, the Marketing and Use Directive, which harmonises Community measures to control the marketing and use of dangerous substances. The restric-tions made under the Directive are listed in an accompanying annex that is sub-ject to amendments by subsequent directives.

Classification and labelling: The classification and labelling requirements under the Dangerous Preparations Directive and part of the Dangerous Substances Dir-ective (DSD) require suppliers to identify the hazards of substances and prepara-tions under 15 descriptive categories (called classifications)

Simple Legislation for the Internal Market (SLIM): The European Commis-sion's review of legislation “Simple Legislation for the Internal Market” (SLIM) has included in the Dangerous Substances Directive (67/548/EC) review, which sets out European standards for the above regulations on the notification of new substances and on classification and labelling.


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

3.2.1 Directive 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

Directive 67/548/EEC is the oldest piece of EU legislation regulating the chemic-als sector. It deals with the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances placed on the Community market. Main provisions refer to:· The distinction between existing substances (i.e. placed on the Com-

munity market before 1981 – EINECS) and new substances (i.e. placed on the EC market after 1981 – non-EINECS).

· The classification of the substances in one of the 15 classes specified and labelling according to the criteria established in Annex VI of the Direct-ive. Annex I includes the new and existing substances whose classifica-tion and labelling have been officially agreed at Community level.

· The notification of substances: MS must ensure that manufacturers and importers placing for the first time a substance on the Community market notify the CA of the MS where they place the substance. The data re-quired to be provided in the notification are in direct relation with the quantity of the substance notified. The “base set” notification includes in-formation which should allow identification of environmental, health and physico-chemical hazards.

· The confidentiality of the data submitted by the notifier.

· The exchange of information on the substances notified.

· Exemptions from the obligation to notify a new substance.

· The assessment of the potential risks posed by the substances to human health and the environment, to be carried out (Art. 3.2) on the basis of the principles adopted in Directive 93/67/EEC laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC.

· The rules concerning packaging, labelling, and exemptions thereof.

The Directive was subjected to 9 amendments and 30 ATPs. Of these, the 6th amendment introduced the notification of new substances, while the 7th amend-ment provided for the risk assessment of notified substances. As regarding the annexes, Annex I includes the list of substances classified as dangerous. Danger symbols (such as a skull with crossed bones underneath) are applied to substances in Annex II. Standard phrases on the nature of special risks from substances (R-phrases) appear in Annex III. The wording of safety precau-tion phrases (S-phrases) relating to the handling and use of dangerous substances is found in Annex IV. Annex V contains testing methods to determine the danger-ous properties of substances. Annex VI provides detailed criteria on the proper choice of the class of danger and on how to assign the danger symbols and R- and S-phrases to a tested substance. Annexes VII and VIII do not relate to the classi-fication or labelling of substances, but to the notification of “new” substances. Annex IX includes provisions on child-proof fastenings and tactile warning devices including special packaging and labelling elements.


The proper implementation of the Dangerous Substances Directives requires key legal and institutional considerations to be taken into account as recommended by the EC “Handbook for the implementation of environmental legislation”, as fol-lowing:· Substances should not be allowed to be placed on the market unless they

have been notified in accordance with specified criteria and procedures (Arts. 5, 7, 8 and 9, 10 and 15) subject to the exemptions listed in Article 13 of Directive 67/548. In this regard, it is necessary to establish a pro-cedure for notification of new substances by manufacturers, importers and distributors. These procedures should maintain industrial and com-mercial secrecy.

· The substances must be packaged and labelled in accordance with spe-cified criteria and procedures (Arts. 5, 22, 23, 24 and 25 of Directive 67/548). A mechanism to ensure that all substances are packaged and la-belled in accordance with the directive must be established.

· The placing on the market of substances that comply with the Directive, for reasons relating to notification, classification, packaging or labelling must not be restricted, unless the restriction is temporary and is imposed in accordance with specified conditions (Arts. 30 and 31). This could be achieved: at the same time as installations are inspected for other envir-onmental or health and safety purposes, by a specific inspection or in-spection in the market place.

· Establish a procedure to ensure that dangerous substances are not advert-ised in breach of the Directive’s requirements (Arts. 26 and 2).

· Establish a mechanism to ensure that manufacturers, importers and dis-tributors provide safety data sheets to users of dangerous substances. A system of compliance monitoring must be established to ensure that SDSs are provided and accurate.

· Guidance should be designed for manufacturers, importers and distribut-ors on the notification procedure and the requirements relating to classi-fication, packaging and labelling of dangerous substances.

· Establish a procedure for carrying out risk assessment by the competent authority which receives the notification of a new substance.

· Criteria for temporarily restricting marketing and use of a notified sub-stance if it is believed to present a danger for health or the environment should be established and made available. The Directive does not oblige to adopt this possibility of temporary restriction.

· Establish procedures and criteria for maintaining industrial and commer-cial secrecy.

· Ensure that notifiers of substances that have already been notified inform the competent authority of changes in quantities placed on the market and of new knowledge about the substance (Art. 14, subject to exemptions listed in Article 13 of the Directive).

· Ensure that manufacturers, importers and distributors carry out investiga-tions into the properties of dangerous substances that appear in the EINECS, but which have not yet been introduced into Annex I of the Dir-ective (Art. 6 of Directive 67/548).

· Establishing a mechanism to provide reports to the Commission on: noti-fications to place substances on the market; the use of alternative la-belling; prohibitions or restrictions on the sale of dangerous substances; and transposition and implementation of the Directive.


· An adequate system of penalties for non-compliance will be required to provide an incentive for manufacturers and importers to meet the require-ments of the directive.

· It is necessary to appoint a competent authority (or authorities) to receive and assess information from manufacturers and importers about sub-stances to be placed on the market, and ensure that competent authorities carry out their duties in accordance with prescribed principles (Art. 16 “Rights and Duties of the Authorities, and Commission Directive 93/67/EEC on RA principles for notified substances).

· The choice of a competent authority will require care, because of the many government bodies with a legitimate interest in the directive.

· Where more than one competent authority is appointed tasks must be clearly allocated, for example, receiving notifications, carrying out risk assessments and communicating with the Commission.

· Training or recruitment may be required to ensure that the competent au-thority/ies is adequately equipped to complete the risk assessments re-quired.

· The directive has a potential impact on many stakeholders, and as a result great care must be taken to consult widely. Stakeholders involved include not only companies and their workers, together with their representatives, but also environmental bodies, accident control authorities, emergency services, and wide range of NGOs and government departments.

3.2.2 Directive 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

Directive 99/45/EEC specifies the hazard classification, packaging and labelling requirements for chemical preparations (mixtures or solutions composed of two or more substances). Main provisions refer to:· The evaluation of intrinsic hazards of chemicals.· The scope of the Directive, together with the exceptions thereto (prepara-

tions in the finished state intended for the final user or to the carriage of dangerous preparations or those in transit under customs supervision).

· The same 15 classes of dangerous substances and preparations as provided for in Directive 67/548/EEC.

· The methods for determining the dangerous properties of preparations and lists general principles of classification and labelling according to the degree and specific nature of the hazards involved.

· The procedures for evaluating health hazards and environmental hazards.· The rules concerning packaging, labelling, and exemptions thereof.

According to the Directive, MS must:· Take measures to ensure proper packaging and labelling of dangerous

preparations, and that the persons responsible for placing the preparation on the market provides a data sheet.

· Appoint a body responsible for receiving information relating to such preparations.

As regarding the annexes, Annex I, II and III refer to methods for the evaluation of physico-chemical, health hazards and respectively environmental hazards. An-nex IV comprises special provisions for containers containing preparations offered or sold to the general public. Annex V includes Special provisions con-cerning the labelling of certain preparations, and Annex VI refers to the confiden-


tiality for the chemical identity of a substance. Annex VII presents the prepara-tions which due to the form in which they are placed on the market do not present risks. Annex VIII refers to directives repealed, etc., while Annex IX presents a correlation table.

The key institutional requirements for the proper implementation of the Directive as recommended by the EC “Handbook for the implementation of environmental legislation” are link to those provided for EU Directive on Dangerous Substances and the legal considerations to be taken into account include:· Establish measures to ensure persons placing preparations on the market

retain the data used for classification, labelling,· Establishing the safety data sheet, and the information relating to pack-

aging requirements.· Ensure that the label of all preparations placed on the market satisfies the

requirements of this Directive.· Ensure that the packaging of all preparations is escape proof, not suscept-

ible to adverse attack by the preparations, carry warnings, and child proof.

· Ensure the packaging of all preparations does not arouse the curiosity of children, mislead consumers, and in no way resembles the packaging of human or animal food products or medical and cosmetic products.

· Ensure safety data sheets for all preparations packaging are produced.· Create guidance material for stakeholders where appropriate.· Create monitoring and enforcement systems to ensure preparations that

are in breach of then requirements of the Directive are not placed on the market.

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

As already mentioned, Directive 67/548/EEC mentions in Article 3.2 that the po-tential risk to man and the environment must be assessed on the basis of the prin-ciples adopted, by 30 April 1993. Namely, these principles are established by Directive 93/67/EEC laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC.

3.2.4 Directive 2001/58/EC on Safety Data SheetSafety Data Sheet Directive 2001/58/EC (amending Directive 91/155/EEC and Directive 93/112/EEC) refers to the safety data sheet which needs to be prepared for professional users by the person responsible for placing a chemical substance or preparation on the Community market, including as well in the Annex a Guide to the Compilation of the SDS.

3.2.5 Interrelation with other EU legislation in the environmental ac-quis

Summary of key relationship between the key legislation subject of the current approximation strategy under chemicals sector and other EU legislation in the en-vironmental acquis is presented below:

Good Laboratory Practice (GLP) Directives 87/18/EEC and 88/320/EEC: Particular care must be granted to the interrelationship between the GLP Direct-ives and the legislation concerning specific chemicals when drafting national im-plementing legislation. Directive 87/18/EEC requires MS to ensure that laborator-ies carrying out tests on chemicals or chemical products for regulatory purposes apply GLP principles, while Directive 88/320 EEC adds various requirements


with respect to the monitoring and inspection of laboratories applying GLP Prin-ciples to ensure compliance with the GLP principles.

Seveso II Directive 96/82/EC on the control of major-accident hazards in-volving dangerous substances: The Seveso II Directive aims to prevent major accidents that involve dangerous substances and to limit their consequences for people and the environment. The Directive applies to establishments at which cer-tain dangerous substances are present in sufficiently large quantities to create a major accident hazard. As well as requiring the operators of such establishments to take preventive measures the Directive places a number of procedural require-ments on Member States relating to planning, policy integration, inspection, re-porting and public access to information.

Directive 91/414/EEC concerning the placing of plant protection products on the market: This Directive harmonises the overall arrangements for authorisation of plant protection products within the EU by harmonising the process for consid-ering the safety of active substances at a Community level by establishing agreed criteria for considering the safety of those products. Product authorisation re-mains the responsibility of individual Member States. The Directive provides for the establishment of a positive list of active substances (Annex I), that have been shown to be without unacceptable risk to people or the environment. Active sub-stances are added to Annex I of the Directive as existing active substances are re-viewed (under the European Commission (EC) Review Programme) and new ones authorised. Member States can only authorise the marketing and use of plant protection products after an active substance is listed in Annex I, except where transitional arrangements apply.

Directive 98/8/EC concerning the placing of biocidal products on the market: Directive 98/8/EC requires the authorisation of a wide range of biocide products currently not requiring authorisation (including disinfectants, preservatives and a number of other specialist products) as well as non-agricultural pesticides. (i.e., wood preservatives, public hygiene insecticides, etc.). Only biocidal products which contain an active substance which is listed on Annex I of the Directive will be authorised for use.

Existing and new active substances have to be evaluated to ascertain whether or not they can be included on the Annex I list.

Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes: Although thie Directive also deals with certain aspects of safety tests required under EC chemicals legislation, it is mainly concerned with the harmonisation of the protection of animals used for certain experimental purposes. Another major aim of the directive is the reduction of the number of an-imal experiments. This should be achieved by the mutual recognition of test res-ults.

Council Regulation 304/2003 concerning the export and import of dangerous chemicals: This Regulation implements the Rotterdam Convention on Prior In-formed Consent, the 'PIC procedure’, repealing the former Council Regulation 2455/92. It requires: a mandatory notification procedure for all exports of chemic-als that are banned or whose use is severely restricted within the Community, that chemicals are exported at least six months before their expiry date, and that that exports to countries outside of the Community are packaged and labelled to at least the standard of those for sale in the Community. Furthermore it forbids the exports of substances that are banned for use within the Community.


Council Directive 87/217/EEC on the prevention and reduction of environ-mental pollution by asbestos aims to prevent and reduce pollution by asbestos, in order to protect human health and the environment: it requires Member States to restrict emissions of asbestos into the air and discharges of asbestos into water, and to take precautions when carrying out certain activities involving asbestos, such as the demolition of buildings and the transport and disposal of waste. It also lays down monitoring requirements.

Regulation (EC) No. 2037/2000 of the European Parliament and of the Coun-cil on substances that deplete the ozone layer (as amended) establish rules on the production, import, export, supply, placing on the market, use, recovery, re-cycling and reclamation and destruction of substances that deplete the ozone layer. It implements the Montreal Protocol to the Vienna Convention for the Pro-tection of the Ozone Layer, but lays down more stringent requirements and pro-hibitions than the Protocol for phasing out CFCs (chlorinated fluorocarbons), HCFCs (halogenated fluorocarbons) and methyl bromide. The Regulation also in-troduces an import licence system that is administered by the Commission.

3.2.6 International chemicals programmesNational and European activities on chemicals are part of a wider international structure, coordinated by the Intergovernmental Forum on Chemical Safety (IFCS) and the Inter-organisation Programme for the Sound Management of Chemicals (IOMC). These bring together a range of chemical programmes under the UN Environment Programme (UNEP), International Labour Organisation (ILO), UN Food and Agriculture Organisation (FAO), World Health Organisation (WHO), UN Industrial Development Organisation (UNIDO), UN Institute for Training and Research (UNITAR) and Organisation for Economic Co-operation and Development (OECD).

IFCS was established to co-ordinate national and international efforts to promote chemical safety and to oversee implementation of the programme on environ-mentally sound management of chemicals set out in Chapter 19 of Agenda 21, ad-opted by the Earth Summit in 1992 (see box 1 below). The six programme areas in Chapter 19 are being taken forward by a range of voluntary, national and re-gional measures, and when necessary by international agreements.

The World Summit on Sustainable Development held at Johannesburg in 2002 (Rio+10) strongly reaffirmed the commitment to the Rio principles, the full im-plementation of Agenda 21, and the Programme for Further Implementation of Agenda 21. Concerning chemicals, the plan of implementation establishes 2020 as a target for usage and production of chemicals in ways that lead to the minim-ization of significant adverse effects on human health and the environment. Seven actions are envisaged to reinforce the 6 programme areas adopted at Rio:· Promote the ratification and implementation of relevant international in-

struments on chemicals, such the Rotterdam Convention on PIC Proced-ure;

· Further develop a strategic approach to international chemicals manage-ment;

· Encourage countries to implement the new globally harmonized system (GHS) for the classification and labelling of chemicals;

· Encourage partnerships to promote activities aimed at enhancing environ-mentally sound management of chemicals;

· Promote efforts to prevent international illegal trafficking of hazardous chemicals;


· Encourage development of coherent and integrated information on chem-icals, such as through national pollutant release and transfer registers;

· Promote reduction of the risks posed by heavy metals that are harmful to human health and the environment

The programme of expansion and acceleration of international chemical risk as-sessments (Area A in box) is supported by necessary hazard data.

The OECD hazard assessment programme investigates the hazards of chemicals produced in quantities of at least 1,000 tonnes per year in at least one OECD country. OECD continues the development of a set of test guidelines which are widely used across the world to measure and evaluate the toxicity and other prop-erties of chemicals, and has agreed on the minimum data required to determine whether or not a chemical requires further investigation and has been agreed that members of the OECD to work together to provide this minimum data set for a particular chemical. Information is collected from government, public and in-dustry sources and, where necessary, by additional testing.

Once all the necessary information has been collected on a chemical, the country leading the review makes an evaluation which includes conclusions on potential risks and recommendations for further action, if appropriate. The information col-lected and the sponsor country's report is subjected to peer review.

Results of the OECD programme are co-ordinated by the international organisa-tions and made widely available to all countries through the UN International Programme on Chemical Safety (IPCS). The mutual acceptance of data generated to internationally accepted standards prevents unnecessary duplication of testing. The test data is used within a number of national and international risk assess-ment programmes, including that under the European Community's Existing Sub-stances Regulation. The International Council of Chemical Associations has an-nounced a voluntary programme of accelerated testing and hazard assessments of about 1,000 of the 4,100 high production volume chemicals currently identified by the OECD.

Box 2: Chapter 19 of Agenda 21

Chapter 19 of Agenda 21 (adopted by the 1992 Earth Summit in Rio) dealt with the environmentally sound management of toxic chemicals. It pro-posed action programmes in six areas:

Area A: the expansion and acceleration of international chemical risk as-sessments;

Area B: harmonisation of chemical classification and labelling;

Area C: information exchange on toxic chemicals and chemical risks;

Area D: establishment of risk reduction programmes;

Area E: strengthening of national capabilities and capacities for manage-ment of chemicals; and

Area F: stopping illegal international traffic in toxic and dangerous products.

It also laid the basis for the Intergovernmental Forum on Chemical Safety to oversee implementation of the six programme areas.

The advance of the six action programmes will benefit the sound manage-


ment of chemicals, helping to protect the environment and enhancing world trade.

Rotterdam Convention on the Prior Informed Consent Procedure for Cer-tain Hazardous Chemicals and Pesticides in International Trade: The Rotter-dam Convention is a multilateral environmental agreement designed to promote shared responsibility and cooperative efforts among Parties in the international trade of certain hazardous chemicals, in order to protect human health and the en-vironment from potential harm and to contribute to their environmentally sound use by facilitating information exchange about their characteristics, providing for a national decision-making process on their import and export and disseminating these decisions to Parties.

In other words, the Convention enables the world to monitor and control the trade in certain hazardous chemicals and it is not a recommendation to ban the global trade or use of specific chemicals it is rather an instrument to provide importing Parties with the power to make informed decisions on which of these chemicals they want to receive and to exclude those they cannot manage safely.

If trade takes place, requirements for labeling and provision of information on po-tential health and environmental effects will promote the safe use of these chem-icals.


4 Existing situation

4.1 Turkish chemicals sectorThe Turkish chemical industry was built up during the 50ies and developed dur-ing the 60 and 70ies, being in 1998 the 4th major exporting sector among total in-dustrial export (following textile and clothing, iron and steel products and agricul-tural products). Based on the Under-secretariat of the prime ministry for foreign trade in Turkey, the value of chemical exports reached 1.7 billion EURO in 1998 or about 6.3% of the total exports in Turkey.

The Turkish Chemicals Industry is covering: petrochemicals, paints and pig-ments, soap and detergents, raw chemicals for textile, leather and polymer in-dustry, organic and inorganic chemicals, man-made fibers, crop chemicals, poly-mers and plastic, fertilizers, cosmetics, cements, industrial gases and others.

Taking into account the information provided by the Turkish Statistic Institute there are about 6,000 chemical manufacturing enterprises, most of them being small and medium size enterprises as shown by the Figure 1 below:

Figure 1: Small and medium size enterprises within chemical manufacturing enterprises

Turkish Chemical Industry had reached a 13% growth rate in 2005 exceeding the 8% growth rate of 2004 overcoming the negative growth outcomes in 2003 and

35

29

15

107

4

0

5

10

15

20

25

30

35

40

10-24 25-49 50-99 100-199 200-499 >500

Employer size

Enterprises %


2002. The chemical sector realized a Euros 14.5 billion imports and Euros 3 bil-lion exports with an annual Euros 21 billion overall turnover in 2005.

As indicated above, Turkish Chemicals Industry is active in the many production fields and a general view of the products as presented by the Turkish Statistical Institute is presented below:

Table 1: Overview of Turkish chemical products

Production 2004 (Billion TL) 1000 Euros (1) 2003 (Billion

TL)2002 (Billion

TL)Basic chemicals 977.827 543.237 873.996 756.651Fertiliser and nitro-gen compounds 934.441 519.134 838.974 693.974

Raw materials of synthetic rubber and plastics

2.493.299 1.385.166 1.765.751 1.508.268

Pesticide and other agriculture chemicals 243.378 135.210 221.090 237.342

Paints, varnishes, coating materials, seals and printing inks

1.367.371 759.651 1.127.292 932.776

Medical and pharma-ceutical chemicals 4.481.070 2.489.483 3.725.835 3.114.586

Soaps, detergents, cleaning chemicals, cosmetics and toilet products, perfumes

2.437.003 1.353.891 2.129.231 1.607.054

Other chemicals 1.222.049 678.916 908.567 712.192Synthetic fibres 1.500.571 833.651 1.156.614 1.008.919Total of Chemical industry 15.657.010 8.698.339 12.747.350 10.571.762

Total of Manufac-ture Industry 179.534.178 99.741.210 139.843.201 107.137.679

(1) (1euro = 1.800 TL)

4.2 Existing legal frameworkThe legal framework for dangerous substances and preparations consists mainly of the Environmental Protection Law no. 2872 of 9 August 1983 ,as amended and completed, the Dangerous Chemicals Regulation of 11 July 1993 (Official Gaz-ette No.21634/1993), with subsequent amendments, and the Communiqué on the Procedure for the Preparation of the Safety Data Sheet (Official Gazette no. 24692, 2002).

In April 2006 a new amendment was brought to Environment Law no. 2872 of 9 August 1983 by Law no. 5491 of 26 April 2006. Art. 2 of Law no. 5491 contains a definition of ‘dangerous chemicals’ (any chemical substance and product which has physical, chemical and/or biological adverse effects and thus lead to the impairment of ecological balance and the natural structure of human beings and other living beings). Art. 13, which deals both with dangerous chemicals and haz-ardous waste, establishes the basis for subsequent regulation of dangerous chem-icals, including classification, packaging, labelling or risk assessment, upon con-


sultation with other relevant stakeholders. It is also mentioned that the enterprises or institutions which placed dangerous chemicals on the market in violation of the regulation are responsible for the collection and disposal of materials containing dangerous chemicals.

As regarding the inspection, MoEF shall be authorized to inspect and, where ne-cessary, MoEF may assign this power to special provincial administrations, muni-cipalities with environmental inspection units, etc. (Art. 9). Law 5491 also pre-scribes administrative fines for non-observance of the dangerous chemicals re-gime (Art. 14), which shall be applied by MoEF or the institutions and authorities to which the inspection power is assigned by MoEF (Art. 16). Judicial penalties are foreseen (Art. 18) for providing incorrect and misleading information (pun-ished by sentence to prison). In conclusion, the Environmental (framework) Law does not contain contradictory provisions with the EU Chemicals Directives and allows secondary legislation to be adopted for further regulation.

The existing Dangerous Chemicals Regulation, amended in 2001, (Official Gazette no. 24379/2001) consists of 9 main parts as follows:· Aim, Scope, Legal Basis and Definitions;· Import Control of Chemical Substances: obligation to observe the Regu-

lation for those dealing with dangerous chemicals; prohibition to abandon dangerous chemicals as a pile to the environment; obligation of the man-ufacturer and importer to notify upon request of the Ministry harmful chemical substances and products or to submit additional information, etc;

· Responsibilities of Distributors and Enterprise Managers;· Rules for Labelling;· Packaging, Storage and Transport;· Duties of the Authority – (MoEF): evaluation of notifications, inspection

of manufacturers, importers & distributors, control of actual import and inspection of the market;

· Limitations (asbestos, PCB, PCT);

Other Provisions, among which Articles 44-45 refer to the Chemicals Safety Commission to be established by the Ministry of Environment and Forestry with the main purpose to ensure the implementation of the Regulation, but also to deal with updating required provisions by providing national and international inform-ation exchange and to inform opinion for satisfaction of deficiencies; in case of necessity to perform as an adviser; to deal with the to do with required studies concerning the accidents caused by chemical substances.

Annexes - Dangerous Substances List (Annex I), Information Form for the noti-fication by Manufacturers or Importer (Annex II), Danger Symbol and Signs for the Dangerous Substances and Preparations (Annex III), Packaging Classes (An-nex IV), Carcinogenic Substances List (Annex V), Risk Phrases and Safety Phrases for Labelling of the Dangerous Substances and Preparations (Annex VI), Classification related with Storage (Annex VII).

On the overall, the declared scope of the Regulation covers provisions, proced-ures and principles related to: determination, classification, labelling and pack-aging of dangerous chemicals; production, storage, transportation activities of dangerous chemicals; usage and placing on the market of dangerous chemicals and dangerous goods; importing and exporting of chemicals; dealing with danger-ous chemicals and dangerous goods; market surveillance and inspection of chem-icals and dangerous goods; and finally preparation and distribution of Safety Data Sheets.


The Dangerous Chemicals regulation transposes some definitions (Art. 4), Safety Data Sheet (Art. 12 and 22), symbols and indication of danger (Annex IV, nature of special risk attaching to dangerous substances (Annex VII), safety advice con-cerning dangerous chemical substances (Annex VII).

The Dangerous Chemicals Regulations transposes partially the objectives and scope (Art.), packaging (Art. 23-27), labelling (Art. 16-18 and 20), implementa-tion of labelling requirements (Art. 16-18 and 20), exemption from labelling re-quirements (Art. 16-18 and 20), and list of dangerous substances (Annex I).

The gaps in the Dangerous Chemicals Regulation compared to the Key Chemic-als Directives (Dangerous Substances Directive 67/548/EEC and Dangerous Chemicals Directive 99/45/EC) have been identified to be as follows: (a) defini-tions (new and existing substances, notification, EINECS, ELINCS); (b) some provisions on information exchange, risk assessment, classification, notification, confidentiality of data, assessment properties of substances, list of existing and new substances); (c) some annexes of Directive 67/548/EEC (Annex V, VI, VII, IX) all annexes of Directive 99/45/EC; (d) the dangerous chemicals list arranged according to Annex I of Directive 67/548/EEC.

Concerning the risk assessment (RA) for notified new substances, there is no Turkish Legislation transposing the requirements of the Commission’s Daughter Directive 93/67/EEC laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC.

There are four Implementing Regulations issued by the Ministry of Labour and Social Security require the employer to carry out a health risk assessment – ac-cording to in the workplaces where the workers are exposed to asbestos, chem-ical agents , carcinogen & mutagen substances, and explosive atmospheres, re-spectively:· Implementing Regulation on Health and Safety In Asbestos Related

Works – the RA will take into consideration the type and physical prop-erties of asbestos and the exposure level of workers;

· Implementing Regulation on the Protection of the Health and Safety Measures from the Risks Related to Chemical Agents at Work – the RA will consider: hazards and harms of the chemical agent to the health and safety; SDS provided by the supplier, manufacturer or importer; level, type, and duration of exposure; chemical agents amount, frequency of use, and conditions of use; occupational exposure limit values and bio-logical limit values mentioned in the annexes of the Implementing Regu-lation; the effect of preventive measures taken or to be taken; where available, previously made health surveillance results.

· Implementing Regulation for the Protection of Workers from the Risks Related to Exposure to Carcinogen and Mutagen Substances at Work – the RA will be based on working conditions, type and level of exposure of the workers to carcinogen and mutagen substances; and

· Implementing Regulation for the Protection Against Risks Of Ex-plosive Atmospheres – the RA will take into consideration: the possibil-ity of an explosive atmosphere forming and its permanency; the presence of sources of ignition including static electricity and the likelyhood to be-coming active and effective, the installations, substances used, processes and their possible interaction in the workplace, as well as the scale of the effect of a potential explosion.


It is mentioned in the Regulations presented above that the risk assessment will be carried out in compliance with MLSS’s Implementing Regulation for Occupa-tional Health and Safety. However, there is no procedure designed for the evalu-ation of risks to human health.

The MLSS’s Occupational Health and Safety Implementing Regulation - pub-lished in the Official Gazette no. 25311 of 9 December 2003 - introduces the measures to improve the occupational safety and health at the workplace, and the general principles concerning prevention of occupational risks, protection of health & safety, elimination of risk and accident factors, information and training of the workers and their representatives on occupational health and safety, con-sultation of the workers, working conditions of people that need special protec-tion due to their age, gender and special situations.

In Article 4, risk assessment is defined as the body of studies carried out with the purpose of determining the hazards present in the workplace or those coming from outside, the adverse effects these hazards may have on the workers, work-place or the work environment and the measures to be taken against these haz-ards. Also in the same article prevention is defined as comprising all the steps or measures taken or planned at all stages of work in the undertaking to prevent or reduce occupational risks. Women, children, elderly, disabled and other sensitive risk groups must be protected against the dangers that specifically affect them.

Obligations of employers related to the compliance with health and safety provi-sions are described in Article 6 of this Implementing Regulation. It is stated that the employer shall take the measures necessary for the safety and health protec-tion of workers, including prevention of occupational risks and provision of in-formation and training as well as provision of the necessary organization and means. The employer shall take necessary measures for avoiding risks, evaluating the risks which cannot be avoided, combating the risks at the source. The em-ployer, taking into account the nature of the activities at the workplace, shall eval-uate the risks to the safety and health of the workers, from the point of view of the choice of work equipment, the chemical substances or preparations used, and the fitting-out of workplaces. Subsequent to this evaluation, the preventive measures and the working and production methods implemented by the employer must as-sure an improvement in the level of protection ensured for workers with regard to health and safety.

Various other obligations of the employer are prescribed in this Implementing Regulation. In Sub-sections (1) and (2) of Section (a) of Article 9 it is stated that the employer along with the obligations above shall also carry out the following provisions:· The employer shall carry out an assessment of risks to the health and

safety of workers, including those groups of workers that may be affected particularly from those risks, at the workplace;

· Based on the results of the risk assessment, the employer will decide on the protective measures to be taken and the protective equipment to be used.

The Dangerous Chemicals Regulation (which is a by-law), as amended, trans-poses Article 27 of the Directive 67/548/EEC dealing with the Safety Data Sheets (SDS) and some provisions of SDS Directive 91/155/EEC defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations. The Communiqué on the Procedure for the Preparation of the Safety Data Sheet, 2002 (MoEF) was published to achieve full transposi-tion of Safety Data Sheet Directive 91/155/EEC. The Ministry of Health makes


reference to the legislation published by the Ministry of Environment and Forestry.

The existing legal framework in Turkey for the two key and two daughter direct-ives was outlined above and it was pointed out that there is still much to be done for reaching full transposition. The two extremes of the existing status are the full transposition of the SDS Directive 91/155/EEC and the inexistence of any legisla-tion on carrying out risk assessment – either by the Ministry of Environment and Forestry or other ministries, which will need to amend their legislation in order to regulate the obligation to carry out RA. In between there is the full range of EC requirements which will make object of the work carried out under the TeACH project. The result of this work will be materialised in the establishment of legal framework dedicated to the four main EU Chemicals Directives. Other legisla-tions will be in “stand-by”, depending on the details established in the future chemicals legal framework. Such examples are the Prior Informed Consent pro-cedure deriving from the Rotterdam Convention - on export and import of dan-gerous chemicals) or the restrictions to marketing and use of dangerous chemicals (Directive 76/769/EEC).

The Regulation on Environmental Inspection entered into force by being pub-lished in the Official Gazette in January 5, 2001. The purpose of this Regulation is to regulate the procedures and principles for environmental inspections for en-vironmental protection; from establishments of facilities, operation and until final disposal of waste produced in any stage of production.

The scope of the Regulation consists of the implementation issues related to en-vironmental inspection, qualities of environmental inspectors, and legal respons-ibilities of persons performing concerned activities, as well duties and authorities of inspecting bodies.

The competent authority to carry out environmental inspection is the MoEF through its Directorate General for Protection and Inspection of Environmental Pollution. The units authorised with inspection in the MoEF are as follows: · Chairmanship of Inspection Board, · Directorate General for Protection and Inspection of Environmental Pol-

lution, · Directorate General for Environmental Impact Assessment and Planning, · Provincial Directorates of Environment and Chairmanship of Special En-

vironmental Protection Organisation present in special environmental protection provinces according to the Article 25 of the Decree Law con-cerning the Establishment of the Special Environmental Protection Or-ganization No. 383.

For determining the enterprises to be inspected, the annual inspection program is prepared. In cases of accident, denunciations or complaints or when inspection out of the program deemed necessary by the MoEF, assignments are carried out separately from the annual inspection program.

Evaluation of compliance with the points requiring measurements in the environ-mental report is performed according to the results of measurement to be made by the private and public institutions and enterprises accredited.

Ceasing of activities of the organisations and enterprises failing to perform the legal liabilities stated in Article 10 of the Environmental Law is subjected to the provisions of Article 28 of the Environmental Impact Assessment Regulation published in the Official Journal dated 23.06.1997, No. 23028.


The staff of the MoEF in charge with the inspection prepares the inspection report in one month following the date of the completion of the inspection.

Other relevant legislation: The law relating to the preparation and implement-ation of the technical legislation on products no. 4703/2001 (published in the Official Gazette 24459/2001)

This law is a framework law which aims to lay down the principles and the pro-cedures for the placing on the market of the products, the obligations of the pro-ducers and the distributors; conformity assessment bodies; notified bodies; mar-ket surveillance and inspection; prohibition of the placing on the market of the products, withdrawal and destruction of the marketed products and the notifica-tions relating to these arrangements.

According to the article 4 of the law, technical regulations on the products shall be prepared by the public authorities. Also market surveillance and inspection shall be carried out in accordance with the procedures and principles laid down in the relevant technical regulations and/or this law and the regulations relating to the implementation of this law. The required administrative arrangements shall be determined by the Public authorities.

Based on art.14 of the above mentioned law, the Regulation relating to the market surveillance and inspection of the products no. 2001/3529 (published in the Official Gazette 24643/2002) has been published.

The objective of this Regulation is to lay down the principles and the procedures for the surveillance and inspection of the conformity of a product with the relev-ant technical regulation and with the requirements related to safety at the stage of placing on the market. This Regulation contains the provisions relating to:· the preparation of the technical regulations;· the principles concerning the conformity of the products with technical

regulations and product safety;· the obligations of the producers and the distributors at the stage of pla-

cing the product on the market;· the principles and the procedures for market surveillance and inspection;· the tasks and the obligations of the public authorities;· the establishment of the Coordinating Board on Market Surveillance and

Inspection; the tasks and working principles and procedures of the Board.

Law on consumer protection no. 4077 with its further amendments: the main objective of this law is to take measures aimed at protecting the health, safety and economic interests of consumers in line with the public good, building consumer awareness, indemnifying losses incurred by consumers and protecting them against environmental hazards; to promote consumer initiatives aimed at protect-ing consumer interests and to encourage volunteer organizations aimed at devis-ing consumer-related policies.

Article 18 mentions the Hazardous and Dangerous Goods and Services which re-quires information and warning measures to be provided, if the goods or services offered for the consumer's use endanger or harm a person's physical or mental health or the environment. The information and warning on this issue shall be ad-ded or written, in an easily visible and legible manner, on the goods or in the user's guide included, for the safe usage of such goods.

Also the provision emphasizes the Ministry of Industry’s obligation as the Min-istry is authorized to determine, together with pertinent ministries and other insti-tutions, which of the goods and services shall contain explanatory information


and warnings, and the form and place of such information and warnings, and an-nounce the same.

Goods or services offered to the consumer have to comply with the mandatory technical regulations, including the standards put into mandatory application by the pertinent ministries after being published in the Official Gazette.

The pertinent ministries shall implement or cause to be implemented inspections in accordance with such principles. The principles and guidelines relating to the inspection of goods and services shall be separately established and announced by each pertinent ministry.

A "Consumer Council" has been set up according to the provisions of this law un-der the coordination of the Ministry to search the measures necessary to deal with consumer problems, needs and interests, convey the views as to the measures to be taken to solve the problems in line with universal consumer rights, as well as the views as to the measures to be taken concerning the application of this Law, to pertinent authorities so that prompt action can be taken. Ministry of Environ-ment and Forestry is one of the participants of this Council.

4.3 Existing institutional frameworkThe existing structure of the main government institutions as well as relevant in-stitutions, which have roles in the management of chemicals are reviewed in this section. Only the Ministry of Environment and Forestry is responsible for indus-trial chemicals. However, some other ministries are responsible for labeling, packaging, market surveillance and inspection of other chemicals, for the same directives prevail. This section depicts the general institutional framework for the management of chemicals by in large.

4.4 Ministry of Environment and Forestry (MoEF)The Ministry of Environment was established in 1991. The act on the establish-ment of the Ministry of the Environment and Forestry adopted in May 2003 (Act no. 4856) has merged the two existing ministries, namely Ministry of Environ-ment and the Ministry of Forest. The new act defines the roles and responsibilities of the Ministry of the Environment and Forestry on the basis of the original acts on their establishment and reduces the overlaps in the respective responsibilities and implementation.

The MoEF has the responsibility for co-ordinating the Environment Chapter of EU legislation. The general mandates of the MoEF defined in the Organic Law No. 4856 that can be relevant to the management of chemicals are:· setting the environmental standards which are applicable in Turkey;· inspecting disposal of pollutants, which can be persistent in air, water and

soil;· issuing guidelines for emergency cases and risk management;· establishing laboratories for analysis, control and measurements;· ensuring collaboration and cooperation among the institutions and issuing

regulations for setting the principles of cooperation between the line min-istries

· monitoring and inspecting all kinds of activities, which have adverse im-pacts on environment

In the 2004 Regular Report on Turkey’s progress towards accession, it has been noted that “The establishment of an integrated Ministry of the Environment and Forestry is a positive step in relation to administrative capacity. However, it ap-


pears that this integration has not yet been effective in enhancing implementation. There are overlaps in competencies between different ministries and institutions, and therefore further efforts are needed. Special attention should be given to the administrative setup at different levels of the country under the newly proposed local administrative reform law. The overall planning, implementation and en-forcement of environmental legislation are a major concern. Significant efforts to-wards effective implementation of environmental legislation, especially recruit-ment and training of specialized staff and the purchase of equipment, are needed”1.The MoEF has 81 Provincial Directorates, one in each Province. The problem is the fact that not all Provinces have a functional MoEF office due to lack of the skilled and experienced staff2.

The organization chart of the Ministry of Environment and Forestry is shown in Figure 2. Regarding the management of chemicals, the General Directorate of En-vironmental Management has the main role, being responsible for all kinds of measurement, monitoring, analysis, inspections and control regarding environ-mental pollution, and inspection of activities which cause environmental pollution by chemicals, setting limitations and criteria for importing and exporting of chemicals, as well as identifying proper economic tools for management of chem-icals. Moreover setting targets, defining policies, establishing systems for man-agement of chemicals, preparing emergency plans for chemical plants, licensing the chemicals transport, detecting sites polluted by chemicals, taking necessary actions to clean up and initiate counter measures to minimize the impact on the environment and human health are among the responsibilities of this General Dir-ectorate. The organisational chart of the General Directorate is given in Figure 3.

The MoEF has the main responsibility for the co-ordination of chemicals man-agement and co-ordination of implementation of international conventions such as Prior Informed Consent Procedure (PIC) and Persistent Organic Pollutants (POPs) related with chemicals. The MoEF co-ordinates the activities and makes harmonisation studies under its responsibility in this field through its Chemicals Management Department, which is one of the units of the General Directorate of Environmental Management within the structure of MoEF. There are 17 staffs working in the Chemicals Management Department at present.

1 2004 Regular Report on Turkey’s progress towards accession, EC, 2004

2 Integrated Environmental Approximation Strategy for Turkey, Carl Bro, 2003


Figure 2: Organisational chart of the Ministry of Environment and Forestry

Documentnumber:

MINISTER

Main Services

UNDERSECRETARY

General Directorate Of Environmental

Management

General Directorate of Environmental Impact

Assessment

General Directorate of Forest Village

Relations

Department of Foreign Relations

and EU

General Directorate of Nature Protection and Natural Parks

Directorate of Private Office

Inspection Board

Counselor Of the Ministry

Advisory of Media and

Public Relations

DEPUTY UNDERSECRETARIES

Department of Education and

Publication

Consultation Services

Research Planning and Coordination Board

Legal Advisory

AuxiliaryServices

Department Of

Personnel

Department of Managerial and Financial Affairs

Related Institutions

General Directorate Of Forest

General Directorate of State

Meteorological Affairs

Information Department

Secretariat Of

Security

Authority for Special Protected Areas

Permanent Boards

Higher Environmental

Board

Local Environmental

Boards

Environment and Forestry Council

Central Hunting

Commission


There are 3 divisions under the Chemicals Management Department (see Figure no. 3).

There are 4 staffs working in the Division of Dangerous Chemicals Management. They are in charge of issuing import permits based on the Communiqué on Stand-ardization for Foreign Trade No. 2006/6. The permits are company specific, not substance specific. There are about 50 applications annually from importing com-panies. The substances or preparations, which are prohibited, to be placed on the market are listed in Annex III of the Communiqué. The chemicals, which are un-der control regarding the environmental protection are listed in Annex I/A and Annex I/B. For these chemicals, MoEF requires the companies to submit a copy of the label of the substance/preparation as well as its SDS Form; and issues an “importer recording document”. At the end of each year, the import companies return the “importer recording document” back to the MoEF about the identity of chemicals and their imported amounts together with the country of origin, com-pany, accompanied with actual import documents, including labels, SDS Forms, etc.

MoEF issues import certificate for importing the substances listed in Annex II. Division of Dangerous Chemicals Management keeps records of the imported chemicals and other relevant information about them.

Turkey has signed the Rotterdam Convention on the Prior Informed Consent Pro-cedure for Certain Hazardous Chemicals and Pesticides in International Trade but not has ratified it yet. Therefore, there is not any national legislation regarding PIC procedure. However, when there is an application from the EU Member States, the MoEF acts as the Competent Authority; and processes applications by getting opinions and consent of the relevant ministries.

The Division of Dangerous Chemicals Management has also responsibilities in controlling manufacturing and importing of asbestos; cooperating with the indus-trial stakeholders on “responsible care” issues; contributing in the process and representing the MoEF in the meetings of Market Surveillance and Inspection Commission coordinated by the Undersecreteriat of Foreign Trade; issueing the list of chemicals, which are restricted or prohibited.

Beside the above tasks, the Division of Dangerous Chemicals Management co-ordinates the work to be done related to UN, World Trade Organization, EU (spe-cifically on EC/304/2003 regarding Import and Export Procedures), EU Customs Union and OECD processes and procedures on management of chemicals as well as technical barriers to trade; follows up the Rotterdam Convention and Stock-holm Convention processes; participates in international meetings; represents Turkey in international fora.

There are 5 staffs working in the Division of Inventory and Risk Assessment. Since there is a gap regarding the mandate to be assigned to the Division of In-ventory and Risk Assessment regarding data collection and establishing and in-ventory could not be achieved by the Division until recently. The Division of In-ventory and Risk Assessment has responsibilities in risk assessment of existing chemicals. The Division is in the process of establishing the necessary system in order to implement the EU Regulation EC/793/93 on Risk Assessment of Exist-ing Chemical Substances. The Division of Inventory and Risk Assessment works on national Plan of Implementation Regarding the POPs Convention establishing the PCB and dioxins inventory in Turkey; follows up the international process to this end. The Division is also responsible for developing the inventory carried out under the TeACH Project.


Figure 3 – Organisational Chart of the General Directorate of Environmental Management

General Director

Department of

Measurement &

Inspection

Department of Water

& Soil

Management

Department of Marine & Coastal

Management

Department of

Chemicals

Department of

Waste Management

Department of

Air Management

Division ofEnvironmental

Inspection

Division of Env. Standards

Quality Assuranceand Education

Division of Sample and Laboratory

DeputyGeneral Director (3)

Division ofIndustrial Sourced

Air Pollution Control

Division of Heating and Motorized Vehicle Sourced

Air Pollution

Division of Noise

and Vibration Control

Division of Household

Waste

Division of Hazardous

Waste

Division of Medical and

Special Waste

Division of Water

Resources

Division of

Soil

Division of Treatment

Technologies

Division of DangerousChemicals

Management

Division of Inventory and Risk

Assessment

Division of Chemical and Industrial Accidents

Division of Marmara and

Straits

Division of Mediterranean& Aegean Sea

Division of

Black Sea

Division of Transboundary

Air Pollution Monitoring

Division of Natural Fuel and Material

Depending Control

Division of Waste

Inventory and Planning

Division of Packaging

Waste


The Division of Industrial and Chemical Accidents is working on issuing the rel-evant legislation, including the technical guidelines, regarding the implementation of SEVESO II Directive. The Division has already established the database for pre-notification system to implement the SEVESO II Directive. In this regard, The Division of Industrial and Chemical Accidents collaborates with the Ministry of Labor and Social Security.

Beside the above tasks, the Division of Industrial and Chemical Accidents co-ordinates the work to be done related to UNOCHA, World Maritime Organization processes and procedures, other requirements regarding the implementation of SEVESO I Directive and APELL; participates in international meetings; repres-ents Turkey in relevant international fora. The Division coordinates the prepara-tion of local emergency action plans, acts as focal point for notification of indus-trial and chemical accidents to be reported by the provincial governorships in compliance with the OECD format. There have been 6-7 accidents reported since 1999.

In addition to all these specific tasks, all three divisions are responsible, wherever is appropriate, for commenting on the draft national and international legislation; commenting on EIA Reports; contributing in relevant on-going projects within or outside the Ministry; participating in training programmes carried out in relevant fields in the EU accession process.

The Department of Measurement and Inspection under the same General Direct-orate carries out the inspection activities. There are 7 chief inspectors in this De-partment, who are in charge of planning the inspections and training the inspect-ors, who work in the provincial directorates. There are about 170 inspectors, who are trained in different subjects for inspection. However, there are no specifically trained inspectors in the field of chemicals. Because of that, in line with the an-nual inspection program, the Department of Measurement and Inspection invites an expert from the Chemicals Management Department whenever is appropriate. There are about 25 inspections programmed per year; some of them being in rela-tion to chemical industries.

According to the Organic Law of the MoEF, the Ministry is entitled to establish enterprises operating with revolving funds in relation to the mandates of the Min-istry. The tasks and duties of these enterprises, their revenues, operation and in-spection of them are regulated in b a By-law. The By-law on Enterprises with Re-volving Funds (dated 15 April 2004) include the following provisions, which may be the legal basis for the charging some fees for the activities carried out for the management of chemicals:· Without prejudice to the restrictions in the existing legislation, carrying

out measurements, analysis and tests in the laboratories affiliated to the Ministry and in relation to that issuing some reports and some documents by charging a fee

· Delivering application, permit, control and alike forms and documents, which are identified in the by-laws and in their annexes, by charging a fee

· Delivering course, conference, seminar, study, inventory, research, pro-ject preparation, project implementation, project development, operation and maintenance, protection, guidance, consultancy, management, opera-tion, etc. services.

4.5 Ministry of Health (MoH)The MoH is the main government body responsible for health sector policy mak-ing, implementation of national health strategies through programs and direct pro-


vision of health services. MoH is the major provider of primary and secondary health care, maternal health services, children’s and family planning services. It is essentially the only provider of preventive health services through an extensive network of health facilities (health centers and health posts) providing primary, secondary, and specialized in-patient and out-patient services.

The organisation and duties of the Ministry of Health (MoH) are described in the Decree Law No.181 dated 13.12.1983. The Ministry’s most related duties for the management of chemicals is defined as “Control and inspection of medicines/drugs and psychotropic substances at all phases of production and consumption, setting the principals of opening and operating of production and distribution places for pharmaceuticals and medicinal substances and preparations as well as inspecting these places”.

Ministry of Health is responsible for implementation of Directive 98/8/EC Pla-cing Biocidal Products on the Market. There are 23 groups of biocidals. Out of this, the Ministry of Health manages seven groups of them.

General Directorate of Primary Health Care is responsible for the management of five groups of biocidal products, which are used in the living environment of the human beings such as houses, work places, schools, parks, picnic areas etc. and its mandate to this end is described as “Inspecting toxic and narcotic substances, medicinal and vital preparations, all kinds of serums and vaccines used for human health as well as the places they are produced and/or marketed”. The Division of Pesticides and Vector Control under the Department (see Figure 3) of Environ-ment and Public Health undertakes implementation functions together with the re-lated laboratories and provincial directorates.

There is 8 staff working in this division. However, there are about 6,000 person-nel in charge of environmental health care; out of which 1800 are environmental health technicians working in the 81 provincial directorates of the MoH.

Figure 4: Organisational Chart of the General Directorate of Primary Health Care

The General Directorate of the Pharmaceuticals and Pharmacy is responsible for the disinfectants used for personal care and that are in direct contact with the hu-man body. This General Directorate is also responsible for the management and control of cosmetics and implementation of the Cosmetics Directive 76/768/EEC.

The General Directorate of Curative Services is responsible for the group of biocidals used for disinfecting the medical tools and equipment.

At the provincial level, provincial health directorates (for 81 provinces) are re-sponsible for administering health services provided by the MOH. The provincial

Division of Market

Surveillance and Inspection and Cleaning

Products

Division of Drinking and Utility Water

and Thermal Springs

Division of Pesticides and Vector Control

Division ofEnvironmental

ImpactAssessment

and Monitoring

Head of Environment and

Public Health Dept.


health directorates are accountable to provincial governors for administrative matters and to the MoH for technical matters. Directors of MoH hospitals report to the Director General of Curative Services, while Directors of Health Centers report to the Director General of Primary Health Care3.

The Ministry of Health established revolving funds for operating costs of the hos-pitals affiliated to the Ministry. While revolving funds are collected and kept in the facilities, MoH hospital managers are bound by guidelines from the MoH Dir-ectorate of Curative Services. Thus, as per the guidelines, a maximum of 50% of the funds can be used for topping up salaries, if the hospital has no other out-standing bills. The payment of salary supplements is expected to be based on per-formance. In the same context, MoH passed the legislation effective 1.11.2001 to introduce revolving funds for enhancing the operating budgets of primary care fa-cilities and 45 provinces received permission from the Ministry of Finance (MoF) to establish revolving funds for selected primary care. These revolving funds may give room for topping up some margin to the salaries of the technical staff.

The services pertaining to protect public health and conducting laboratory-based services are among the duties of MoH and are carried out by Refik Saydam Hy-giene Center, which is an affiliate institution of the Ministry of Health. The Cen-ter also acts as the “Reference Center” of the provincial public health laboratories offering services all over the country.

4.5.1 Refik Saydam Hygiene CenterRefik Saydam Hygiene Center is based in Ankara and has 7 regional laboratories throughout Turkey.

Refik Saydam Hygiene Center has the following mandates, which are relevant to the management of chemicals:

Controlling all kinds of medicines and cosmetics, which are manufactured within the country or imported to the country, carrying out research and laboratory ser-vices, analyzing pesticides and conducting efficacy tests;· Carrying out research and delivering laboratory services pertaining to the

environmental pollution;· Carrying out research and control services for toxic substances and pre-

parations;· Delivering refernce laboratoryservices.

There are 14 specialized technical units including Environmental Health Dir-ectorate, Toxicological Reasearch Directorate, Pharmaceuticals and Cosmet-ics Research Directorate.

Toxicological Reasearch Directorate is responsible for carrying out research on impacts of chemical substances and preparations on human health; as well as de-livering help desk services for medical doctors and other medical personnel, and for individuals to a certain extent.

Toxicological Reasearch Directorate has the following laboratories/sections:· Enthomology laboratory· Pesticide formulation laboratory· Pesticide residue laboratory· Analytical toxicology laboratory· National Toxicology Center

3 Turkey Health Report The Ministry of Health of Turkey-Refik Saydam Hygiene Center School of Public Health, February 2004, Ankara.


Environmental Health Directorate within the Refik saydam Hygiene Center has 9 laboratories specialized in air pollution, water quality, wastewater control, soil pollution control, environmental microbiology, noise control, cleaning products, occupational hygiene, disinfectant substances/preparations.

Pharmaceuticals and Cosmetics Research Directorate has specialised laboratories as well. The tests regarding the manufacturing and importing of cosmetics as well as market surveillance are carried out under the Cosmetics Preparations Control Laboratories.

4.6 Ministry of Labour and Social Security (MLSS)The Ministry of Labour and Social Security has a joint responsibility with the MoEF for adopting and implementing legislation aimed cotrolling of some certain chemicals both at the workplaces and at import4. MLSS is responsible for imple-menting Directive 83/477/EEC on the protection of workers from the risks related to exposure to asbestos at work and Directive 90/394/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work and Directive 1998/24/EC(5) on the protection of the health and safety of workers from the risk related to chemical agents at work and Directive 1999/92/EC on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres.

The General Directorate of Occupational Health and Safety (see organisational chart of the Ministry) is Security is responsible for all kinds of monitoring, in-spection, policy development, and planning issues regarding occupational health and safety.

The Occupational Health and Safety Centre, which is affiliated to the Ministry, has laboratory and inspection facilities as well as qualified staff. There is an EU-funded project for up-grading the capacity of the Centre.

4 www.calisma.gov.tr


Figure 5: Organisational Chart of the Ministry of Labour and Social Security

Minister of Labour and

Social Security

General

Directorate of Labour

Department of EU

Coordination

Department of

Research and Planning

GD ofOccupational Health and

Safety

GD ofForeign Affair and Abroad

Workers

Undersecretary

Deputy Undersecretary

Legal Advisor

Secretary of Defense

ISGUM

Department of Social Security

Authority

GM of Turkish Works

Institution

GM of Social Insurance of

Tradesmen and Independent Businessmen

Social Insurances Institution

Regional Directorates

Abroad Attachés

Training and Research Center

Administrativeand

Financial Matters Dept.

Department of IT

Department of Personnel

Works

Workers SolidarityFund - Ereğli

Head of Inspection Committee

Manager for Media and PR

Advisors

Head of Works Inspection

Commission

Cabinet of the Minister


4.6.1 Occupational Health and Safety Center (ISGUM)The mandate of the ISGUM is carrying out studies and researches for developing norms and standards regarding occupational health and safety, updating these norms and standards in parallel to the technological developments, identifying the vocational education needs and suggesting for the curricula of these education as well as issuing publications. In order to accomplish these mandates, ISGUM con-ducts surveys and researches, works on adjusting the work environment and pro-duction processes with respect to the skills of the human beings, delivers on-the-job training and consultancy services.

There are 3 main technical sections in the Center:· Labor’s Health Section· Occupational Hygiene Section· Occupational Safety Section

ISGUM has one central laboratory in Ankara and 5 regional laboratories in Istan-bul, Izmir, Adana, Kocaeli and Zonguldak.

The Project for “Upgrading Occupational Health and Safety in Turkey” funded by EU was completed in January 2006. Improvement of laboratories constituted one of the main activities of the Project. In this frame, Kocaeli and Ankara have been chosen as pilot regions for laboratory support in the occupational health and safety.

4.7 Ministry of Agriculture and Rural Affairs (MARA)The most relevant but not very specific duties of the Ministry (according to the Government Decree no. 441 in Force of Law) regarding the management of chemicals are as follows: · To make research, surveys, plans, programs and projects, or have them

made, on the production, consumption and input as well as the protection and improvement of soil, water, plants and animals in accordance with the requirements of development and growing demands;

· To ensure the improvement of livestock and aquatic products.

The ministry performs its related duties through its peripheral organisation. The peripheral organisation of the ministry consists of research institutes, provincial and district directorates, agricultural farms and supervision units.

The General Directorate of Protection and Control within the Ministry of Agriculture and Rural Affairs is in charge of control and management of pla-cing on the market of plant protection products as well as 2 groups of biocidal products.

The areas for which the General Directorate of Protection and Control is respons-ible are protecting the resources of plants, animals and fisheries as well as the re-lated products, ensuring their integrity and contributing to delivery of agricultural inputs such as feedstuffs, veterinary drugs and pesticides, animal vaccines and seeds to the producers in a healthy manner. The General Directorate performs all these activities and responsibilities through the Provincial and District Director-ates, Food Control Laboratories, Research Institutes, and Veterinary and Agricul-tural Quarantine Directorates. There are also Provincial Control Laboratory Dir-ectorates in 39 provinces. They serve for water quality control as well as fertilizer use advisers.


Figure 6: Organisational Chart of the General Directorate of Protection and Control within MARA

4.7.1 Agricultural Pest Control Central Research Institute (ZMMAE)Agricultural Pest Control Central Research Institute based in Ankara is respons-ible for research, delivering laboratory services, issuing publications and conduct-ing training programs on agricultural pest control. Among others, the Institute has the following duties:· carrying out studies on pesticide residues in agricultural products, water

and soil; · carrying out research on impacts of pesticides on environment and human

health;· carrying out physical and chemical analysis of pesticides, which are sub-

ject to licensing, and compliance checks of the samples of these prepara-tions collected from the market;

· analysing the dangerous impurities in the formulations and advising on ingredients, which are not dangerous for human health;

· participating in the Pesticide Licensing Committee.

There are 9 sections in the institute one of them being Pesticides Section. There are 3 laboratories under this section:· Physical Analysis Laboratory

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General Director

Department of

Coordination Services

Depart. of Environment

and Disasters

Departmentof

Aqua-products

Department of

Medicaments & Equipment

Department of

Public Health

Divisionsof Feedstuff Control

DeputyGeneral Director (5)

Departmentof

LivestockHealth

DepartmentOf

LivestockQuarantina

Division of Plant

Protection Products

Department of Veterinary

Medicaments

Dept. of Pesticide and Equipment

Control

http://www.kkgm.gov.tr/birim/Hayv_Sagl/Gorev_Hayv_Sagl.htm


· Chemical Analysis Laboratory· Residue Laboratory

There are about 135 persons working in the Institute, 57 of them are technical staff.

Beside the Central Research Institute, there are 3 pesticide research institutes in Adana, Diyarbakır and Bornova (Izmir).

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

Tobacco, Tobacco Products and Alcoholic Beverages Market Regulatory Author-ity was established in 2002 in order to ensure the regulation of the tobacco, alco-hol and alcoholic beverages market. All kind of regulation, implementation and inspection as well as enforcement regarding the manufacturing, importing and distribution of methyl alcohol and ethyl alcohol are under the responsibility og TAPDK.

Communiqué on the Market Supply of Ethyl Alcohol regulates the ethyl alcohol to be put on the market, either for producing alcoholic beverages or for other in-dustrial uses. The purpose of the communiqué is to set the procedures and prin-ciples governing safe and purposeful storage, denaturation, distribution and pla-cing ethyl alcohol produced or imported on the market.

4.9 Other pertinent stakeholdersThe government institutions described below have some indirect roles in the man-agement of chemicals, like macro economic planning, public investment pro-gramming, export, import regulations and controls.

4.9.1 State Planning OrganisationThe Under-secretariat for the State Planning Organisation (DPT) affiliated to the Prime Ministry’s Office is a consultative body for the Government and drafts na-tional development plans and annual investment programmes (general govern-ment investment budget), to be endorsed by the parliament. The 9th Development Plan (2007-2013) has been recently issued.

The DPT also prepares sectoral plans including environment and chemicals man-ufacturing sectors with due emphasis on macro-economic policy issues. There policies are instructive for the public institutions, and guiding for the private com-panies.

DPT approves projects requiring large amounts of public financing (over USD5 million) or foreign loans.

The following General Directorates of the DPT are relevant in relation to EU heavy-cost investment directives:· General Directorate of Social Planning and Coordination· General Directorate of Economic Planning and Coordination· General Directorate of Regional Development and Structural Adjustment· General Directorate of EU Relations· General Directorate of Social Planning and Coordination is responsible

for, including others, overall environmental policies while General Dir-ectorate of Economic Planning and Coordination is responsible for draft-ing the policies regarding all manufacturing sectors including chemicals.


4.9.2 Undersecreteriat for Foreign TradeUnder-secrateriat for Foreign Trade was an integral part of the Treasury for 11 years and the title of the institution was the Under-secretariat for Treasury and Foreign Trade until 1994. The mandates of the Under-secretariat for Foreign Trade are:· assisting in developing foreign policies· regulating exports, incentives for exports, imports, contracting services in

abroad, bi-lateral and multi-lateral trade and economic relations· implementing all these, monitoring and improving implementations,

The Under-secretariat coordinates the implementation of The Law Relating to the Preparation and Implementation of the Technical Legislation on the Products (Law No. 4703) among the Ministry of Environment and Forestry, Ministry of Agriculture and Rural Affairs, and Ministry of Health. The objective of the Law is to lay down the principles and the procedures for the placing on the market of the products, conformity assessment, market surveillance and inspection and the notifications relating to these arrangements. The Law covers the conditions of placing on the market of the products; the obligations of the producers and the distributors; conformity assessment bodies; notified bodies; market surveillance and inspection; prohibition of the placing on the market of the products, with-drawal and destruction of the marketed products and the notifications relating to these arrangements. Law No 4703 ensures that the new products to be placed on the market shall be in conformity with the relevant technical regulations. There is a Market Surveillance and Inspection Coordination Council established in com-pliance with the By-law on Market Surveillance and Inspection dated 11 January 2002. The council comprises of 13 members including the –Under-secretariat for Foreign Trade, Ministry of Environment and Forestry, Ministry of Health, Min-istry of Agriculture and Rural Affairs, Ministry of Labour and Social Security, Ministry of Industry and Trade.

The Cabinet Decision of 2005/9454 identifies technical organization in foreign trade, standards, conformity assessment and authorized institutions for inspec-tions procedures and principles of implementation.

The organizational chart of the Under-secretariat for Foreign Trade is in Figure 7 below.


Figure 7: Organisational Chart of the Under-secretariat for Foreign Trade

The Under-secretariat of Foreign Trade prepared the "Ministerial Decree on the Regime of Technical Regulations and Standardization for Foreign Trade" and its supplementary legislation with the aim of providing transparency in the imple-mentations, assembling all the dispersed regulations regarding standardization policies in Turkey and establishing a legal base for the harmonization of Turkish legislation with the Community’s. The Regime mainly consists of the Ministerial Decree, a Regulation and 8 Communiqués. The General Directorate of Standard-isation in Foreign Trade amends the Regulation and the Communiqués every year. The following communiqués include standardization of the control of im-porting of chemicals, which are under the responsibility of Ministry of Environ-ment and Forestry, Ministry of Health and Ministry of Agriculture and Foreign Affairs. · Communiqué of Standardization for Foreign Trade No. (2005/4) regard-

ing importation of certain goods such as narcotics and of some kind of chemicals is prohibited by this Communiqué.

· Communiqué of Standardization for Foreign Trade No. (2005/23), re-garding the importation cosmetic products. The importers are subject to submitting notifications to Ministry of Health according to Cosmetic Law and Regulations of Cosmetics.

· Communiqué of Standardization psychotropic substances, cleaning agents, chemicals, pharmaceutical products, medicines, detergents, etc. are subject to the control of Ministry of Health;

· Communiqué of Standardization for Foreign Trade No. (2005/5) regard-ing the importation of certain goods such as foodstuffs, agricultural and animal products and veterinary products is subject to the control of Min-istry of Agriculture and Rural Affairs.

· Communiqué of Standardization for Foreign Trade No. (2005/6) regard-ing the importation of ozone depleting substances and chemicals, which are listed under the Annexes of this Communiqué, and within the scope of Chemical Substances Importation Certificate, are subject to the control of Ministry of Environment and Forestry. In addition, import for Foreign Trade No. (2005/32), for the importation of detergent

Undersecretary

General Directorate of Exports

General Directorate of EU Affairs

Gen. Dir.Standardizat

ion in Foreign Trade

General Directorate

of Free Trade Zones

General Directorate of Agreements

General Directorate

of Imports

DeputyUndersecretaries (3)

Gen. Dir. of Economic Research

and Evaluation


products. The importers should submit notifications to Ministry of Health.

The controls are carried out by the inspection units called as “Inspectorates of Standardization for Foreign Trade”, within the 8 Regional Directorates (Marmara, Western Anatolia, South Anatolia, Eastern Black Sea, Western Black Sea, South Eastern Anatolia, Central Anatolia and Eastern Anatolia) working under the UFT.

The importation of some products including some chemicals are regulated by the General Directorate of Imports with the following communiqués, which are up-dated every year:· Communiqué No. 2006/11 on some explosives· Communiqué No. 2006/12 on solvents and some petroleum products· Communiqué No. 2006/13 on some products, which effect occupational

health and safety· Communiqué No. 2006/14 on ozone depleting substances· Communiqué No. 2006/15 on some dyestuff· Communiqué No. 2006/16 on fertilizers· Communiqué No. 2006/17 on chemical substances, which are listed in

the annex of the Chemical Weapons Convention

The General Directorate of Exports, regulates the exportation of the goods includ-ing some chemicals. The relevant communiqués are listed below: · According to the Communique of Export No. (96/31), goods whose ex-

portation is proinhibited by laws, decrees and international agreements and dependent on prior authorization of certain establishments are listed in the annexes of this Communique. This list also contains certain chem-icals.

· According to the Communique of Export No. (96/31), goods whose ex-portation is proinhibited by laws, decrees and international agreements and dependent on prior authorization of certain establishments are listed in the annexes of this Communique which also includes certain chemic-als.

· According to the Communique of Export No. (2003/12), Concerning the Control of the Export of Dual-use and Sensitive Goods, the export of dual-use and sensitive goods capable of utilization for both civilian and military purposes, and which are subject to control in accordance with the international arrangements and regimes which our country is a party to and which have been introduced in order to control the export of materi-als and technologies that can be used in the development of mass destruc-tion weapons is regulated. This Communique also includes certain chem-icals.

· According to the Communique of Export No. (2004/13), proced-ures and principles for the export of ozone depleting substances are regulated.

· According to the Communique of Export No. (2002/12), procedures and principles for the export of substances listed in the annexes to the Con-vention on the Control of Chemical Weapons are regulated.

The duties of the General Directorate of Economic Research and Evaluation in-clude establishing, managing and operating a Foreign Trade Information Center in order to ensure that information is readily accessible by the users.


4.9.3 Under-secretariat for CustomsThe Undersecretariat for Customs is affiliated to the Prime Ministry. According to its organic law, the principles for the establishment and functions of the Cus-toms Undersecretariat is to organize and coordinate the customs and customs en-forcement services and to combat smuggling.

The duties of the Customs Undersecretariat are as follows: · to contribute to the preparation of customs policy, · to assist to apply the provisions of the Customs Law and other related le-

gislation and international agreements, · to assist to determine the customs tariff rates and to collect and to control

the customs taxes and other revenues and funds, · to control and inspect goods and vehicles and to take necessary precau-

tions to carry out the procedures effectively and swiftly, · to compile the statistical data concerning the customs, · to assist to protect the goods and vehicles subject to customs control. and

to control whether they comply with the certain norms and standards, · to prevent, inspect and investigate the smuggling in the customs gates and

“laissez-passer”1 gates on territorial borders and customs seaports and airports and free trade zones and various warehouses and inland customs territories,

· to prevent and prosecute and investigate the smuggling, if necessary, in collaboration with the other related organizations in other locations,

· to pursue studies on the Under-secretariat services and to make decisions and to coordinate national and international activities,

· to execute duties assigned to the Under-secretariat with various laws, · to train professionals to fulfil their tasks duly and to organize the relevant

studies, · to pursue and evaluate and investigate and control whether the above-

mentioned functions are fulfilled properly.The organigramme of the Under-secretariat for Customs is in Figure 8.

Figure 8: Organisational Chart of the Under-secretariat for Customs

Imported goods are subject to the customs tax and VAT; funds are collected on some goods such as agricultural products.


Turkey is in a Customs Union with the EC since 1996, the application of which has been extended to the ten new members by a Decree dated 2 October 2004. Subsequently, products circulate freely with all EU members. Indeed, latest for-eign trade figures confirm that Turkey has trade relations with all EU members within the framework of the Turkey-EC Customs Union. Turkish Customs legis-lation was adapted to EU legislation so as to enable two or more countries to an-nul the customs taxes mutually and impose them on third countries due to the es-tablishment of the Customs Union.


5 Transposition and implementation plan

5.1 Transposition planThe transposition of the EU chemicals legislation is relatively on good level, compared to other sectors. European chemical legislation is partially implemented by the existing Dangerous Chemicals Regulation. Nevertheless, full transposition and implementation of the chemicals legislation have to be achieved by the date of accession.

Taking into account the current legal and institutional framework, as well as the weaknesses of the implementation process (less coordination and cooperation among the relevant stakeholders, duplication and overlapping in term of respons-ibilities’ allocation, etc.), the amendment and completion of the existing Danger-ous Chemicals Regulation is a pre-condition for achieving full transposition.

The milestones for the actions concerning the transposition of the chemicals le-gislation as focus on the 4 key EU Directives subject of the current strategy in-clude:

Table 2: Transposition milestone

Milestones Responsible Deadlines

1. Chemicals ActExecutive regulations

MoEF, January 2007May 2007

2. Procedures for notification, classi-fication, packaging and labelling are adopted by

a) Chemicals actb) Executive regulations

MoEF February 2007May 2007

3. Procedure for risk assessment is in place

MoEF March 2007

4. Procedure for Data Safety Sheets is in place

MoEF done

5. Monitoring and inspection proced-ures are in place

MoEF, MoH May 2007

In the table presented above, the legal framework transposing the chemicals legis-lation include the generic terminology refers to “chemical act” or “executive reg-ulations” without detailing the level of the legislation to e adopted.

Two different options derive from the legal gap analysis performed in order to identify the status of the transposition process:· Option 1: which requires the adoption of a chemical framework law, set-

ting up the framework for the development of the secondary legislation to


ensure full transposition of environmental chemicals acquis, as well as designating the competent authority/es responsible for the implementa-tion of the relevant legislation;

· Option 2: amending the current Dangerous Chemical Regulation to en-sure full transposition, including the amendment and completion of the special laws on the establishment of certain governmental bodies, in or-der to clarify/assign relevant responsibilities to certain competent author-ity/es (e.g. to designate the Ministry of Health as competent authority for providing risk assessment of chemical substances and preparations from the view of their effects on human health, drafting risk limiting strategies based on the risk assessment results, etc.).

The selection of the most appropriate option depends on the selection of the rel-evant institutional framework design to implement the relevant chemicals legisla-tion which is presented in another section concerning the implementation plan.

It must be noted that currently the MoEF is the beneficiary of the EU financed project “Technical Assistance in the field of chemicals” which aim to support the ministry in transposing the chemicals legislation and preparing the relevant im-plementation procedures, so the deadlines foreseen by the above transposition table are link to the project implementation timetable.

5.2 Implementation PlanFor the proper implementation of the chemicals legislation, Turkey has to set up the institutional framework and to make it fully operational by the date of acces-sion. The detailed analysis of the current institutional framework performed as part of the current strategy identifies the main weaknesses and strength of the ex-isting system, providing recommendations for institutional strengthening which have to address the full regulatory cycle as presented in Figure 9 below:

Figure 9: Regulatory cycle

Legislation

Policy planning

Objectives

Assessment & feedback

Enforcement

Permitting

Compliance control

Compliance promotion

Legislation

Policy planning

Objectives

Assessment & feedback

Enforcement

Permitting

Compliance control

Compliance promotion

EU requirements not transposed

Notification proceduresLack of trained staff

No inspection & enforcementNo monitoring

No Information disseminationTraining required

Lack of trained staffGuidelines required

No Monitoring systemLack of staffTraining


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

The current strategy presents different options regarding the institutional frame-work to be set up in order to allow an effective implementation and enforcement system, based on the following assumptions derive from the assessment of the current policies, programmes and projects implemented or on-going within the relevant stakeholders:· MoEF will be the Turkish Competent Authority;· MoEF committed itself for establishing the National Environment

Agency (NEA) and drafting the Organic Law of it.· The National Environment Agency (NEA)5 will be established to under-

take monitoring, inspection and enforcement functions of the Ministry of Environment and Forestry.

· The Turkish Chemicals Bureau/Agency/Department, which will be re-sponsible for carrying out technical tasks regarding the management of chemicals, will thus be subordinated to the MoEF;

· MoH will establish a similar Biocidal Products Bureau/Agency/Depart-ment;

· Effective working relations between different institutions will be estab-lished through a Committee for policy development in chemicals man-agement and international relations.

· The Chemicals Advisory Committee (CAC) will be established to work with the MoEF as advisory body.

· Close working relations with the other institutions will be developed for risk assessment, risk management and import/export of the chemical sub-stances and preparations.

· Risk assessment units/expertise will be developed in the specialised insti-tutions of the pertinent ministries.

· Monitoring and inspection activities will be carried out by the regional/provincial/ sub-provincial directorates of the pertinent institutions.

The following options were proposed and analysed as part of the strategy:1. MoEF-option: The Turkish Chemicals Agency (TCA) is an integral part

of the MoEF as a technical unit;2. TCA-option: A separate TCA is established under the MoEF;3. NEA-option: The TCA is established as part of the National Environment

Agency, now being established by the MoEF;4. TCBPA-option: The TCA will also be responsible for handling Biocidal

Products (similar to the structure in Slovakia), still under the MoEF, thus becoming the TCBPA;

5 Regardless of the chemicals management institutional framework, National Environ-mental Agency has already been intended to be established and initiated by the staff of the Ministry. NEA will undertake the monitoring, inspection and enforcement functions of the Ministry of Environment and Forestry. A new special law is essential for the estab-lishment of NEA. The special law for NEA would be an organic law which designates NEA as the competent authority and sets the duties and responsibilities of NEA moreover, it must reflect the close cooperation and working principles of NEA with the other relevant ministries. Besides, the new law would involve incorporating the activities of the concerned parties with NEA. NEA would be an institute of MoEF as Specially Pro-tected Areas Institution or Turkish State Meteorological Service. On the other hand, the Organic Law of MoEF would be amended to subsume NEA. However, NEA will be es-tablished with the personnel and equipment of MoEF and will not be able to deal with the requirements of EU law so, the financial resources of NEA should be defined in law.


The above options will be explained further in the next sections.

5.2.1.1 Option 1: The MoEF-optionFigure 10: Organisational scheme for the MoEF option

In this option the Chemicals Management Department of the Ministry of Environ-ment and Forestry will be expanded to cover a so-called “technical unit” with ad-dition of some technical divisions to extend the tasks of the Department. These divisions will deal with notifications, monitoring and reporting, risk assessment (if required) and information dissemination, including helpdesk function for min-isterial, regional and provincial staff, including staff of other Ministries. This will involve an important increase of staff of this Department.

The primary tasks of the Technical Unit will be:· Prepare and update regularly the inventory of chemical substances;· Follow and take care of the notification of new chemical substances;· The collection of data on chemical substances, maintain the databases on

chemical substances and the related software including the website;· The initial risk assessment of chemical substances for human health and

the environment;· Information exchange on chemical substances to other relevant institu-

tions like the Biocidals Products Office, regional and local authorities;· Take care of the secretarial work of the Chemicals Advisory Committee.

The organisation of the Technical Unit can be as follows:

MoH MARAMLSSMoEF

Chemicals Management Department

Div. of Planning and Regulating

Div. of Notification and Risk Assessment

Div. of Inventory & Information

Div. of industrial accidents and risk management

Chemicals Advisory Committee

Provincial/Regional Offices of MoEF, MoH, MLSS, MARA

National Environment Agency

Regional Environment Agencies

Biocidals

Bureau/Agency/Dept

ZMMAER.S. Hygiene Inst.ISGUM


Figure 11: Organisation of Technical Unit

Each section of the TU will be responsible for the tasks assigned to this section and as mentioned above.

Department of Chemicals Management

Division of Notification and Risk Assessment

Div. of Inventory & Information

Div. of industrial

accidents and risk

management

Div. of Planning and Regulation

TECHNICAL UNIT


5.2.1.2 Option 2: The TCA-option

The Turkish Chemicals Agency (TCA) option is in fact very similar to the option described above. The main difference now is that the TCA is not directly part of the MoEF but is a separate organisation, subordinated directly to the MoEF (sim-ilar to Authority for Protection of Special Areas)Figure 12: Organisational scheme of the TCA-option

The tasks and responsibilities of the organisations and institutions in the TCA-op-tion are identical to the tasks and responsibilities in the MoEF-option. The rela-tionship between MoEF and the TCA will be slightly different. Chemicals Man-agement Department within the MoEF will undertake only the planning and regu-lating functions including international relations. TCA will carry out other tech-nical functions, similar to the technical unit as in the first case.

5.2.1.3 Option 3: The NEA-option:

The NEA option has been prepared to show the possibility of integration of the executive agencies of the MoEF. MoEF is already establishing an important exec-utive organisation responsible for implementing a wide range of environmental legislation in Turkey, including the IPPC, Seveso, Water and Waste legislations.

MoH MARAMLSSMoEF

Chemicals Management Department Chemicals Advisory Committee


National Environment Agency


Biocidals

Bureau/Agency/Dept


TurkishChemicals

Agency


This provides a clear opportunity to integrate the Turkish Chemicals Agency in this NEA to improve and strengthen the co-ordination and co-operation at the im-plementation and executive level.Figure 13: Organisational scheme for the NEA option.

The tasks and responsibilities of the different government institutions presented in the above scheme are very similar to the tasks and responsibilities as described under the MoEF option.

The Chemicals Management Department will be responsible for planning and set-ting standards, issuing legislation as well as international relations. There will be Chemicals Department established in NEA to carry out other technical functions similar to the technical unit suggested in the first case. The relationship between MoEF and Chemicals Department of NEA will also depend on how the relation-ship between NEA and MoEF will be developed. It is clear that now the manage-ment of NEA will also have an important role in managing the Chemicals Depart-ment.

5.2.1.4 Option 4: The TCBPA-option

The TCBPA-option can be considered as an extension e.g. further integration of the implementation organisations presented in the TCA-option. TCBA stands for Turkish Chemicals and Biocidal Products Agency.

This already clearly shows the main intention of this option: establish a joint Agency responsible for implementing the governmental tasks following from the

MARAMLSSMoEFChem. Man.

Dept.



National Environment

Agency

Chemicals Department


Biocidals

Bureau/Agency/Dept.


MoH


Chemicals legislation of MoEF and from the Biocidal products legislation imple-mented by MoH. This corresponds with the approach followed in Slovakia.Figure 14: Organisational scheme of the TCBPA-option

The tasks and responsibilities of the institutions indicated in the above scheme will be the same as the tasks and responsibilities described under the MoEF-op-tion.

However, now MoH will be the appeal body for decisions taken by the TCBPA directly related to human health.

TCBPA will be responsible for notification procedures for the industrial chemic-als as well as registration procedures for biocidals. Both environmental and health risk assessments will be carried out by the TCBPA. The inventory database man-aged by the TCBPA will cover not only the industrial chemicals but also the biocidal products in collaboration with the Ministry of Labour and Social Secur-ity for occupational health risk assessment.

Important issue for this option will be to elaborate the co-operation procedure between MoH and MoEF.

5.2.1.5 Roles and responsibilities allocated to the competent au-thority and relevant stakeholders

Chemicals Advisory Committee (CAC): the establishment of this committee is a pre-conditions for all options presented above; the committee will be set up as an advisory body aim to promote a better understanding between stakeholders of

MoH MARAMLSSMoEF



National Environment

Agency


Turkish Chemicals and Biocidal Products Agency (TCBPA)

ZMMAER.S. Hygiene Inst. ISGUM


the concerns which people have about chemicals in the environment. By provid-ing advice to the Government, it will ensure that these concerns are fully reflected in the development of Turkey policy on chemicals and the environment. Its scope will be the impact which the production and use of industrial chemicals has on the environment, and on human health through environmental exposure. As a general overview, the main tasks of the Chemicals Advisory Committee (CAC) should be summarized as following:· Exchange information between the different governmental institutions;· Explore the views of many sectors of society who work with or are con-

cern about industrial chemicals, promoting a better understanding of en-vironmental concerns and the complexity of managing them in a cost-ef-fective and socially beneficial way, by developing a wider consultation programme;

· Advising the competent authority on establishing criteria for rapid identi-fication of those chemicals of concern which requires a risk management strategy, taking account of the key properties of environmental persist-ence, tendency to bioaccumulate and toxicity;

· Advise the competent authority on risk management strategies;· Follow the activities of the Technical Unit and provide guidance e.g. ap-

prove the yearly programme of the Technical Unit as well as evaluate its performance;

· Set priorities in the activities of the Technical Unit;· Develop recommendations to improve the functioning of the TU and im-

prove the co-ordination and co-operation with other institutions;· Etc.

The Chemicals Advisory Committee (CAC) will be chaired by the competent au-thority i.e. the MoEF and the relevant Chemicals Management Directorate/De-partment/Technical Unit will provide a secretariat to act in a facilitating role. The CAC will be composed of representatives from the following Government institu-tions:· MoEF who will chair the committee and have one additional representat-

ive in the committee from the Chemicals Management Department;· The TU of MoEF, acting as the secretariat of the CAC;· Ministry of Health;· Ministry of Labour and Social Security;· Ministry of Agriculture and Rural Affairs· Under-secretariat for Foreign Trade;· Under-secretariat for Customs;· Ministry of Industry and Trade;· Turkish Chemical Manufacturers Association;· Scientific experts (for example from the Toxicology Association);· Other participants (ad-hoc members) to be decided/ discussed.

The CAC will meet regularly at the premises of the MoEF. In the beginning the CAC will meet quarterly. The MoEF will prepare comments and a final position on all conclusions and recommendations issued by the CAC.

The members of the CAC will have access to high quality scientific, technical, economic and other guidance. This will cover a range of environmental, health and other issues which fall within the responsibility of many Government depart-ments. There is also likely to be a need for a technical panel of experts to provide advice to the CAC on ecotoxicology, risk assessment and criteria for prioritisa-tion.


Ministry of Environment and Forestry: as the Competent Authority (CA) in the field of chemicals management will be:· provides and co-ordinates all activities in the field of chemicals manage-

ment in co-operation with the Ministry of Health, the Ministry of Labour and Social Security and the Ministry of Agriculture and Rural Affairs in the field of free movement of chemical substances and chemical prepara-tions;

· after receiving opinions of the Ministry of Health, the Ministry of Labour and Social Security and the Ministry of Agriculture and Rural Affairs is-sues a preliminary consent to import the certain dangerous chemical sub-stances and certain dangerous chemical preparations subject to the PIC procedure;

· verifies the possibility to export the certain dangerous chemical sub-stances and certain dangerous chemical preparations restricted due to their effects on environment and human health;

· manages and assesses the flow of information linked to the placing on the market of a new chemical substances;

· Design procedures for compliance programmes, notification, inspection and verification, safety requirements;

· evaluates the risk of dangerous substances based on the information provided by manufacturers and importers from the view of their effects on the environment;

· based on the risk assessment, restricts or prohibits the placing on the mar-ket of certain dangerous chemical substances and certain dangerous chemical preparations;

· sets up a data collection system and publishes statistical information· keeps the records of entrepreneurs importing or exporting the certain dan-

gerous chemical substance and certain dangerous chemical preparations, and the List of Dangerous Chemical Substances and Dangerous Chemical Preparations;

· evaluates data supplied by manufacturers and importers on chemical sub-stances

· permits labelling of the chemical substances and the chemical prepara-tions in exceptional cases;

· creates permanent forum with the chemical industry sector to allow ef-fective exchange of information to take place and for the preparation of proposals for classification of existing substances.

· publishes in the Official Journal the Lists of Chemical Substances and Chemical Preparations, reviewing and amending them;

· publicises requirements to relevant manufacturers, importers, exporters, etc

· develops the necessary data bases to be consulted by manufacturers and importers to avoid unnecessary duplication of testing especially for what involves animal testing.

· conducts effective custom and internal controls, monitoring and inspec-tion activities to avoid illegal import and marketing of non-notified chem-icals from third countries.

· ensures that manufactures of controlled substances reduce and cease pro-duction

· introduces appropriate legal and administrative sanctions to deal with noncompliance by industries and importers.

· acts as body of appeal for decisions made by the Turkish Chemicals Bur-eau/Agency/Department;


· based on the risk assessment results of existing chemical substances listed in the List of Priority Chemical Substances drafts risk reducing strategy of such chemical substances and ensures emergency plans are in place;

· ensures compliance with rules on confidentiality of information· prepares regular reports to the EU Commission on implementation of the

EU Directives in the field of chemicals management in Turkey;· in the case that a chemical substance is classified and labelled by the en-

trepreneur as dangerous decides -in cooperation with the MoH and MLSS- about the need to obtain further additional tests based on that it can arise a necessity:

· to incorporate the chemical substance to the List of Priority Chemical Substances; or

· to restrict use or to prohibit placing on the market of this chemical sub-stance;

Ministry of Health: will have the following tasks:· Provides the risk assessment of chemical substances and preparations

from the view of their effects on human health;· Based on the risk assessment results of the existing chemical substances

listed in the List of Priority Chemical Substances drafts risk limiting strategies of such chemical substances and preparations, and provides in-formation to the Ministry of Environment and Forestry on it;

· Keeps informed the Ministry of Environment and Forestry in the case that a chemical substance or preparation is classified and labelled by the company as dangerous, about the need to obtain further additional tests on which results can arise a necessity:

· to incorporate the chemical substance to the List of Priority Chemical Substances; or

· to restrict use or to prohibit placing on the market of this chemical sub-stance;

· Provides its opinion on the import of certain dangerous chemical sub-stances and certain dangerous chemical preparations;

· Registers biocidals· Undertakes inspection and enforcement related to biocidal products.· Ensure the public is informed

Ministry of Labour and Social Security: will have the following tasks:· Provides the risk assessment of chemical substances and preparations

from the view of their effects in view of occupational health and safety;· Drafts risks limiting strategies for workplaces and labour health;· Keeps informed the Ministry of Environment and Forestry in the case

that a chemical substance or preparation is classified and labelled by the company as dangerous, about the need to obtain further additional tests on which results can arise a necessity:

- to incorporate the chemical substance to the List of Priority Chemical Substances; or

- to restrict use or to prohibit placing on the market of this chemical sub-stance;

· Provides its opinion on import of certain substances and preparations;· Undertakes inspection and enforcement in workplaces· Ensure health and safety information is available to workers.

Ministry of Agriculture and Rural Development: will have similar tasks as the Ministry of Health but restricted to pesticides as mentioned in the EU Directives. The MARA will exchange information on its experiences with these substances


with the MoEF and MoH. The Ministry of Agriculture and Rural Affairs will have the following tasks: · Responsible for Pesticides under separate EU Directive and legislation;· Publicise requirements to relevant manufacturers, importers, exporters, etc· Registers pesticides;· Ensure the farmers is informed· Applies Classification & Labelling according to EU Directive 99/45;· No direct tasks related to other chemicals.· Undertakes inspection and enforcement related to Pesticides.

5.2.1.6 Main difficulties and advantages of implementing the differ-ent options

In order to guide selection of the most suitable option for Turkey in setting up the institutional framework, a preliminary SWOT (strengths, weaknesses, threats and opportunities) analysis has been carried out as part of the current strategy, based on a number of criteria which are summarised in Box 3 below.

Box 3: SWOT criteria

Fit with the chemicals management objectives· EU Requirements· Turkish institutional structure

Flexibility to accommodate future change· Flexibility to cope with the changes in EU legislation· Adaptation to REACH system

Implementation Issues:· Institutional acceptability· Cooperation/coordination/collaboration with other institutions· Time requirements· Institutional capacity (people, financial, technical)

Practicality· Number of new institutional bodies established· Number of personnel needed/affected· Personnel regime

These criteria have been applied to all four options and the outcomes are presen-ted below:


Table 3: Option I

Strengths WeaknessesFit with Objectives· Able to cover all the objectives

Accommodation of Future Change· Possible to adjust the structures in a

straightforward manner

Implementation Issues· Relatively easy to implement via exist-

ing legal/institutional structure· Almost no additional time requirement

other than the establishment of NEA· Requires only some additional staff

and training

Practicality· Quite straightforward since legal basis

already exists

Fit with Objectives· Institutional capacity needs to develop to

achieve all the objectivesAccommodation of Future Change· It is not among the preferred options at EU

level

Implementation Issues· Somewhat continuation of the existing institu-

tional structure may lead to sustaining the same problems/issues

· May lead overlaps in the functions within the same administration

· Technical and technological capacity of the Department needs to develop

· Background of the existing staff may not be suitable to undertake new functions

· Demotivation may develop among the existing staff due to restructuring

Practicality· Needs restructuring and assignment of new

tasks within the same department· Personnel policy may not allow for employ-

ment of new highly qualified staff in addition to the existing ones

Opportunities ThreatsFit with Objectives· Potential to develop a fully compliant

system

Accommodation of Future Change· Easy to adapt the institutional structure

if Turkey does not become a member of EU

Implementation Issues· Better communication between the di-

visions for accommodating the imple-mentation of legal amendments in line with the changes in EU legislation

Practicality· EU may require a new personnel re-

gime to be introduced for better imple-mentation

Fit with Objectives· Lack of financial resources or fluctuations of

state turnover may obstruct the institutional de-velopment

Accommodation of Future Change· Might not be acceptable by EU

Implementation Issues· If other institutions decline to collaborate/co-

operate some tasks cannot be accomplished

Practicality· Ministry of Finance may not allow for introdu-

cing a different personnel regime within the same department


Table 4: Option II

Strengths WeaknessesFit with Objectives· Able to cover all the objectives

Accommodation of Future Change· Relatively flexible to accommodate to

the new REACH systemImplementation Issues· New institution may bring new system

with new motivation· Newly employed staff may be more

motivated· May open new capacity building op-

portunities

Practicality· Strengthens the MoEF in general by

adding a new institution


achieve all the objectivesAccommodation of Future Change· Necessity to start from zero in developing this

structureImplementation Issues· Require establishment of a revolving fund· Requires time to establish the Agency in addi-

tion to the time required for the establishment of NEA

· Might be perceived by other institutions as too inexperienced to coordinate/cooperate

· Possible overlaps with the duties of NEAPracticality· Requires issuing a new organic law for the es-

tablishment of the agency· Requires amendments in the Organic Law of

the MoEF· Might be relatively costly to establish a new

agency in addition to NEA· Requires employment of new administrative

support staff in addition to the ones in the Chemicals Management Department and NEA

Opportunities ThreatsFit with Objectives· Might be very well accepted by EU

Accommodation of Future Change· Easy to adapt to the REACH system

Implementation Issues· Opportunity to review existing imple-

mentation structures and amend imple-mentation mechanisms

Practicality· Creates new posts for employment· Opportunity to employ highly qualified

staff with a new personnel regime· May lead to new capacity building op-

portunities

Fit with Objectives· Potential for duplication or conflicts with the

Chemicals Management Department if Turkey does not become a member of EU

· May fall too low in ranking in the organisa-tional structure of Turkish State to undertake an effective role

Accommodation of Future Change· May become obsolete if Turkey does not be-

come a member of EU

Implementation Issues· Low acceptability of a new agency in addition

to NEA in Turkish administrative system· There might be some overlaps with the Chemic-

als Management Department in policy making and relations with EU

Practicality· Risk of not getting approval from the Ministry

of Finance for a new personnel regime


Table 5: Option III

Strengths WeaknessesFit with Objectives· Able to cover all the objectives · More clearly defined roles compared to

Option 2 and 4.· More integrated functions within one in-

stitution compared to Options 1, 2 and 4.

Accommodation of Future Change· Relatively more flexible to accommod-

ate all future changesImplementation Issues· Newly establishing NEA can easily ac-

commodate Chemicals Department · Newly establishing NEA may bring new

system with new motivation· Newly employed staff may be more mo-

tivated· Better coordination between the tech-

nical departments and inspectionPracticality· No additional Organic Law to be issued

other than NEA’s.


achieve all the objectives

Accommodation of Future Change· NEA is not yet established and the parlia-

mentary procedure is very time consumingImplementation Issues· Will require establishment of a revolving

fund· Might be perceived by other institutions as

too inexperienced to coordinate/collaborate/ cooperate

Practicality· Requires issuing a new organic law for the

establishment of the NEA· Requires amendments in the Organic Law

of the MoEFOpportunities ThreatsFit with Objectives· Risks to accommodate a new agency in

Turkish institutional structure

Accommodation of Future Change· Easy to adapt to the REACH system· May easily get support from EUImplementation Issues· Opportunity to review existing imple-


Practicality· Opportunity to employ highly qualified

staff with a new personnel policy and waging system within NEA

· May lead to new capacity building op-portunities

Fit with Objectives· May fall too low in ranking in the organisa-

tional structure of Turkish State to under-take an effective role

Accommodation of Future Change· Delay in establishing NEA and subsequently

modifying its rolesImplementation Issues· There might be some overlaps with the

Chemicals Management Department in policy making and relations with EU

Practicality· No additional risk of not getting approval

from the Ministry of Finance for a new per-sonnel regime other than for NEA.


Table 6: Option IV

Strengths WeaknessesFit with Objectives· Able to cover all the objectives includ-

ing the objectives for the management of biocidals

· Can easily carry out registration as well as both environmental and health risk assessment functions

Accommodation of Future Change· May well accommodate REACH

Implementation Issues· New institution may bring new system

with new motivation· Newly employed staff may be more

motivated· May open new capacity building op-

portunities· Relatively less costly compared to Op-

tion 2, where there two separate agen-cies: one for chemicals and one for biocidals

Practicality· The new institution established can

contribute to avoidance of overlaps between the regimes for biocides and chemicals

Fit with Objectives· Difficult to fit into the Turkish administrative

system, since one agency cannot be affiliated to two ministries

Accommodation of Future Change· Necessity to create a structure under the sub-

ordination of two ministriesImplementation Issues· Will require establishment of a revolving

fund· Requires time to establish the Agency in ad-

dition to the time required for the establish-ment of NEA

· Might be perceived by other institutions as too inexperienced to coordinate/cooperate

· Possible overlaps with the duties of NEA· Not clearly defined working relations to carry

out inspection· Accountable and reporting to which institu-

tion might be a problem areaPracticality· Requires issuing a new organic law for the

establishment of the agency· Requires amendments in the Organic Laws of

the MoEF and MoH· Might be relatively costly to establish a new

agency Opportunities ThreatsFit with Objectives· Might be well accepted by EU

Accommodation of Future Change· Relative more flexible to adapt to the

REACH systemImplementation Issues· Opportunity to review existing imple-


Practicality· Opportunity to employ highly qualified

staff with a new personnel policy and waging system

· May lead to new capacity building op-portunities

Fit with Objectives· Potential for duplication or conflicts with the

MoEF and MoH if Turkey does not become a member of EU

· May fall too low in ranking in the organisa-tional structure of Turkish State to undertake an effective role

Accommodation of Future Change· May become obsolete if Turkey does not be-

come a member of EUImplementation Issues· Low acceptability of a new agency in addi-

tion to NEA in Turkish administrative system· There might be some overlaps in policy mak-

ing and EU relations functions of the MoEF and MoH.

Practicality· Risk of not getting approval from the Min-

istry of Finance for a new personnel regime


5.2.2 Setting up of procedures and work methodology of the com-petent authority/es

In order to ensure the implementation of planning requirements of the chemicals legislation the main attention will be focused on improvement and extension of co-operation of existing and new established competent authorities. This will be achieved by the development and introduction of programme of communication and collaboration among offices of the government and other stakeholders to define and apply transparent policy of co-operation with competency clearly ad-dressed. Programmes for training and education of staff to provide them with the skills necessary will be developed and implemented. Additionally, effective work procedure between the competent authority and the other relevant authorities with responsibilities within chemical sector will be established, especially in terms of protocols for handling of notifications and the results of evaluation procedures, as well as information exchange.

The implementation process will also be supported by the development of relev-ant guidance documents address to:· manufacturers, importers and distributors on the notification procedure

(providing standards forms to assist notifiers in submitting data and the competent authorities in judging whether sufficient data has been submit-ted), as well as the requirements relating to classification, packaging and labelling of dangerous substances and preparations, in one hand;

· competent authority/es on carrying out risk assessment based on its four steps (hazard identification, dose-response assessment, exposure assess-ment and characterization of the risk to human heath and environment), in the other hand.

The current EU funded project “Technical Assistance in the field of chemicals” is supporting the ministry in preparing a guide for manufacturers, importers and dis-tributors on the notification procedure, as well as a manual for the use of compet-ent authority/es’ representatives in handling the notifications and to carry out the evaluation of the technical dossiers submitted by the industry. Nevertheless, addi-tional guidance documents are needed, such as manuals for industry on classifica-tion packaging and labelling of dangerous substances and preparations.

It must be noted that the full implementation of the risk assessment requirements for “new substances” implies the implementation of Good Laboratories Practices, as well as the EN 45000 accreditation system for the laboratories. Considering that the current strategy is focused on the four EU Directives mentioned in its in-troductory part, the implementation actions including the relevant cost associated to the proper implementation of GLP legislation are not taken into account in the current draft.

5.2.3 Information collection on chemicals, data processing and management

The proper implementation of the chemicals legislation requires to have an over-view of the chemicals are being used or processed in Turkey, as well as in the view of accession process, to identify the chemicals that are not yet present in the EU databases. For these purposes the following implementation actions are fore-seen:· Design the registration and data collection system, as well as the data

processing and management;


· Preparing the national inventory on chemicals, link to the EINECS data-base organized at EU level for existing substances and the ELINCS data-base storing the new chemicals at EU level, taking also into account the High Production Volume Chemicals (the chemicals with production or import volume in excess of 1,000 tone/year) and Lower Volume Chemic-als (the chemicals with production or import exceeding 10 tones/year but not greater than 1,000 tones/year);

· Preparing the national priority list, based on the effects of the substances to human health and the environment, the exposure of human or the en-vironment to substances and the lack of data on the effects of the sub-stances on human and environment.

A registration system, including data management and processing, as well as an initial inventory will be prepared by the technical assistance project in field of chemicals. In order to ensure the efficient used of the registration system a manual for database’ users will be also prepared as part of the project. Neverthe-less, taking into account that the establishment of a chemicals information sys-tem, as well as a harmonized system for chemicals and environmental statistics has to be achieved, the IUCLID database has to be prepared.

5.2.4 Supervision, control and enforcement actionsEnforcement is a vital part of the implementation plan. The enforcement agencies for each directive have been identified and the staff will receive appropriate train-ing. The sanctions currently applied in the case of non-compliance with standards will be reviewed and, if necessary, revised.

In order to support the inspection activities, manuals for inspectors, including rel-evant checklists for the use of inspectors have to be developed. The inspector’s manual prepared under the EU funded project “Technical Assistance in the field of chemicals” will be subject of revision / up-dating, based on the government’s decision related to designation of the competent authority.

Taking into account the existing institutional framework and the key requirements for inspection and enforcement that have to be introduced by the chemical legisla-tion, the relevant tasks should be integrated in the current inspection practices. In designing the inspection system, it is assumed that the inspection will be carried out at provincial level, the inspection unit within MoEF playing a coordinating role and in the specific case of chemicals, acting also as a “help desk” for the rep-resentatives of Provincial Directorates of Environment and Forestry.

5.2.5 Training of the staff involved in the implementation processTraining and educational programs for experts capable to carry out documentation control for notification of new chemicals, risk assessment, knowledge and in-formation utilisation provided by EU and OECD etc. is an essential activity as part of the implementation plan. The following key actions are considered, in or-der to provide the staff with necessary skills:· Design and implement a “train of trainer” programme, preparing future

trainers in the field of chemicals capable to ensure the implementation of further training sessions on implementation and enforcement of chemic-als legislation;

· Design a training mechanism and training programme for the representat-ives of the competent authority/es and other stakeholders, taking into ac-count the expertise acquired by the “core of trainers” mentioned above;

· Provide permanent training to the staff involve in the implementation process, as well as to the “new comers” who will be hired by the compet-


ent authority/es as part of institutional strengthening programme pro-posed (see the section below);

· Design a special training programme for inspectors at central and provin-cial level.

The EU funded project “Technical assistance in the field of chemicals” is deliver-ing training sessions for the representatives of MoEF and other relevant govern-mental bodies, supplemented by study tours, preparing a “core of future trainers” in the field of chemicals able to further provide training sessions. It is the Turkish approach to use the trainers prepared under this project to deliver training ses-sions to other representatives of the competent authority/es and relevant stake-holders.

5.2.6 Information and communication programmeA wider information and communication programme has to be design, in order to ensure that the relevant target groups (manufactures, importers and distributors) are aware of their roles and responsibilities under the new chemicals legislation, transposing EU Directives.

5.2.7 Reporting requirementsThe reporting obligations will be effective from the date of accession, but the Government intends to communicate its plans and legal provisions etc. prior to accession. Adjustments in data collection and processing systems will be made in order to be able to provide the Commission with data in the required formats on a voluntary basis prior to Turkey Republic becoming a member state.

5.2.8 Overview of the implementation actionsThe list on the following pages contains the milestones for the most important and urgent implementation activities. Even if, the bulk of the activities must be completed before the date of accession, it is the commitment of the Turkish Gov-ernment to note important progresses in the implementation process, prior to Turkish republic becoming a member state.

December 2007Action Responsible

The secondary legislation ensuring full transposition of EU chemicals legislation in force

MoEF

The implementation procedures in place, including the relevant guidelines developed

MoEF

Registration system and data collection system designed MoEFJune 2008

Competent authority established, organisation chart in place and restructuring process completed and fully op-erating

MoEF, MoH, MoLSS

Monitoring and inspection procedures in place MoEF, MoH, MoLSS

Work procedure between the competent authority and other relevant stakeholders on information exchange in place

MoEF, MoH, MoLSS, MARD

December 2008


Guidance documents revised/up-date, taking into ac-count the anticipated further developments within the sector

MoEF

Training programme for the period 2009-2014 de-veloped

MoEF, MoH, MoLSS

National inventory on chemicals, EINECS and ELINCS databases prepared

MoEF, MoH, MoLSS

Communication and information programmes de-veloped

MoEF, MoH, MoLSS

December 2009Target group informed and trained MoEF, MoH,

MoLSSFull application of all requirements to all economic op-erators

MoEF, MoH, MoLSS

December 2010Full operation of competent authority: staff hired and trained

MoEF, MoH, MoLSS

Staff trained on the implementation of the relevant le-gislation, including inspection and control - continu-ously

MoEF, MoH, MoLSS

Chemicals - EC Information and reporting systems de-veloped

MoEF, MoH, MoLSS

5.2.9 Further action needed to complete institutional strengtheningThe implementation of the chemicals legislation’s provisions is especially based on the existing institutional capacity, but the latter needs an increase of the num-ber of personnel involved in the implementation process, especially on inspection and enforcement. These are presented in Table 7 below:

Table 7: Institutions involved in chemicals management and require-ments

Goal Institutions in-volved

Requirements

Notification proced-ure: checking the technical dossier

MoEF, MoH, MoLSS

Increase of the personnel’s number and of its training degreeTraining courses’ organizationParticipation in international semin-aries, training courses, etc.

Risk assessment MoEF, MoH (RS Hygienic institute), MoLSS

Provides the risk assessment of chemical substances and preparations from the view of their effects on hu-man health and environment;Propose and draft risk reduction strategies

Control and enfor-cing of the compli-ance with the chemic-als legislation

MoEF, MoH, MoLSS

Increase of the personnel’s number and of its training degreeTraining courses’ organizationParticipation in international semin-aries, training courses, etc


For the proper implementation of the chemicals legislation, the need for addi-tional staff within the public institutions is foreseen.

A significant increase in the personnel number is required for implementing the notification requirements for “new substances”, carrying out risk assessment and designing risk reduction strategies, if applicable, as well as for inspection and control, which are currently carried out with limited personnel resources, as fol-lows:· 7 additional staff at central level within MoEF: 2 chemists with toxico-

logy background, 1 IT expert and 2 chemical engineers, as well as 2 in-spectors with chemical background;

· 40 additional staff at provincial level within PDEF, responsible for in-spection and enforcement: mainly chemists and chemical engineers. The additional personnel will be distributed to those PDEF governing the provinces were the chemical industry is concentrated;

· 2 additional personnel with a strong toxicology expertise working within RS Hygienic Institute to support the implementation of risk assessment for human health legislation.

It is assumed that the necessary administrative bodies will be staffed gradually, starting when the legislation is in place, and that they will be fully staffed by 2010. The table below shows the number of staff, measured in terms of full time employees, estimated to be needed to meet the approximation requirements for public administration of the chemicals legislation.

Estimated additional staff needs for the implementation of chemicals legislation at central and provincial (full time employees):

Table 8: Estimated additional staff needs

Implementation actions Year2007 2008 2009 2010

Notification procedure 1 1 1Risk assessment 4Inspection, control and enforcement 2 10 20 10Total 3 15 21 10

The strengthening of the institutional capacity for ensuring the implementation of the chemicals legislation will be achieved through:· the current EU funded project “Technical Assistance in the field of chem-

icals” for strengthening the institutional capacity of the Ministry of Envir-onment and Forestry and other relevant governmental bodies;

· staff redistribution and employment/supplementation by the ongoing re-organisation process of the environmental authorities (see the assumption related to the establishment of National Environmental Agency) in order to ensure a more efficient activity and to increase the number of chem-istry specialists working within the Chemical Department within MoEF.


6 Cost assessment and financial plan

6.1 Cost assessmentThe approximation costs associated with directives that regulate the chemicals sector activities will be almost exclusively public administration costs. The reason for this is based on the following two observations. First, as noted above, chemical and allied product firms operating in Turkey do not, at this time develop new or innovative chemicals or products. There is no expectation that this will change. These firms will, therefore, be spared any direct cost of testing the prop-erties and safety of new chemicals under the directives. Second, sector experts have found that most of the other requirements of the directives affecting firms engaged in production and marketing of chemicals and related products have already been undertaken by the firms operating in Turkey.

As a consequence, the main costs related to the implementa-tion of the chemicals legislation are the administrative costs associated with the institutional strengthening process and the cost for ensuring that the laboratories used to support the implementation of the risk assessment legislation comply with the Good Laboratories Practices requirements, including their accreditation system. Taking into account the scope of the current strategy (focused on the four EU Directives mentioned in its introductory part), only the costs related to institutional strengthening process are assessed, covering:· Operational costs: costs with the personnel who has to be part of the re-

sponsible institutional structures, respectively:- Ministry of Environment and Forestry as the competent national authority

and its subordinated bodies;- Other relevant governmental bodies (Ministry of Health, Ministry of La-

bour and Social Security, etc.).· Investment costs: administrative costs required by the activities of the in-

stitutional structures involved in the implementation of the chemicals le-gislation (purchase of IT equipment, IUCLID software, etc.);

· Investment costs: costs related to communication and information, in-cluding the publication and dissemination of guidance materials, as well as the cost associated with training activities envisage for ensuring the ef-ficient implementation of the legislation.

6.1.1 IntroductionIn cost studies a distinction is usually made between investment and operating costs (see the terminology box below). The Government of Turkey will only need to invest in equipment related to record keeping, confidentiality, monitoring, and enforcement. Some investment in human resources, in the form of staff training, is anticipated as mentioned in the implementation plan and as it mentioned above communication, information and guidance preparation and disseminations is also


included as investment cost. The training costs are estimated to be roughly estim-ated at 6,000 EURO per employee trained, assuming that each trainees will re-ceive at least two types of training: on general understanding of chemicals legisla-tion and on specific topics: risk assessment, classification, packaging and la-belling, inspection and enforcement actions, etc. It is also assumed that training sessions will receive not only the “new comers”, but also the existing staff work-ing within inspection department at central and provincial level. Further training will be also provided to the existing staff working within Chemical Department, after the chemicals legislation enter into force.

Box 4: Selected assumptions used for cost calculations

Monetary units are year 2006 Turkish lira (TL) and year 2006 EURO.

Approximation costs are calculated over and above a baseline condition during the period of analysis. The baseline is typically anchored on the existing structure of technology and level of activity in public and private enterprises.

Wherever possible market prices are used as the economic cost of goods and services. This should provide sufficiently accurate estimates of cost so long as prices do not change significantly as a result of addi-tional costs.

Conversion rate: 1.85 TL = 1.00 EURO.

Operating costs are estimated using estimates of staffing requirements and in-formation on the current cost of supporting a full time staff member working in public administration. The full cost for an employee considered is roughly aver-ages 9,600 EURO per year.

6.1.2 Cost summaryIn meeting the objectives of the chemicals legislation, especially with regard of avoiding harm to the environment or to human health through environmental ex-posure to chemicals, the following cost have been assessed:· Investment cost as were defined above: 1,546,000 EURO, including

- 714,000 EURO training cost for 119 persons (49 “new comers”, 5 from ex-isting Inspection Department within MoEF, 10 from existing Chemical De-partment and 45 working at provincial level, as well as 10 representatives of other relevant governmental bodies);

- 112,000 EURO other investment administrative costs (IT equipment, IUC-LID database purchase, etc.) and

- 720,000 EURO the cost related to the implementation of wider communic-ation and information programme for manufactures, importers and distrib-utors;

· Operational cost: 882,000 EURO representing the salaries of the addi-tional personnel envisage in order to ensure the proper implementation of the chemicals legislation (49 employees).

6.1.3 Financial plan and financial resources

Total investment expenditures from the State budget and external finan-cial assistance (e.g. implementing training activities, designing and imple-menting a wider communication and information programme) in the period 2007-2010 are presented in the Table below:


Table 9: Summary and distribution of expenses for the implementation of chemicals legislation

Costs Year Total cu-mulated value2007 2008 2009 2010

Investment cost

Training cost 180,000 180,000 180,000 174,000 714,000

Administrative costs

20,000 30,000 42,000 20,000 112,000

Communication and information

programme

70,000 100,000 550,000 720,00

Operational cost

54,000 270,000 378,000 180,000 882,000

2,428,000

The implementation of the chemicals legislation is supported by the on going EU funded project “Technical Assistance for strengthening the institutional structure and capacity in the field of chemicals” ending in May 2007, which will ensure:· Full transposition of the 4 EU Directives subject of the current approxim-

ation strategy;· Guidance materials for the use of competent authority/es and manufac-

tures, importers and distributors;· Training and “train of trainers” session, including study tours: 15 repres-

entatives of MoEF and other relevant governmental bodies will be train to act as future trainers on the key requirements of the chemicals legisla-tion;

· National chemicals inventory, database and registration system.

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