EU Health & Safety Legislation Now and Tomorrow The European Cement Industry: a Health Perspective CEMBUREAU General Assembly Stockholm June 13, 2006 Ursula.

EU Health & Safety Legislation Now and Tomorrow

The European Cement Industry: a Health PerspectiveCEMBUREAU General Assembly

Stockholm

June 13, 2006

Ursula SchliessnerMcKenna Long & Aldridge LLP

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I. Introduction

Health related regulation is scattered in different areas:

Workers Safety

Chemicals*

Products**

* REACH; Classification, packaging and labeling of substances & preparations (Dir. 67/548, 1999/45: safety data sheets, chromium VI labeling); Marketing & Use Restrictions Directive 76/769 ( example: Chromium VI)

** Construction Products Directive 89/106 (Products must be safe for occupants, neighbors and other users, Annex I); Dir. 85/374 product liability; Dir. 2001/95 product safety)

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There is a large number of Directives* setting minimum requirements all based on the same principles.

II. Workers Safety Legislation

* Dir. 89/391 (base); Dir. 98/24 chemicals at work; Dir. 2004/37 carcinogens/mutagens at work (Binding limit values for benzene, vinylchloride monomer, hardwood dusts); Others (Dir. 83/477 asbestos at work; Dir. 2003/10 physical agents (noise); Dir. 89/655 work equipment; Dir. 2000/54 biological agents; Dir. 1999/92 explosive atmospheres; Dir. 94/33 on protection of young people at work; Dir. 92/104 workers in surface and underground mineral-extracting industries; and drilling 92/91; Dir. 92/85 pregnant, recently given birth, and breastfeeding workers; Dir. 92/58 safety & health signs at work; Dir. 92/57 temporary and mobile construction sites; Dir. 91/322 indicative limit values; Dir. 90/270 display screen equipment; Dir. 90/269 manual handling of loads (risk of back injury); Dir. 2006/15; Dir. 89/656 personal protective equipment; Dir. 89/654 workplace; and Recommendation 66/464 medical control)

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Principles of Workers Protection Legislation

Risk Assessment of specific work place (on the basis of safety data sheet, other available info, measuring)

Risk management if risk identified

Training & consultation Evaluation

Avoidrisks

Combat risks at source

Adapt work to individual

Replace dangerous by non or less dangerous

Develop coherent overall prevention policy

Collective measures take priority over individual measures (e.g. PPE)

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Examples of Risk Assessment and Risk Management (Negative)

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Examples of Risk Assessment and Risk Management (Positive)

Cables routed under the walkwayCables routed under the walkway

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Example of Risk Assessment and Risk Management (Negative)

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Example of Risk Assessment and Risk Management (Positive)

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Self-regulation may also be used in the workers safety area: so-called Social Dialogue

Member States may entrust Social Partners, at their joint request, with the implementation of Directives

Conclusion of Social Dialogue Agreements upon joint request (9 months suspension of legislative process)*

Experience:**Currently 31 sectoral Social Dialogue committees incl. construction, mining and chemicals. CEMBUREAU not member. Indirectly CEMBUREAU may be impacted because of its suppliers/customers. Very few Social Dialogue Agreements.

* Implementation possible by a) procedures/practices social partners and Member States, or b) Council Decision/Directive upon Commission proposal

** At earlier stages, agreements at horizontal level implemented by Council Directives (part-time work, parental leave , fixed-term work, etc.); now “autonomous” horizontal or sectoral agreements, e.g. stress at work (horizontal); telework (sectoral); vocational training in agriculture, working time in civil aviation; age diversity in commerce; telework in telecommunications sector

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CEMBUREAU participated along 14 other industry associations and two employee organizations (EMCEF, EMF) in negotiation of Social Dialogue Agreement on “Workers health protection through the good handling and use of crystalline silica and products containing it”

Novel because:• First Agreement on a substance

• First multi-sector Agreement

• First Agreement with parties not members of existing SD sector committees

• First Agreement directly applicable

• Very detailed (compared to existing SDAs)

• Extensive monitoring and reporting scheme

• Self-initiated (not in response to First or Second Stage consultation)

Silica

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III. Chemical Legislation

REACH will impact health protection, but changes will not be dramatic.

Increased supply of information

Less divergences

More record keeping

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Existing Requirements REACH Requirements

• Classification, packaging, labeling under Dir. 67/548 and 1999/45 of dangerous* substances and preparations

• Same – plus PBT and vPvB (Council);– plus substances eligible for authorization

(EP)– plus annex with exposure scenarios (with

related use and exposure categories, EP)

• Provision of safety data sheets (SDS) for dangerous substances and preparations and some non-dangerous preparations to professional users before or at first delivery

• Same

• Obligation to revise SDS and inform customers, and to notify new information on previously notified substances to MS

• Obligation to notify and update Agency on changes to – hazard classification– hazard label

“Classification and Labeling Inventory” If information supplied results in different entries of

the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the Inventory (Art. 110 REACH)**

Information in the Supply Chain (see following slides)

* 15 danger categories: explosive, oxidizing, extremely flammable, highly flammable, flammable, very toxic, toxic, harmful, corrosive, irritant, sensitizing, carcinogenic, mutagenic, toxic for reproduction, dangerous for the environment

** Art. 112 REACH: harmonized classification & labeling under Dir. 67/548 will continue only for carcinogenic, mutagenic or reprotox, cat. 1, 2 and 3, and respiratory sensitizers.

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Safety Data Sheets under REACH (current Dir. 2001/58)

1. Identification of the substance/preparation and of the company/undertaking

1.1 Identification of the substance or preparation

1.2 Use of the S/P1.3 Company/undertaking identification1.4 Emergency telephone

2. Hazards Identification

3. Composition/Information or Ingredients

(= all hazard information)

4. First Aid Measures

5. Fire Fighting measures

6. Accidental Release Measures

7. Handling and Storage7.1 Handling7.2 Storage7.3 Specific Uses

8. Exposure Controls/personal Protection

8.1 Exposure limit values8.2 Exposure controls

9. Physical and chemical properties9.1 General information9.2 Important health, safety and

environmental information9.3 Other information

10. Stability and Reactivity10.1 Conditions to avoid10.2 Materials to avoid10.3 Other information

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11. Toxicological information

12. Ecological information12.1 Ecotoxicity12.2 Mobility12.3 Persistence and

degradability12.4 Bioaccumulative potential12.5 Results of PBT

assessment12.6 Other adverse effects

13. Disposal Considerations

14. Transport information

15. Regulatory information

16. Other information(e.g. key data, training, recommendations on use restrictions)

ANNEX (NEW!):Exposure scenarios (based on chemical safety report, i.e. above 10 tons and subject to registration and dangerous/PBT/vPvB = Article 13 REACH)

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NOTE: SDSNOTE: SDS• TO BE PROVIDED IN NATIONAL LANGUAGESTO BE PROVIDED IN NATIONAL LANGUAGES• TO BE UPDATED (and sent even to previous TO BE UPDATED (and sent even to previous

customers of last year)customers of last year)• TO BE DATEDTO BE DATED• PERSONS in charge MUST BE REGULARLY PERSONS in charge MUST BE REGULARLY

TRAINEDTRAINED• To be made available to workersTo be made available to workers

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Information in supply chain when SDS not required

Registration number Details on authorizationDetails on restrictions “Any other available and relevant information about the

substance that is necessary to enable appropriate risk management measures to be identified and applied”

Info to be made available to workersTo be updatedAlso to previous (12 months) customers

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Record Keeping*Assembly and keeping of all information required to carry

out duties under REACH for at least 10 years after last manufacture, import, supply or use

This obligation is transferred in case of company transfer/cessation upon successor

Obligation upon manufacturers, importers, downstream users and distributors

Conclusion/consequence:Install a procedure

and a system !

* Article 33

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Conclusions REACH: Not so many changes for cement industry

Communicate in the supply chain

Change SDS

Install record-keeping system

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Legal Consequences from Failure to Comply with Information Requirements under REACH

National administrative / criminal law penalties/fines Criminal law sanctions in case failure can be considered a

negligent/intentional wrong-doing / omission leading to e.g. an injury / fatality

Damage claims under national toxic tort law if damage caused negligently by inaccurate / incomplete / lacking information that caused damage

Strict product liability if failure amounts to “defect” of a product Contractual liability in case supply contract provides for “compliance with

all applicable laws” Product recall under product safety legislation only in case of “consumer

products”

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IV. Product Regulation

Business as usual except for revision of Construction Products Directive

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V. Tomorrow Legislative/Regulatory Program

Adoption of REACH will lead to increased flow of information up and down supply chain, increased availability of information on substances and will therefore necessitate updating of work place risk assessments

Adoption of new Community program 2007-2012 on H&S at work will increase focus on multisource agents and risks, facilitate setting of limit values.

Revision of Construction Products Directive and standards may increase health and environmental standards of products

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OtherSectoral Social Dialogue as self-starter creating pressure on

human resources of associationsEmpty national health budgets to increase focus on

employer responsibility/liability for occupational diseases and accidents and more prevention

Aging workforce will create challenges also in terms of risk assessment and risk management at the work place

Large disparity in national H&S protection levels and within sectors. No level-playing field