CHEMICALS MANAGEMENT IN THE REPUBLIC OF · PDF fileOmladinskih brigada 1 11 000 Belgrade. ......

CHEMICALS MANAGEMENT IN THE REPUBLIC OF SERBIAElements of Legislation on

Chemicals Management

Sonja Roglic,SAICM Focal Point

REPUBLIC OF SERBIA,Ministry of Agriculture and Environmental Protection

SAICM ICCM 4, 28 September – 2 October 2015, Geneva - Switzerland

Chemicals Risk Management in Serbia

By preparation of the new legislative framework in the Republic of Serbia,the basis for the new chemicals risk management was prepared. This wasessential because it completely changed the way in which the chemicals aremanaged.

Cooperation with Swedish Chemicals Agency (KemI) began in 2005.

Specific Agreement between Sweden (represented by Swedish International

Development Cooperation Agency-SIDA) and Serbia was signed in 2008.

Project office was established in November 2008

Memorandum of Cooperation between the CA of the Republic of Serbia and KemI

was signed in 2008.

I phase of the project finshed in 2010

Project „Chemicals Risk Management in Serbia – phase 2“ from 2010 to 2015.


Legal arrangements supporting the chemicals management in Serbia

1. COMPETENT AUTHORITY (CA)

Ministry of Agriculture and Environmental

Protection is the competent authority for chemicals

management, with the Department for Chemicals as

the central administration.

2. LEGISLATIVE FRAMEWORK

National legislation has been harmonised with

EU Acquis within the appropriate scope and legislative

framework to the maximum extent possible for a non-

member countrySAICM ICCM 4, 28 September – 2 October

2015, Geneva - Switzerland

COMPETENT AUTHORITY (CA)


ADMINISTRATIVE CAPACITIES

•Central staffs have acquired knowledge and practicalexperience on implementation of provisions of the Law, duringseveral years;•Participation as an observer in CARACAL, Help Net and Forummeetings;•Capacities of central staffs and inspectors have been built withsupport of international projects:

“Chemicals Risk Management in Serbia” - KemI/SIDA

IPA 2008 “Strengthening Administrative Capacities for the Implementationof a Chemicals Management System”“Preparatory measures for the participation of candidate countries andpotential candidates in and their cooperation with the European ChemicalsAgency ” -ECHA’s IPA projectIPA 2013 “Further development of chemicals and biocidal productsmanagement in RS “- started in September 2015


Enforcement

•Supervision over implementation of the Law on Chemicals andregulation promulgated thereof shall be done by the Ministrycompetent for environmental protection.•Two additional ministries are responsible for inspection andcontrol of chemicals placed on the market, the Ministrycompetent for trade via market inspectors and the Ministrycompetent for health via sanitary inspectors.•Inspections authorities shall cooperate, inform each otherabout the undertaken measures, exchange information andundertake joint activities relevant for enforcement of the law


LEGISLATIVE FRAMEWORK


Law on biocidal products

Law on chemicals29 by-lows

Law on CWC implementation Law on Ratification of Rotterdam

ConventionLaw on Ratification of Stockholm

Convention

Law on Chemicals

Law on chemicals* has been in placesince 2009.•Objectives:

Establishment, maintenance andimprovement of unique system ofChemicals management in Serbia

Assurance of high level of health andenvironment protection

Improvement of trade with chemicals


Law on chemicals regulates:

Integrated Chemicals Registry (includes Registry of chemicals, biocidal

products and PPP placed on the market);

classification, packaging and labelling of chemicals;

bans and restrictions of production, placing on the market and use of

chemicals;

Import and export of certain hazardous chemicals;

permits for placing on the market and use of particularly hazardous

chemicals;

integrated chemicals management;

chemicals advisor;

detergents;

systematic monitoring of chemicals;

data availability;

supervision and other important issues.


Law on chemicals is harmonized with EU legislation:

Regulation 1907/2006 /EC on registration, evaluation and authorization on

chemicals (REACH) – partially harmonised – approximation

Regulation 1272/2008/EC on classification, labelling and packaging of

substances and mixtures in accordance with GHS

Regulation 440/2008/ЕС on test methods pursuant to REACH

Directive 2004/42/EC on limitation of emissions of volatile organic

compounds (VOC) from the use of organic solvents in certain paints, varnishes

and vehicle refinishing products

Regulation 648/2004 /EC on detergents

Regulation 649/2012/EU on export and import of hazardous chemicals

Regulation 850/2004/EC on POPs


Mainstream – to apply all the relevant parts of REACH which can be transposed into

legislation of non-EU country (i.e. centralized procedures can not be transposed)


Approximation to REACH

List of substances of

very high concern

List of banned and restricted

substances (Annex XVII)

Other details on REACH transposition into Law on Chemicals

Information in the supply chain and access toinformation:

Safety data sheet and criteria on PBT& vPvB

National Help Desk was established with aim to providesupport and advice to manufactures, importers, downstreamusers, distributors and other interested parties to adequatelyfulfil their obligations and responsibilities laid down bychemicals legislation.

Republic of Serbia also obtained status of an observerin the European network HelpNET formed of help-desksof 28 EU Member States, including central help-desk ofthe European Chemicals Agency (ECHA)


Systems for classification, labelling and packaging of chemicals

Globally Harmonized System of Classification and Labelling of Chemicals in

accordance with Regulation 1272/2008 (Globally Harmonized System of

Classification and Labelling of Chemicals - GHS)


Chemicals Industry in Republic of Serbia

•Chemicals Industry holds significant share in national economyc.a.1.700 Legal Entities (duty-holders) identified.

•Majority of SMEs and MicroEs;•30 000 – 40 000 chemicals (i.e. substances and mixtures) placed on the market in quantityof c.a. 9.000.000 ton.

3.900.000 ton of chemicals manufactured in Serbia (43%)4.050.000 ton of chemicals imported from EU countries (45%)1.050.000 ton of chemicals imported from non EU countries (12%)

(Ref: Chemicals Registry, 2011).


Law on biocidal products

Law on biocidal products* has been in place since 2009.

Directive 98/8/EC concerning placing of biocidal products on market –

transposed into the Law on Biocidal Products

Aim: to assure that biocidal products placed on Serbian market :

- are efficient enough to destroy or control harmful organisms,

- do not present unacceptable risk for humans, target organisms,

other organisms and/or environment;

Lists of active substances in biocidal product – transposed

Prescribed authorization for placing of BP on Serbian market if it contains

active substance given in these lists

Transitional permit – until authorization deadline

New Law on biocidal products – according to Regulation 528/2012/EU

until the end 2016.SAICM ICCM 4, 28 September – 2 October

2015, Geneva - Switzerland

56%

12%

8%

18%

6%

BPs placed on the Serbian market

Disinfectants

Preservatives

Rodenticides

Insecticides

Repellents

Ref: Register for Biocidal Products (September 2014)

Biocidal products in Republic of Serbia

EXPERINCE IN PRACTICE

•Adequate knowledge on chemicals is available and will becontinuously improved;•Cooperation and permanent dialogue with industry isestablished and maintained (e.g. regarding determination ofdeadlines for entry into application of bans and restriction)•Numerous workshops for industry were organized•Data from Integrated Chemicals Registry are used as support inimplementation (bans and restrictions, SDS, CLP, PIC etc.) and inproviding overview of manufacturers, importers anddownstream users of chemicals.•Annually, Helpdesk answers to over 2400 requests by phoneand around 200 via e-mail•Inspectors have received trainings, took part in workshopswhere case studies were discussed within the internationalcooperation projects;•A few Pilot inspections were performed with participation of


Further changes

•Amendments to the Chemical’s Acquis will be continuouslyimplemented•Further improvement of administrative capacities with highlevel of professional knowledge•Identification and determination of additional competentinstitutions which will fulfil specific requirements prescribed byChemical’s Acquis•Establishment of a national cluster of relevant expertise asexternal support (e.g. to evaluate substances, to prepare/submitdossiers for identification of SVHC and proposals forrestrictions…)•Awareness raising activities related to sound riskmanagement and use of chemicals for stakeholders•Activities related to support of development of NGO sector inchemicals management area


Thank you for your attention

Sonja Roglic, Head of Department for [email protected]


Ministry of Agriculture and Environmental Protection,Omladinskih brigada 111 000 Belgrade

ICCM-4 Brazil Side Eventthe role industry associations in developing

countries play under Responsible Care

and how

developing countries can benefit from learning

about risk based approaches

ICCA Presentation

Gordon Lloyd

Chemistry Industry Association of Canada

Some benefits for developing countries from local

associations and ICCA activities• 75 ICCA workshops in 38 countries re ICCA Global

Product Strategy (GPS)

• over 4,500 safety summaries

• 172 capacity building projects in 46 countries/ regions

• Promoting GHS (labels & safety data sheets)

• Workshops on emergency preparedness and response

• ICCA partnership with UNEP

• Pushed SAICM to focus on developing country needs

• Global companies tend to raise the bar locally

Some ICCA learnings from our developingcountry activities

• Importance of mainstreaming chemicals management in developing country funding

• More needs to be done at the national level to improve public confidence in chemicals management

• Challenges countries face in developing their national

chemicals programs and legislation

– Consider the approach of the South American delegation visit to Canada this June to discuss CMP (Canada’s Chemical Management Plan)

South American delegation visit to Canada• Government & industry delegation from 3 Countries

• Discussed Canada’s CMP with

– Chemistry Industry Association of Canada and

– Health Canada & Environment Canada

• Intensive and thorough 4 day discussions

• Results may provide some ideas about cooperation

with Canada (using CMP results) to reduce costs for:

– Countries wanting to develop their own program

– Countries wanting to use some CMP results

Some CMP approaches to consider: what works 1/4• Science / risk based & transparent program

• Goal of improving public confidence in chemicals management

• Government assessments help public confidence

– Industry provides necessary data

• CMP prioritizes and chooses what needs assessing and this minimizes resources spent

• Assessments based on just enough data for a justifiable decisions. Not “filling data gaps”, but doing work where work is needed

Some CMP approaches to consider: what works 2/4• The ~ 23,000 chemicals in commerce in Canada were

prioritized as to what needed assessment by a screen using persistence, bioaccumulation, toxicity, high hazard and exposure: ~ 4,300

• A major 6 year project required by law: CEPA 99

• The remaining ~19,000 were not seen as warranting assessment unless new information emerges

• The ~ 4,300 assessments are to be done by 2020.

• 3 five year plans: CMP1, CMP2, CMP 3

• Generally consistent industry & NGO support due to engagement & a sound program

Some CMP approaches to consider: what works 3/4• To date assessment process generally seen as challenging

but successful

– Targets generally met for CMP1

– CMP2 generally on track with some minor delays

– CMP3 in the design stage

• Substances assessed as toxic (presenting a risk) are controlled by government – regulated or other measures

• Relatively little risk management has been needed

– Substances are generally being well managed,

– Relatively few toxic findings; most required limited and reasonable measures

Some CMP approaches to consider: what works 4/4• Well-funded, strong and sustained government

commitment

• Maintained a focused, prioritized approach so CMP uses

industry and government resources effectively

– identifying the priority substances for assessment

– assessments collect just enough data and do enough

assessment work for an assessment decision.

– “Screening assessments”, not full risk assessments

• Good documentation provided by government on website

• CMP could be a model to consider by other countries

Countries that want to develop their own program The CMP model:

• Efficient use of resources as prioritized, risk based and “work where work is needed” (better allocates resources).

• Has improved public confidence in chemicals

management and enjoyed industry and NGO support

• Has shown it is a workable approach:

• Canada with CMP is doing far more assessments than

other countries and is starting to become a leader in many

new and evolving risk assessment tools

• No trade distorting registration requirements

Countries with minimal programs can also benefit from CMP

• In deciding what chemicals to focus on nationally,

(although exposure factors may differ), consider:

– CMP has determined ~19,000 chemicals used in Canada do not warrant assessment (unless new information suggests otherwise)

– CMP has risk assessed ~2,700 chemicals and concluded only 97 substances or groups of substances are toxic, and the rest not

– Canada has these lists. They may be helpful to some developing countries in deciding what to not focus on, and what to focus on

Conclusions for developing countries to consider• Actions are taking place, but more needs to be done

at the national level to build public confidence in chemicals management

• Under Responsible Care local associations and ICCA are working to be strong partners in improving chemicals management in developing countries

• In developing national legislation on chemicals

control, consider some of the aspects of Canada’s

CMP to help manage costs

• South American delegation Canada visit was useful & other regions may want to consider something similar

Further Information

ICCA website

• ICCA GPS

• ICCA Safety Summaries (GPS Chemicals Portal)

• ICCA capacity building work

Canada’s CMP

– http://www.chemicalsubstanceschimiques.gc.ca

http://www.icca-chem.org/en/Home/Global-Product-Strategy/global-product-strategy/chemical-information-search/

http://www.chemicalsubstanceschimiques.gc.ca/

Experiences from Chemicals Management Cooperation activities

Maria Delvin Swedish Chemicals Agency, KemI

Annual joint meeting between regional centres

6 October 2015

Cooperation activities

1.International Training Programme

2.Global programme

3.Regional cooperation

4.Bilateral cooperation

1. International Training Programme

”Strategies for Chemicals Management”

ITP – participantsBotswana Bangladesh Albania

Burkina Faso Philippines Armenia

Ghana India Bosnia/Herzegovina

Kenya Indonesia Georgia

Malawi Cambodia Kosovo

Moçambique China Croatia

Namibia Laos Macedonia

Nigeria Mongolia Moldavia

Rwanda Nepal Montenegro

South Africa Pakistan Serbia

Tanzania Sri Lanka Tajikistan

Uganda Thailand Turkey

Zambia Vietnam Ukraine

Zimbabwe Belorussia

Brazil 10

Uruguay 1

Global programme

contribute to providing the basis for countries to raise their

capacity to reduce the risks associated with chemicals,

Regional cooperation

Regional programme in South East Asia

Regional centers – Africa institute

University of Cape Town

Bilateral cooperation with Serbia

Chemicals legislation

Institutional capacity development

Bilateral cooperation

Brazil

Uruguay

Indonesia

China

Vietnam

South Africa

Tunisia (EU-twinning)

Earlier: Tanzania, Macedonia, Croatia, Hungary, Poland,

the Baltic states, Albania

Main experiences

- Useful to have several persons from the same country

attending the ITP

- Useful to share experiences in legislation and in

implementation

Roles and responsibilities has to be defined in legislation

Make use of already existing information on chemicals

Political will is needed

”Det övergripande målet för miljöpolitiken är att till nästa generation lämna över ett samhälle där de stora miljöproblemen är lösta, utan att orsaka ökade miljö-och

hälsoproblem utanför Sveriges gränser.”RIKSDAGSBESLUT OM MILJÖMÅLEN FOTO: ELLIOT ELLIOT/JOHNÉR

Generational goal

The overall goal of Swedish environmental policy is to hand over to the next

generation a society in which the major environmental problems in Sweden

have been solved, without increasing environmental and health problems

outside Sweden’s borders

11

Implementing the Overall Orientation and Guidance for achieving the 2020 goal. Elements of legislation on chemicals

management

Kaj Madsen, Senior Programme OfficerPolicy Team,Chemicals and Waste BranchUNEP

…………………

……………………

1

UNEP guidance

• Development of legislation

• Development of administrative infrastructures

• Measures for recovering costs of national administrations;

• Called LIRA guidance

Principles of the Guidance

• Part of an integrated, lifecycle chemicals management strategy.

• The placement of chemicals on the market;

• Strong inter‐sectoral and multi‐stakeholders collaboration mechanisms;

• A sound planning process

3

Presenter

Presentation Notes

The review of legal and institutional infrastructures should be part of an integrated, lifecycle chemicals management strategy. Legislation governing the placement of chemicals on the market and institutional arrangements for decision‐making, implementation and enforcement should provide the foundational capacity for lifecycle chemicals management; Strong inter‐sectoral and multi‐stakeholders collaboration mechanisms for SMC should be established; The review should follow a sound planning process in order to ensure the development of coherent, comprehensive and realistic action plans, as well as sustainable financing for the proposed developments.

Policy elements

• Political priority• Why is sound management of chemicals

important

• Agreement between government sector agencies on the need for legislation

• Chemicals legislation is spread over specific sectoral legislation

• Inclusion of private sector and civil society

• Procedures for an open of transparant model

4

Issues identified

• The division of responsibility between the government and industry

• Strengthening/ creating the adequate infrastructure for sound chemical management

• Cost recovery mechanisms and allocation of revenues

• Public awareness

5

Division of responsibility between government and industry

• Importers/ distributors:– Conveying information provided by producers/

manufacturers to downstream actors;– Informing downstream actors in case they have

identified new information with regards to chemicals hazards and risks.

•Producers/ manufacturers:– Pre‐marketing testing and classification;– Labeling and developing Safety Data Sheets;– Updating the information base when required.

6

Division of responsibility between government and industry

Public authorities have the responsibility for:

Enforcing legal requirements and take the required measures to ensure compliance;

Ensuring they rely on up‐to‐date information about risks caused by chemical substances;

Participating in international co‐operation;

Monitoring and report on compliance with the legislation.

7

Administrative infrastructures for sound chemical management

Institutional issues in DCs and CEiTs: Many ministries and agencies involved

Inadequate delegation from parliament and government

Split and unclear responsibilities ‐ overlapping tasks

Lacking of coordination & cooperation

Duplication of work

Conflicts between ministries/ agencies (on mandates, responsibilities, resources allocation, etc.)

Lack of enforcement

8

Coordination

Mechanisms at each level of collaboration: Policy level:

Setting up a coordinating (consultative) body OR other coordination mechanism (MoUs, …)

Allocation of responsibilities and establishment of a central agency Management level:

Establishment of a managing institution OR daily networking Scientific/technical expertise and external institutions

Enforcement level: Specialized and authorized inspectorates for supervision The three intervention points: production/ import, retail, use

Mechanisms across levels: Resources sharing:

Information (multi‐users registers, meta‐data, etc.) Expertise (qualified personnel, inspectors) Finance

9

Cost recovery

Several instruments can recover costs of administrative servicesUser Charges and Taxes on InputsEnvironmental Tariffs for Chemicals,

Chemical Products or Goods Containing Chemical Substances Environmental Fees, Charges and Taxes

on Pollution Control Services, Emissions and Products Disposal Charges on Waste Environmental Liability

All have different impacts and are not possible in every situation

10

Public awareness

• Involving stakeholders in the policy making

• Making information public available• Using private sector and civil societies to

distribute information• Awareness raising workshops in local

communities• Cooperate with journalists

11

12

12

12

Chemicals Branch, Division of Technology, Industry and Economics:

International Environment House 111-13, Chemin des AnémonesCH-1219 Châtelaine, GeneveSwitzerlandTel : +41 (0) 22 917 81 92 E-mail : [email protected]/hazardoussubstances.org

mailto:[email protected]�

The Brazilian Path to Establish Legal and

Administrative Infrastructure to the Sound

Chemicals ManagementDF - Brazil

ICCM4, september/october 2015

Letícia Reis de CarvalhoDirector

Departament of Environmental Quality in the industry

Ministry of the Environment

Brazil

The importance of the Brazilian chemical industry

Fonte: ABIQUIM.

Brazilian Chemical Industry Net Sales – 2014 (*) (US$ bn)

Total:US$ 156,7 bn

Sources: Abiquim and associations of specific segments

(*) Estimated.

91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14

1,5 1,3 2,0 2,9 4,6 5,4 5,86,5 6,3 6,67,2 6,3 6,2

8,6 7,9 8,413,3

23,2

15,720,7

26,528,1

32,0 31,2

Deficit

Brazilian Trade Balance Chemical Products – 1991-2014

91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14

2,1 2,3 2,5 2,8 3,4 3,5 3,8 3,6 3,4 4,0 3,5 3,8 4,8 5,9 7,4 8,910,7 11,9 10,4

13,0

15,8 14,814,2 14,5

3,6 3,6 4,5 5,7 8,0 8,9 9,7 10,1 9,8 10,7 10,810,1 11,014,5 15,3

17,4

23,9

35,1

26,1

33,7

43,046,1 45,7

Exports Imports

Deficit booming1991: US$ 1.5 billion2014 = US$ 31.2 billion

Source: Sistema Aliceweb – MDIC/Secex

DESCRIPTION ∆ 2014/2013

∆ a.a. 2014/1991

IMPORTS (0.9%) +11.7%

EXPORTS +2.6% +8.8%

DEFICIT (2.4%) +14.1%

Brazilian chemicals management schemes

ODS’s

Chemical Weapons

Shipping dangerous goods/ hazardous

materials

Wood preservatives

Pharmaceuticals, cosmetics, household

cleaning products

Pesticides

Asbestos

Oil PollutionChlor Production

Transportation of hazardous substances

Classification and Labelling schemes of substances,

mixtures and transportation of hazardous substances

Wastes

ILO Convention nº 170: Chemical Products on workplace

Explosives

Polichlorinated Byphenils

Benzene

Fertilizers (contaminants)

Mercury

Remediators

Chemical dispersants

Levels of lead in paints

The gap

Comprehensive legislation on Industrial Chemicals:

Absence of a inventory of industrial chemicals placed in the

market and measures to assess and manage their risks.

The proposal to fill the gap

Law Proposal to stablish:

• A national inventory of chemicals – Information System;

• GHS as the System of Classification and Labelling;

• Use of available and reliable national and international database and

substance information sources to reduce costs;

• Industry to provide data, to contribute in assessing hazards and, when

necessary, risks to health and environment;

• Substance prioritization based on risk;

• Risk management measures.

Multi stakeholder working group under National Comission on Chemical Safety:

Government (Environment, Health, Labour, Industry and Trade) – Civil society

(Environment and Employees).

Challenges to elaborate/approve

Challenges to implementation

To obtain hazard information on chemicals

Validate information on international data banks (lack of human resources)

Environmental monitoring (lack of infrastructure)

Qualified professionals: toxicologists, ecotoxicologists, risk management

specialists

Diversity in industries – uneven level of regulatory knowledge

Multinationals X Small and Medium Enterprises

Understanding, support, enforcement, evaluation

Strenghts

ISO Technical Standard on GHS- NBR 14.725)

Voluntary, but used by industries and adopted by MTE

Responsible Care and Global Product Strategy

Industry Voluntary Initiatives

National Commission on Chemical Safety (CONASQ)

Working group on Chemical Safety Education (“mainstreaming”

chemical safety in all education levels)

Strenghts – Best approach (International Cooperation)

UNEP

Seminars on Conventions (SC and Minamata)

Seminar on LIRA Guidance

Guidance and short-term activities: seminars, workshops

European Union (Sectorial Dialogues Project)

Hazardous substances emergency response

Industrial chemicals - Chemicals Management Schemes (EU,

Canada and China)

Pesticides and biocides control Schemes (EU)

Chemicals in products Schemes and Sustainable Government

Purchases

Short-term projects (~ 1 year)

Less bureaucracy (no mid-term reports, just a final)

Faster results (reports, guidelines/handbooks, technical visits,

improved networking, seminars/workshops)


Sweden

International Training Programme

Workshops: GHS (2013), Mercury (2014), Chemical in

Products/Lead in Paints (end of 2015) and Pesticides Risk

Assessment (2016)

Long-term cooperation: Policy and Regulation formulation


Canada

Technical visit to Environment and Health Ministries to get

acquainted with Canadian Chemicals Management Plan –

CMP.

CMP – Risk based approach, lower implementation costs,

supported and recognized both by civil society organizations

and industry, stakeholders integrated system, all risks

assessed.

Possibility of long-term cooperation on chemicals management

approach


To improve coordination and programmatic vision to the 2020 goal

History:

• Brazilian National Commission on Chemical Safety (CONASQ) - first

stablished in 2000 to organize the III IFCS Forum (Bahia);

• National Program on Chemical Safety – 10 lines of action;

• CONASQ: 45 meetings, focusing on specific themes, not programmatic.

The proposal:

A Bill to stablish a National Policy on Chemicals Management:• Focused on the SAICM 2020 Goal;

• Bring coherence and improve coordination among stakeholders;

• Welcoming the policies, programs and activities from different sectors;

• Programmatic vision – 3 years action plan (cooperation, accountability,

indicators).

Conclusion

• Brazil is on its way to adopt a Chemicals Management

Regulation and strenghten our chemicals management

framework at all.

• Gaps Identified: lack of adequate infrastructure, adequate

human resources.

• Need to improve government infrastructure, specialized

human resources, outreach measures, training programs,

build industry technical capacity on GHS, stakeholders

commitment.

Thank You!

Obrigada!

[email protected]

[email protected]

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