Basics on chemical regulation - NanoValid: Home Basics on c… · Basics on chemical regulation 9 Personal protective equipment (PPE) Category I “Simple design”, directive 89/686/EEC

Developing Reference Methods for Nanomaterials

Presentation No 7

Basics on chemical regulation

Occupational safety and health in practice Example new technologies: nanomaterials

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Imprint

This presentation is a final product of the project NanoValid - project F2268 - and was generated under the lead responsibility of Miriam Baron (Federal Institute for Occupational Safety and Health).The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 263147 (NanoValid – Development of reference methods for hazard identification, risk assessment and LCA of engineered nanomaterials).The responsibility for the contents of this publication lies with the authors.

Copyright © 2015 by the authors

Project monitoring and main author: Miriam BaronFederal Institute for Occupational Safety and Health (BAuA)

With contributions from: Rolf Packroff, Michael Roitzsch, Dag Rother, Aart Rouw, Torsten WolfFederal Institute for Occupational Safety and Health (BAuA)

Shashi SinghCentre for Cellular & Molecular Biology

Damjana DrobneUniversity of Ljubljana

Figures: Miriam BaronFederal Institute for Occupational Safety and Health (BAuA)

Fox / Uwe Völkner

Project support:Elke Kahler-Jenett, Katharina NiesmannFederal Institute for Occupational Safety and Health (BAuA)

Design: Carolin Schneider, eckedesign Berlin

Editing:Johanna Ebbeskotte, Markus FlenderFederal Institute for Occupational Safety and Health (BAuA)

Publisher: Federal Institute for Occupational Safety and Health (BAuA)Friedrich-Henkel-Weg 1-25, 44149 Dortmund, GermanyNöldnerstr. 40-42, 10317 Berlin, GermanyTelephone +49 231 9071-0www.baua.de

NanoValid:Project Coordinator: Rudolf Reuther, Nordmiljö [email protected] +46 563 92253 (Sweden) or +49 170 7011534 (Germany)www.nanovalid.eu

All rights reserved, including photomechanical reproductionand the reprinting of extracts.

First published: July 2015

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Slide 1:

For chemical safety as well as for occupational safety and health, risk assessment plays a very important role.

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Slide 2:


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Adverseeffects

of substancesto human health

Exposure

to substancesat the workplace

Risk characterizationRisk assessment

Risk assessment

Risk management

� Two columns are the starting point for evaluation of risk management for operations with chemical substances and mixtures and for operations, which may lead to chemical exposure.

� On the one hand, there is the route, duration and level of exposure at the workplace. � On the other hand, there are the possible adverse effects to human health, which may be caused by skin contact

or inhalation of released substances or mixtures (hazards) � With this information the risk for a specific operation or workplace can be characterized. � Within risk assessment the risk information is assessed against the need for additional control measures for ad-

equate health protection. For example, a measured exposure level is compared with an Occupational Exposure Level (OEL). For risk assessment we need societal standards for an acceptable risk. These standards may differ from country to country.

� The results of risk assessment may lead to needs for risk management, which have to follow national regulations for chemical safety and occupational safety and health.

� Risk management is mandatory for occupational operations with chemical substances and mixtures, even if they are handled in laboratories or pilot plants. There are no derogations for research and development. It also has to cover articles with a potential for release of chemical substances or mixtures, e.g. machinery like a chainsaw with diesel exhaust.

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Slide 3:


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European regulation for chemical safety

Placing chemicalproducts on theinternal market

Art. 114 TFEU* (obligatory)REACH

CLP(GHS)-orderRegulation for product

lines

Occupational safety

Consumer safety

Environmental safety

Art. 153 TFEU*

Art. 169 TFEU*

Art. 191 TFEU*

Minimum standards

* Treaty on the Functioning of the European Union

� There are different areas of legislation in the EU which cover chemical safety issues. � Regulations for placing on the EU market address all participants, those who produce, import or supply chemical

substances or mixtures. Some duties start long before actors earn money by selling a chemical product, e.g. if they send a free material sample to another lab. These regulations are harmonised in all EU member states!

� These EU regulations are complemented by directives and other obligations (e.g. social partner agreements) for occupational safety and health, consumer and environmental safety. National legislation may differ, there is gen-erally no EU harmonization. For example, an occupational exposure level in member states may be different for the same substance. Also responsibilities may be different, occupational safety and health provisions are usually assigned to the employer.

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Slide 4:


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EU-Domestic market law

C lassification

L abelling

P ackaging

R egistration

E valuation

A uthorisation of

Ch emicals

Hazard Risk

� Chemical Safety in the EU is based on two fundamental regulations: the CLP (GHS) regulation and the REACH regulation.

� The CLP regulation requires the producer or importer to classify the substance or mixture based on the world-wide criteria of the “Global Harmonised System” (GHS) based on available information. If one or more of criteria are met, he has to label and to submit a safety data sheet (SDS) to industrial and professional users.

� There is no lower limit of production volume for these duties! � The REACH regulation includes additional testing and information requirements for producers and importers

of chemical substances, depended on their production volume. A registration procedure at European Chemical Agency (ECHA) is the core of the regulation. Until 2018 every chemical substance with a production volume above 1 ton per year has to be registered for their uses along the supply chain. Information on safe handling and uses has to be generated and communicated in an extended safety data sheet (eSDS).

� The REACH regulation allows ECHA and member state authorities to request further information to enable a com-prehensive risk assessment of a registered substance (substance evaluation) and to identify substances of very high concern (SVHC), which may be restricted or may require an authorisation for specific uses.

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Slide 5:


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Chemicals with specific regulatory demands

plant protecting agentsbiocidal products

food additivesanimal feed additives

pharmaceutical productscosmetics

� For some groups of chemicals specific regulations introduce additional requirements on authorisation, testing and provision of information along the supply chain with regard to their potential of harm for man and environ-ment.


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Slide 6:


Communication along the supply chain of chemicals

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REACH

producer/importer

eSDS

exposure scenario

Chemical Agents Directive(98/24/EC)

risk assessment

employer/employees

protective measures

Effectiveness

� The safety label and the SDS are the most important information sources for employers to comply with their du-ties for risk management in occupational safety and health. They are also important for employees to be aware of chemical hazards at their workplaces.

� For registered substances the eSDS describes safe working procedures (exposure scenario), which have to be adopted by the employer to specific operations and national occupational safety and health requirements.

� The chemical agents directive 98/24/EC sets minimum requirements for protection of workers against chemical exposure, national regulations may impose higher standards.

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Slide 7:


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STOP-Principle

STOP

Substitutionby less hazardous products, low-emission forms or processes

Technical measuressetting/design of operation, work equipment as state-of-the-art

Organizational safety precautionse.g. reduce time of exposure

Personal protective equipmente.g. respiratory protection, chemical protective gloves

� According to EU occupational safety and health directives, the employer has to follow a hierarchy of controls in risk management: the STOP principle with following steps:

� 1. Substitution of a hazardous substance or operation with substances or operations, which pose lowers risks to workers health and safety.

� 2. Technical protection measures at the source of emission: closed systems, local exhaust ventilation � 3. Organizational protection measures: segregation of operations, minimizing duration of exposure � 4. Personal protective equipment as a last resort: respiratory protection devices, chemical resistant gloves

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Slide 8:


Useful for dry, hazardous to health, non combustible dust,since 01.01.2005

Valid dust classes according toEN 60335-2-69, appendix AA

Dust class Maximum penetrationdegree

With OEL > 1 mg/m3 Minimum L (M,H) < 1 %

With OEL ≥ 0,1 mg/m3 Minimum M (H) < 0,1 %

With OEL < 0,1 mg/m3

Cancerogen hazardous substances accordingto hazardous substances ordinance§ 11, TRGS* 905 / TRGS* 906

H < 0,005 %

H < 0,005 %

Asbestos according to TRGS* 519 H + ability for use accordingto TRGS* 519

< 0,005 %

Additional use for combustible dust out of all dust explosion classes (except dust with extrem low minimun ignition energy MIE < 1 mJ)

Minimum LWith additional test according to EN 60335-2-69, appendix CCDevices of type of construction Zone 22

Reference: http://www.dguv.de/medien/ifa/de/pra/staubklassen/staubkl.pdf* TRGS: German Technical Rule for Hazardous Substances, http://www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/TRGS/TRGS.html

Dust categories for deduster, hoover and vacuum cleaner

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� Technical protection measures must be adapted for exposure reduction to specific operations or workplaces. � For industrial vacuum cleaners, commercial sweepers and the dust removers performance criteria are laid down

in the CEN standard EN 60335-2-69. � The standard defines three dust classes: low, medium and high. For selection you may refer to an overview from

the Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) which is shown here.

� For selection you need an occupational exposure limit for the corresponding substance or mixture, which can be taken from the SDS.

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Slide 9:


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Personal protective equipment (PPE)

Category I “Simple design”, directive 89/686/EEC article 8(3) Basic hygiene, e.g. laboratory coat, dish-washing glovesManufacturer declares conformity

Category II Neither simple nor complex, not in the exclusive lists Foot gear, work safety helmets, hearing protectors examined by the manufacturer and notified body, conformity is declared

Category III “Complex design”, directive 89/686/EEC article 8(4) PPE against fatal risks or serious and irreversible health injuries, e.g. respiratory protection, chemical protective clothing and glovesCE-label, in addition 4-digit number (identification number of the inspection (certifying) authority)

� If substitution is not possible and technical or organizational protection measures are not sufficient for protec-tion, personal protective equipment (PPE) has to be used.

� PPE can be divided into three categories. These categories are defined acc. to directive 89/686/EEC on personal protective equipment:

� Category I is the so-called “simple design”. This is the personal protective equipment defined in article 8(3) of the directive. This equipment contributes to the basic hygiene, for instance a laboratory coat or gloves, which protect against diluted detergent solutions (“dish washing gloves”). The manufacturer only declares the conformity and labels the product with the “CE” sign.

� Category II is neither simple nor complex. This personal protective equipment is not listed in the exclusive lists of article 8 of the directive. It is examined by the manufacturer and also by a notified body. Then the conformity is declared. Examples are safety footwear, work safety helmets or hearing protectors.

� Category III refers to a so-called “complex design”. This is the personal protective equipment defined in article 8(4) of the directive. This personal protective equipment shall protect against mortal risks or serious and irreversible health hazards. Examples are respiratory protection devices, chemical protective gloves or personal protective equipment against fall from the height. The equipment in this category has to be labeled with a 4-digit-number, which is the identification number of the certifying authority. The quality assurance procedures are defined in article 11A and 11B of the directive (EC quality control system).

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Personal protective equipment (PPE): respiratory protection

Respiratory protection devices

Isolation devices: Independent with air-

supply system Portable or not portable Applied if outside

concentration higherthan maximumadmissible filterconcentration

Filter devices: Dependent with filter1. Filter attached or not2. Filter with air-blower

or not3. Particle filter class

P1, P2 or P3

Figure: PAPR(power air-purifying respirator), Brandau-Pollack (BAuA)

� Respiratory protective devices shall protect against inhalation of hazardous substances or oxygen deficiency. � Respiratory protective equipment can either be self-contained breathing apparatus (isolation devices) with an

air-supply system or dependent on the environmental air (filter devices) with a filter unit. � Isolation devices are divided in portable and not portable devices. They have to be used if the oxygen concen-

tration is lower than 17 % or if the outside concentration of pollutants is higher than the maximum admissible concentration of the filter device.

� Filter devices can also be divided in three groups. There can be distinguished depending on 1) if the filter can be detached or not, 2) if the filter piece has an air blower and, 3) for particle filters, in the particle filter classes P1, P2 and P3 (low, middle and high separation capacity).

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Slide 11:


Type Meaning

1 Gastight

2 Ventilated, but not gastight3 Liquid chemicals (liquid-tight)4 Liquid chemicals (spray-tight)5 Solid particles and aerosols6 Limited spray-tight

Personal protective equipment (PPE): chemical protectivesuits

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� There are six types of chemical protective suits. � Type 1: are gastight (EN 943-1) � Type 2: are ventilated, but not gastight (EN 943-1) � Type 3: for liquid chemicals (liquid-tight, EN 14 605) � Type 4: for liquid chemicals (spray-tight, EN 14 605) � Type 5: for solid particles and aerosols (ISO 13 982) � Type 6: limited spray-tight (fulfils the requirements of the reduced spray test, EN 13 034)

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Slide 12:


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Personal protective equipment: chemical protective gloves

Penetration Solid, liquid or gaseous substances pass through macroscopic holes (seams or defects)

Permeation Solid, liquid or gaseous substances pass in the molecular range

Degradation Deterioration of the material caused by the effect of chemicals

� There 3 material related criteria, which have a significant impact on the protective effect of gloves against chemi-cals:

� Penetration: solid, liquid or gaseous substances pass through macroscopic holes (seams or defects) resulting from the working conditions (e.g. sharp edges)

� Permeation: solid, liquid or gaseous substances pass in the molecular range depended on the kind of material and the thickness of the glove and the substances used.

� Degradation: is the deterioration of the material caused by chemicals, e.g. acids or solvents

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Slide 13:


Code letter

Testing chemicalproduct

Class

A Methanol Primary alcohol

B Acetone Ketone

C Acetonitrile Nitrile

D Methylene dichloride Chlorinated paraffin

E Carbon disulphide Sulphurous organiccompound

F Toluol Aromatic hydrocarbon

G Diethylamine Amine

H Tetrahydrofuran Heterocyclic and othercompound

I Ethyl acetate Ester

J N-heptane Aliphatic hydrocarbon

K Sodium hydroxide 40 % Inorganic base

L Acid sulphur 96 % Inorganic acid

Permeationlevel

Permeationtime [min]

Class 1 > 10

Class 2 > 30Class 3 > 60Class 4 > 120Class 5 > 240Class 6 > 480

References:

http://publikationen.dguv.de/dguv/pdf/10002/i-868.pdf

http://www.haufe.de/arbeitsschutz/arbeitsschutz-office/chemikalienschutzhandschuhe-2-arten-von-chemikalienschutzhandschuhen_idesk_PI957_HI2643201.html

Personal protective equipment: chemical protective gloves

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� Protective gloves can be divided in simple and fully adequate protective gloves, which can be recognized by the pictograms “beaker” or “Erlenmeyer flask”.

� Below the pictogram, an identification letter (12 test chemicals from A to L) shows to which chemical the glove provides adequate protection.

� The permeation level indicates the permeation resistance of the gloves, ranging from less than 10 min (class 1) to more than 8 hours (class 6).

� A fully adequate protective glove protects at least for 30 minutes (class 2) against three of the 12 test chemicals. � However, it is essential to read the instruction for use or to ask the supplier for tailored information for a specific

substance, mixture or operation. � Also consider workers allergies when choosing glove materials. � Wearing gloves is wet work! Wear additional thin cotton gloves. Do not work longer than 4 hours with gloves. Be

aware of skin care.

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Slide 14: Thank you!


Thank you for your attention!

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Basics on chemical regulation - NanoValid: Home Basics on c… · Basics on chemical regulation 9 Personal protective equipment (PPE) Category I “Simple design”, directive 89/686/EEC