REACH R egistration E valuation A uthorisation of CH emicals

October 2006 ICF Technical Exchange Conference 1

REACH

Registration Evaluation Authorisation of CHemicals

Michael J. HynesDepartment of Chemistry

National University of IrelandGalway


The EU Approach !

• EU Legislators “have a predisposition to legislative action” even when no problem exists.

• An ombudsman needed to screen all new proposals to prevent laws being passed that were simply “solutions in search of problems”.

• Much of the EU legislation is “paper proposals” that does not offer benefits.

• Michael McDowall (Irish Minister for Justice)


Outline of presentation

1. REACH key elements

2. Claimed benefits

3. Glass

4. Appendix 1 synopsis (my ICF submission)

5. Conclusions


What does REACH regulate ?

• The manufacture, import, marketing and use of chemicals.

• Need to REGISTER each chemical produced or imported at more than 1 tonne per year.

• Member states will EVALUATE the information provided in the registration phase.

• Substances of high concern will be subject to AUTHORISATION. (Sunset date)

• Substances that cause– Cancer, genetic mutations or birth defects (CMRs) as

well as substances that are persistent, bioaccumulative and toxic (PBT & vPvB)


Exemptions under REACH

• Pharmaceuticals, pesticides, radioactive materials (regulated under other laws).

• Substances in transit through Europe.• Non-isolated intermediates.• Substances formed as byproducts or that result

from incidental reaction (sunlight).• A variety of substance e.g. oils, fatty acids,

natural gas, crude oil and coal.• Minerals, ores or substances occurring in nature

are exempt if they are not chemically modified during their manufacture and are not dangerous.


What does REACH cover ?

• REACH deals with SUBSTANCES ONLY and not preparations or articles.


Definitions – Substance, Preparation

• Anything we call a chemical in ordinary conversation is a substance or a preparation under REACH.

• Substance – a single chemical (an element and its compounds either natural or manufactured.– Carbon is a substance (an element)– Calcium Carbonate is a substance because it

is a single compound.• Preparation – a mixture or solution containing

two or more substances.– Paint is a preparation.


ARTICLE

• Any object produced by industry that is not a substance or a preparation is an article.

• Anything that has been given a specific shape, surface or design during production, so that it can be used for a specific purpose.

• Computers, books, toys, cars are all articles.• Some of the chemicals in an article may be harmful to

environment and health.– If such a substance is released intentionally as part of

the function of the article, it will need to be registered– e.g. ink in print cartridge


Downstream User

• A company that buys chemicals and uses them in a product.

• Most manufacturers and formulators are downstream users.

• Hairdressers are downstream users.

• Crystal glass manufacturers are downstream users of chemicals.


The REACH System

Registration Evaluation Authorisationof CHemicals

Manufacturers, Importers and Downstream Userswithin the EU are subject to REACH

Crystal glass industry is a downstream user – REACH applies


The REACH System – Main Goals

• Improved knowledge about the (hazardous) properties of substances on the European Market

• Polluter-Pays-Principle• Contribution to innovation

– Equal treatment of New Substances and Existing Substances

• Transparency along the whole supply-chain• Consumer Protection


Aims of White Paper of June 2001

• Protection of human health and the environment.• Maintenance and enhancement of the

competitiveness of the EU chemical industry.• Prevention of fragmentation of the internal

market.• Increased transparency.• Integration with international efforts.• Promotion of non-animal testing.• Conformity with EU international obligations

under the WTO.


How Does REACH Work

Substance (Chemical)

Extremely Hazardous*?

Yes

Authorisation

No

RegistrationEvaluation

> 100 t/year

* CMR, Carcinogen, Mutagen, Reproductive Toxicant

1 t/year

INTRINSIC PROPERTIES

TONNAGE BANDS


REACH is based on quantity

• REACH should be based on risk• Intrinsic hazard not a good measure of risk• Risk is a better measure as it is based on the

likelihood that an intrinsic hazard associated with a substance will cause actual harm.

• While REACH replaces up to 40 Directives and Regulations, it leaves more than 20 others in place.

• REACH should only require data that is of real value.• The ‘best’ and ‘safest’ chemicals should not be

withdrawn simply because they generate insufficient profit to cover the cost of testing.


Is REACH Necessary ?

• Depends on your point of view !!• Problem of existing substances on market before

September 1981 (EINECS)• EINECS lists about 100,204 substances when it was

compiled (Substances on EU market between January 1971 and 18 September 1981)

• Little Risk Assessment done on these– 30,000 substances on market above 1 tonne/pa– Have an unfair advantage in the marketplace– No impetus to replace them– Only the 30,000 need to be Registered

• Council Regulation 793/93/EEC really did not work.– Small number of substances risk assessed.


Withdrawal of Chemicals from Use

• REACH is expected to result in some withdrawal of chemicals from the market.

• Estimates for this vary widely– the Commission has given estimates of 8-12

percent of chemicals from production or use.• Withdrawal of a chemical can have very

serious repercussions.


But lots of existing legislation

• Up to now now, Directive 67/548/EEC has been amended nine times, the ninth amendment being Directive 1999/33/EC and adapted to technical progress (ATP) twenty eight times, the 28th being Directive 2001/59/EC.

• 76/769/EEC of 17th July 1976 [4] on restrictions of the marketing and use of chemicals (the so-called Limitations Directive) which is used to restrict or prohibit the marketing and use of certain chemicals which cause unacceptable risk to human health or the environment

• Biocides directive 98/8/EC– which has sounded the death knell for the Irish wake– prospect of a ban on formaldehyde used to embalm bodies.– The cost of evaluating formaldehyde, estimated to be €6 million

will prove uneconomic for a relatively small industry manufacturing formaldehyde.


Integrated Pollution Prevention and Control

• While some member states had implemented a system of Integrated Pollution Prevention and Control (IPPC) prior to its implementation, Directive 96/61/EC made this mandatory.

• The concept of best available technology (BAT) was introduced.

• The original IPPC directive has been amended twice.• The first amendment reinforced public participation in

line with the Aarhus Convention while the second clarified the relationship between the permit conditions established in accordance with the IPPC Directive and the EU greenhouse emission trading scheme.

• The Commission is currently carrying out a review of the IPPC Directive and related legislation on industrial emissions, over the period 2006-2007.


National Authorities

• The National Authorities in the member states have in many instances enacted additional legislation regulating the use of chemicals in the workplace in the form of Safety, Health and Welfare at Work legislation and the subsequent sale or disposal of chemicals.

• Furthermore, industries using chemicals are continually being monitored by pressure groups such as Greenpeace, Friends of the Earth and the World Wildlife Fund (WWF).


International Programme on Chemical Safety

• International Programme on Chemical Safety (IPCS) established in 1980 is a joint programme of three reputable cooperating organisations– World Health Organisation (WHO)– International Labour Office (ILO)– United Nations Environment Programme (UNEP).

• Has a very comprehensive library of methods for chemical assessment.

• In order to utilise the best use of limited resources, the IPCS in collaboration with the Organisation for Economic Cooperation and Development (OECD) have already developed a framework for cooperation in the field of risk assessment methodologies (http://www.who.int/ipcs/en/)

http://www.who.int/ipcs/en/




REACH becomes a reality

• On 13th December 2005 following a marathon vote on over 1,000 amendments, REACH was approved by the European Parliament.

• A second reading of the proposal is due in 2006 and REACH should enter into force in late 2006 or early 2007.

• This will result in a phased 11-year programme for mandatory registration of around 30,000 substances.

• REACH will transfer the burden of proof from authorities to industry for testing and risk assessment of chemicals.


Phasing in of REACH

Deadline (years) Phase-in Substance

3 Carcinogens, Mutagens, Toxic to Reproduction (CMRs) Cat. 1 & 2

3 N; R50-53 and >100 tonne per year

3 > 1,000 tonne per year

6 > 100 tonne per year

11 > 1 tonne per year

R50 – R53 refer to toxicity to aquatic environment


Current Version

• Common policy as of 12 June 2006– Runs to 673 pages

• REACH Regulation (December 2005) runs to 270 pages.


Registration

• All substances produced or imported in quantities of one tonne or more per annum will have to be registered in a central database operated by the new EU Chemicals Agency (ECA) submitting information on properties, uses and safe ways of handling them.

• Registration is not required for substances produced or imported in quantities less than one tonne, substances for use in research activities and polymers.

• Information required will be proportional to production volumes and risk.

• European Chemicals Agency will be based in Helsinki.


Evaluation

• Two type of evaluations:• Dossiers and Substances.• Competent authorities in member states can

carry out evaluations of substances when they have justified reasons that there is a risk to human health or the environment.


Authorisation

• Use-specific authorisation will be required for ‘problematic’ substances.

• These would include substances which were carcinogenic, mutagenic or toxic to reproduction (CMRs), substances which were persistent, bio-accumulative or toxic (PBTs) and substances which were very persistent and very bio-accumulative (vPvPs) and other substances with serious and irreversible effects on humans and the environment.

• Authorisation will be provided to these substances if:– the risks can be adequately controlled or – on valid socio-economic grounds if there are no

technological alternatives (i.e. ‘Benefit’ considerations).

• Sunset date after which they can not be used.


Restrictions

• The Commission will continue to be able to restrict the use of certain dangerous substances at EU level, but REACH will introduce ‘cleaner’ procedures and allow for decisions to be taken more quickly than in currently the case.


Costs to Downstream Users

• The European Commission estimates the costs to downstream users of chemicals at €2.8 – 3.6 billion if the market behaves as expected with 1-2 % of substances withdrawn because continued production would not be profitable.

• Costs could rise to €4 – 5 billion if industry faces higher supply chain adaptation costs.

• These estimates include the direct costs passed on from the chemicals sector to downstream users.


Total Costs

• The latest estimate of the overall costs to the chemical industry and its downstream users are estimated to be €2.8 – 5.2 billion [9] and are claimed to be ‘managable’.

• However, these costs could be subject to a considerable underestimate.

• For example, the cost of chemicals will increase across the board as a result of REACH.

• Secondly, the withdrawal of some chemicals will result in users having to switch to higher cost alternatives.

• Arising from this there will be significant additional costs arising from producers having to modify production processes and reactions as a result of these supply chain adaptation costs.


Pharmaceutical

• Pharmaceutical manufactures will have greatly increased costs as they operate under current good manufacturing practice (cGMP) regulations and any changes to the production process such as replacing/substituting raw materials will result in them having to revalidate and comply with their change control procedures.


Europe

• This is most unfortunate from a European point of view as chemical production is one of the few manufacturing area in which we outperform the US.

• European enterprises produce 31 % of the world's chemicals with the US producing 28 %.

• The EU's chemicals industry is the third largest manufacturing industry generating 1.7 million jobs and indirect employment for more than 3 million people.


A reminder of the costs of REACH

• Estimates of the costs of REACH vary enormously

• Latest EU costs state:– Euro 2.3 billion for producers– Euro 5.2 billion for downstream users


Claimed benefits of REACH

• Monday 17th October 2005• Report from EU Trade union body Etuc and

hosted by Guido Sacconi (EU rapporteur for REACH)

• Research was carried out at University of Sheffield (UK).

• Focused on asthma, dermatitis, chronic pulmonary disease (short term effects of chemicals) rather than cancer (long term effect) as in previous studies


Health Benefits of REACH

• Etuc Report• First 10 years

– €0.66 – €6.2 billion (€ 3.5 billion median)• Over 30 years

– €21 – €161 billion (€90 billion midpoint)• Commission Estimates (RPA report)

– €27 billion over 30 years


Claimed Benefits of REACH

• The European Commission claim that positive occupational impact and public health impact of REACH is expected as chemicals are linked to respiratory and bladder cancers, mesothelioma, skin disorders, respiratory diseases, eye disorders, asthma.

• Increased information on hazards and controls will assist in better implementation of existing legislation.

• The latest fact sheet claims that if REACH succeeds in reducing chemical-related diseases by only 10%, the health benefits are estimated at €50 billion over 30 years.


Glass in REACH


Are fluid glass mass and solid glass products substances, preparations or

articles under REACH?

• Fluid glass mass which is produced during the manufacture of glass is a preparation that would render glass comparable to metal alloys.

• Those substances in fluid glass mass which are minerals and are not chemically modified during the process do not need to be registered (??).

• Other substances used e.g. as glass modifying agents, colouring/decolouring agents, coating agents, etc need to be registered.


Preparation → Article

• The glass– becomes an article when it has been given its

final shape (e.g. a bottle, glass), but – remains a preparation if it cools to a glass

mass for further processing.• I imagine that engraving would be considered

further processing as would cutting and polishing.


What about sand?

• Sand: CAS#: 14808-60-7 EC#: 238-878-4• Sand is listed in EINECS.• Sand would be treated as a mineral and as such would

be exempt from registration unless it was further modified – but removal of impurities allowed?

• Much of the sand used in lead crystal manufacture is chemically modified to remove impurities such as iron and as such, it appears to me that it would not have to be registered.

• ESIS: Not listed in a priority list (as foreseen under Council Regulation No. 793/93) and is not classified in Annex 1 of Directive 67/548/EEC (ESIS - European chemical Substances Information System


Other components in glass manufacture

• Everything else used in glass manufacture is a substance and as such would have to be registered.

• Some substances will cause problems– Lead oxide– Arsenic oxide (As2O5 and As2O3) (R45 – may

cause cancer)– HF (RAR published – has identified glass

manufacture as a source of exposure)

RAR - Risk Assessment Report (under Directive 793/93)


Aspects of US Concern


REACH – a costly, burdensome and complex approach

• The US shares the EU interest in regulating chemicals with a view to reducing or eliminating adverse health and environmental effects.

• However, it is very concerned “that the European chemical regulations appear to adopt a particularly costly, burdensome and complex approach, which could prove unworkable in its implementation, adversely impact on innovation and disrupt global trade”.

• The concerns of the US are understandable in that the new regime could affect the majority of US goods exported to the EU which amounted to $143 billion in 2002.

• The main points raised by the US are as follows.


General points of US concern

• Costs are upfront – benefits will come much later.• Commission’s proposal imposes a stringent regulatory

regime on thousands of chemicals that pose little risk to man or the environment– Evaluation is tonnage based rather than risk based – Echoed by RSC in submission to UK Parliament

(mention sodium chloride!)• Resource problem – lack of testing capacity in the EU

– note lack of progress on Council Regulation No. 793/93


Departs from International Regulatory Cooperation

• Commission’s approach in developing its proposals has departed from the ongoing OECD cooperation.

• Commission’s proposals could undermine other programs– OECD Screening Information Data Set (SIDS)– ICCA HPV initiative (International Council of

Chemical Associations High Production Volume)


Imposes substantial costs with uncertain benefits

• Costs are substantial• No account taken of effects on

– Prices– International competitiveness– Employment


Adversely Impacts on SMEs

• Small manufacturers account for the majority of EU chemicals and US industry– Face disproportionate costs– Some may simply exit the EU market

• Must find ways of reducing the regulatory burden for SMEs.

• European Chemicals Industry Council (CEFIC) estimate that 20% of chemical industry will carry 80% of costs of REACH– Mainly SMEs working on fine and speciality chemicals

at low production volumes (430,000 people across the EU)


Disrupt Global Trade and Supply Chains

• Risk & Policy Analysts (RPA) state that there are 500,000 – 5 million different article types on EU market

• An average of 10 – 50 substances per article• Proposals impose burdensome analytic and reporting

and administrative requirements on downstream users – especially overseas manufacturers.

• Downstream users worried that approach will disrupt global supply chains.– Manufacturers will just halt production when

demand does not justify registration and testing costs.


Adversely Impacts Innovation

• Commission’s own assessment (RPA report) states that impacts on innovation are expected to be negative in that both money and expertise devoted to product development will instead be focussed on gathering and evaluating data on low-risk substances.

• Chemicals R&D innovation and introduction of new substances will occur increasingly outside the EU (India and China in particular).


Creates Market Uncertainty

• Regulation does not provide sufficient information as to how decisions will be taken regarding the regulatory treatment of various chemicals.– Member state authorities, the Commission,

the ECB all involved!• Lack of clarity will produce uncertainty in the

market– This will also affect downstream users


Unclear Administrative Coordination and Consistency

• Central Agency (ECB), EU member states and the Commission all responsible for action.

• Coordination problems will lead to uncertainty.

– The one thing a business can not tolerate is uncertainty !


Concerns regarding consortia and data sharing


REACH Implementation Projects (RIPs)

• RIP 1: Process descriptions

• RIP 2: Development of IT systems (REACH-IT)

• RIP 3/4: Guidance Documents

• RIP 5/6: Setting up the European Chemicals Agency


3.1: Preparing theregistration dossier

3.1: Preparing theregistration dossier

3.2: Preparing the CSR

3.2: Preparing the CSR

3.3: Information requirements

3.3: Information requirements

3.10: Guidance on substance ID

3.10: Guidance on substance ID

3.5: Guidance for downstream users

3.5: Guidance for downstream users

3.8: Requirementsfor articles

3.8: Requirementsfor articles

3.6: Guidance onC&L under GHS

3.6: Guidance onC&L under GHS

3.7: Guidance on applications for authorisation

3.7: Guidance on applications for authorisation

3.9: Guidance on SEA

3.9: Guidance on SEA

3.4: Guidance on data-sharing

3.4: Guidance on data-sharing

RIP-3Guidance for

Industry

Downstream Users

SEA = Socio Economic AnalsisGHS = Globally Harmonised System


Banana Skins in front of Crystal Industry

• Lead oxide not on a priority list as yet• But• Appendix 5 – Point 30

– Toxic to Reproduction: Category 1– Refers to lead compounds with the exception

of those found elsewhere in this annex


Arsenic

• Appendix 1 – Point 28– Carcinogens: Category 1– Diarsenic trioxide, arsenic trioxide

• Shall not be used in substances and preparations placed on the market for sale to the general public in individual concentration equal to or greater than:– either the relevant concentration specified in

Annex I to Directive 67/548/EEC, or the relevant concentration specified in Directive 1999/45/EC.


Conclusion for Crystal Industry

• Crystal industry largely a downstream user of chemicals.

• A considerable amount of the work required will be done by suppliers of the chemicals used.

• However industry will have to put Risk Management Measures (RMMs) in place.

• One can see the problems faced by users of lead compounds in the context of the CMR and/or vPvB assessment.

• Some chemicals could be subject to authorisation, restricted use or total bans.


Simplified workflow: check of SDS/ES (new)

Check SDS/ES

Use Covered ?

Comply with ES ?

OK

Make use/ use conditions known

Find alternative supplier

Make DU CSA (+write CSR)

Implement suppliers ES

Conditions in place meet at least conditions in suppliers ES

No

No

No

Yes

Yes

Yes


Regulations/Directives replaced by REACH (1)

• Council Regulation 793/93/EEC on the evaluation and control of the risks of existing substances.

• Commission Regulation 1488/94/EC laying down the principles for the assessment of risk to man and the environment of existing substances in accordance with Regulation 793/93.

• Council Directive 73/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations.



• Commission Directive 91/155/EC defining and laying down the details arrangements for the system of specific information relating to dangerous preparation in implementation of Article 10 of Directive 88/379/EEC.

• Commission 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.



• Commission Directive 93/105/EC laying down Annex VIID, containing information required for the technical dossier referred to in Article 12 of the seventy amendment of Council Directive 67/548/EEC.

• Commission Directive 2002/21/EC concerning the list of Community legislation referred to in the fifth indent of Article 13(1) of Council Directive 67/548/EEC.

• In addition, Directive 1999/45/EC concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, will be amended.

REACH R egistration E valuation A uthorisation of CH emicals

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