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EU WHITE PAPER

Strategy for a Future Chemicals Policy

Michael J. Hynes

National University of Ireland, Galway

Galway Irish Crystal

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White Paper - History

• 13th February 2001

–European Commission adopted a White Paper setting out a strategy for a future Community Policy on Chemicals

• Overriding goal was of “sustainable development” while

–Ensuring a high level of protection of human health and the environment

– Ensuring efficient functioning of the internal market

–Stimulating innovation and competitiveness in the chemical industry

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Guiding Principles

• Scheme’s policies are guided by:

–Precaution and prevention.

–The need to encourage the substitution of dangerous by less dangerous substances, whenever possible.

–Greater responsibility for industry to generate and deliver information and an assessment of risks.

–Openness and transparency of information - the right to know.

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Commisioner Margot Wallström

“We have decided on a step-by-step approach to phase out and substitute the most dangerous substances – the ones that cause cancer, accumulate in our bodies and in our environment and affect our ability to reproduce. This decision is crucial for future generations”

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Background – Weakness of Current System

• Most important are:

–Resources concentrated on ‘new substances’ that make up less than 1% of total volume on the market.

–100,106 ‘existing substances’ may be used without testing.

–Has the effect of stifling innovation in new chemical products – ideally less hazardous ones.

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Weaknesses – (contd)

• Lack of knowledge about dangers of many chemicals on the EU market.

–Makes it difficult to assess their risks and make informed decisions about controlling them.

• Current process of risk assessment is too slow

–Only a handful of chemical substances are assessed at EU level each year

–We now have a first draft of Risk Assessment Report on 85 out of a total of 140 priority substances since 1993

• Burden of proof is on public authorities

• Difficulties with ‘problematic substances’

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Some Statistics?

• 1930 - Global production of chemicals 1 million tonnes

• Today - Global production is 400 million tonnes

• 100,000 different substances registered in EU

• 10,000 marketed at quantities > 10 tonnes

• Further 20,000 marketed at 1 - 10 tonnes

• 1998- Global production of chemicals was €1,244 billion

• 31% in EU with trade surplus of €41 billion

• 1998 EU was largest chemical industry followed by US with 28% of production and surplus of €12 billion

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The EU Chemical Industry

• EU chemical industry vital to EU economy

– one of the last European sectors that is a global leader

• Chemical industry is third largest industry in EU

• Employs 1.7 million with a further 3 million jobs dependent on it

• As well as multinationals we have 36,000 SMEs involved

• SMEs represent 96% of total number of enterprises

• SMEs account for 28% of chemical production

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Existing and New Substances

• Present system distinguishes between “existing substances” and “new substances”.

• Existing substances - chemicals declared to be on the market before September 1981.

• New substances - those placed on the market after September 1981.

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The Problems (2)

• New substances

–number about 2,700

• Testing and assessing risks to human health and environment under Directive 67/548 before marketing in quantities > 10 kg

• Existing substances

–100,106 declared

–30,000 marketed at > 1 tonne at present

–Not subjected to same testing/risk assessment

–Account for 99% of total volume of all substances on the market at present

–140 identified as priority substances

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Political Objectives of Proposed Strategy

• Protection of human health and the environment

• Maintenance and enhancement of the competitiveness of the EU chemical industry

• Prevent fragmentation of internal market

• Increased transparency - customers

• Integration with international efforts - global nature of chemicals industry, trans-boundary impact

• Promotion of non-animal testing

• Conformity with EU international obligations under the WTO - do not create trade barriers

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The New System for Chemicals Control-The REACH System

• Registration, Evaluation and Authorisation of Chemicals

• Aim

–to establish a single coherent system focussing public resources on those substances, where, according to experience, the involvement of authorities is indispensable and the added value in terms of the provision of safety is substantial.

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Registration

• Registration of the basic information for around

30,000 substances submitted by companies

contained in a central database.

• This includes all existing and new substances

exceeding a production volume of 1 tonne.

• It is estimated that around 80% of these

substances would only require registration.

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Deadlines for Registration

• 1,000 tonnes – at the latest by end of 2005

• 100 tonnes – at the latest by end of 2008

• 1 tonne – at the latest by end of 2012

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Evaluation

• Evaluation of the registered information for all substances exceeding a production of 100 tonnes per annum ,or, in case of concern, also for substances at lower tonnages.

• This will involve around 5,000 substances corresponding to 15% of registered substances.

• Evaluation will be carried out by authorities and will include the development of substance-tailored testing programmes focussing on the effects of long-term exposure.

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Authorisation

• Authorisation of substances with certain hazardous properties that give rise to “very high concern”.

• Includes Carcinogenic, Mutagenic or Reprotoxic substances (CMRs).

• Authorisation requires authorities to give a specific permission before a substance can be used for particular purposes demonstrated to be safe.

• Number of substances is estimated at 1,400 (5% of registered substances).

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Role, Rights and Responsibilites of Industry

• Legislation already in place along the whole manufacturing chain allocating responsibility for the safe use of chemicals to manufacturers and users of chemicals.

• Directive 92/59/EEC on General Product Safety extends the responsibility to products intended for consumer use.

• Should not present unacceptable risks under normal or foreseeable conditions of use.

• This has not worked satisfactorily!

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Downstream Users

• Downstream users will be obliged to assess the safety of their products for that part of the life cycle to which they contribute.

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Data Generation - Downstream Users

• Current system only applies to producers and manufacturers (to test chemicals).

• Action 5A: Downstream users must assume responsibility for the safety of their products

• Action 5B: Industry should have responsibility for performing risk assessments. This will require the manufacturer or importer as well as the downstream user to carry out adequate risk assessment for substances and preparations.

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Information to the Public

• Full openness is essential if the public is to understand the intended benefits of the Strategy and to ensure that the Commission has addressed the public interest.

• EU citizens should have access to information about chemicals to which they are exposed.

• Information must be presented in a form that enables a person to understand the risks and develop a sense of proportion in order to make a judgement on the acceptability of those risks.

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Consumer ‘Right of Choice’

• Information should enable the consumer to make a judgement on whether alternative products on the market are more favourable in terms of their intrinsic properties and risks.

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Access to Information

• All stakeholders, including general public and SMEs (<250 workers) should have access to non-confidential information on the central database.

• Easy to use summaries for substances will promote use by the general public.

• Summaries will include

–short profile of hazardous properties

–labelling requirements and Community legislation, including authorised uses and risk management measures.

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Response to White Paper (1)

• UK Chemicals Industries Association (CIA)

–Supports the aims but does not believe the proposals to be practicable.

–Will damage the competitiveness of the EU chemical industry, especially SMEs.

–Paper is based on the premise that there are many dangerous chemicals being used in ways that pose a threat to human health or the environment.

–Reality is that there is no evidence of this.

–Must have an international level playing field, without this the economic and social consequences of the policy on European industry will be irreversible.

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Response to White Paper (2)

• European Chemical Industry Council (Cefic)

–Welcomed plans to develop a more transparent and workable chemical policy.

–Increased level of bureaucracy from Scheme will lead to ‘more testing on more animals using more animals.

–Concerned that the authorisation process may increase the number of chemicals that are ‘restricted or banned entirely’.

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Response to White Paper (3)

• Greenpeace, Friends of the Earth, The Danish Consumer Council, The Danish Association for the Conservation of Nature, The Danish Ecological Council

–All think that the Commission White Paper on Chemicals is too weak

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Stakeholder’ Conference

• Brussels, 2nd April 2001

• Organised by the European Commission to launch the new Chemicals Strategy as introduced in the White Paper and

• To gather input from key stakeholders on its implementation

• Two workshops

–first on implementing the policy

–second on stakeholders contribution

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Reinhard Reibsch from the European Mine, Chemical and Energy Workers’s Federation

(EMCEF) addressed role of Trade Unions

• Discussions important and necessary.

• Training, qualifications of workers critical.

• Social and human aspects are totally missing

–knock-on effects on number and quality of jobs is not addressed.

• Objective of sustainable chemicals policy must be the safe use of substances over their entire life cycle.

• Authorisation poses a real problem as it does not exist for our major non-EU competitors.

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EMCEF Continued

• Bans solely on the intrinsic properties are not acceptable

–Policy should include assessment of risks and benefits before bans are decided and risks attached to alternatives must also be addressed.

• Competitiveness not properly addressed, in particular as regards imported products.

• Chemicals and products produced in Europe must not suffer any disadvantages as compared to imports.

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Downstream Users (1)

• Downstream users would include lead crystal manufacturers.

• Many downstream users are SMEs.

• Lack of differentiation between manufacturers and downstream users in the policy.

• Costs could be excessive for downstream users and SMEs.

• Need for clear guidelines and easy/manageable procedures for downstream users.

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Downstream Users (2)

• Downstream users must take account not only the benefits and technical performance of the chemicals they use, but also their health and environmental consequences.

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European Chemicals Bureau

• Working on risk assessment of existing substances

• Four priority lists

1. May 1994 – 42 substances

2. September 1995 – 36 substances (ZnO)(NL)

3. January 1997 – 32 substances

4. October 2000 – 30 substances

No report on ZnO yet.

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What Goes to Make Lead Crystal Glass?

Chemical Formula (%) Chemical Name Source

SiO2 (62%) Silica Glassmakers Sand

PbO (24%) Lead Oxide Pb3O4, Litharge

K2O (9%) Potassium Oxide Potassium carbonate K2CO3

Na2O (3%) Sodium Oxide Sodium carbonate Na2CO3

B2O3 (1%) Diboron trioxide Boric Acid, B2O3.3H2O

As2O3 (1%) Diarsensic trioxide As2O3

Composition of a typical lead crystal glass

Mix ingredients, melt to 1400oC in a furnace overnight,cool to a working temperature of 1100oCGlass is a solid liquid!

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Glassmaking - CAS & EINECS

Chemical CAS No. EINECS No.

Glassmakers Sand, SiO2 112945-52-5 None

Pb3O4, Litharge 1314-41-6 215-235-6 (orange lead)

Potassium carbonate K2CO3 584-08-7 209-529-3

Sodium carbonate Na2CO3 497-19-8 207-838-8

Boric Acid, B2O3.3H2O 1303-86-2 215-125-8

Diarsenic trioxide, As2O3 1327-53-3 215-481-4

•CAS – Chemical Abstracts Service

•EINECS – European Inventory of Existing Chemical Substances

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Acid Polishing – CAS & EINECS

Chemical CAS No. EINECS No.

Hydrofluoric acid, HF 7664-39-3 231-634-8

Sulfuric acid, H2SO4 7664-93-9 231-639-5