HomeMy WebLinkAboutREACH - NAS .h
NASMAIM
KENTUCKY EXCELLENCE
IN ENVIRONMENTAL
NORTH AMERICAN STAINLESS LEADERSHIP
6870 Highway 42 East Phone: (502)347-6000
Ghent, KY 41045-9615 Fax: (502)347-6607
Jan 20, 2023
RE: REACH Conformity
On June 1, 2007, major new legislation entered into force in the European Union ("EU"),
dramatically overhauling the system for regulating chemicals, including chemicals in mixtures
and articles, that are manufactured or imported into Europe. Known as "REACH" — the
Registration, Evaluation, and Authorization of Chemicals — the legislation imposes substantial
requirements on companies to register and provide health risk information on chemicals
manufactured in Europe or imported in excess of one metric ton per year. In essence, the
regulatory system requires chemical manufacturers and importers to prove the safety of a
substance before being allowed to place it on the market.
NAS confirms that all stainless steel products supplied are articles and comply with REACH
obligations.
NAS has reviewed the January 2023 Candidate listing of Substance of Very High Concern
(SVHC). We can confirm that our product does not contain SVHCs included in the ECHA
(European Chemicals Agency) Candidate List in a concentration above 0.1%by weight.
Information about the safe use of products is available to our customers. In accordance with
REACH and CLP Regulation, articles under REACH Article 32 are to be accompanied by
sufficient information to permit safe use and disposal. Please the attached Safety Information
Sheet. The NAS Safety Data Sheet is available on our website. NAS continues to review
material safety data sheets (and Safety Information Sheets) for materials used at NAS as means
of REACH conformity.
Sincerely,
leaLD
Maria Eichelberger
Environmental Manager
North American Stainless
Attachment
/ ACERINOX SIS
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ACERINOX Safety Information Sheet p too�rmelue:05May2016
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1:INTRODUCTORY INFORMATION 2.3.-Article composition:
Stainless steel products are considered as Stainless steels Stainless steels are iron alloys
artides under the REACH Regulation that contain more than 10.5% chromium and less
(1907/2006/EC), a position adopted by all than 1.2% carbon. Composition below is given in
European stainless steel producers as weight percentages.
presented in the EUROFER position paper
determining the borderline between Chromium:10.5%to 30%
preparation/artides for steel and steel Nickel:Up to 38%
products(1).
Molybdenum:Up to 11%
In accordance with REACH and the CLP Carbon:less than 1.2%
Regulation (1272/2008/EC), only substances Iron:Balance
and preparations require a Safety Data Sheet
(SDS). While artides under REACH do not Other elements such as Manganese (Mn),
require a dassic SDS, REACH Article 32 Nitrogen (N), Niobium(Nb),Titanium (Ti), Copper
requires articles to be accompanied by (Cu) and Silicon (Si) may be present. For more
sufficient information to permit safe use and information on the chemical composition of
disposal. In order to comply with this standard stainless steels:see EN 10088-1:2014.
requirement, EUROFER members have
developed of this Safety Information Sheet
(SIS) that provides information on the safe Due to the natural origin of the material also some
use of the stainless steel and its potential elements that have not been intentionally added
impacts on both human health and may be present as impurities (Co, As, Sb). The
environment concentration of these elements in some cases
could accumulate up to more than 0.1%.
2.-ARTICLE DATA 2A.-Article physical and chemical properties:
2.1.-Article name and description: Physical state:solid
Colour.silver-grey
Acerinox stainless steel products in massive Odour:odourless
product forms: semi-finished products, plate, Density:7.7—8.3 g/cm3
sheet, strip, bar, tube, fittings, wire rod and Melting point:1,325 to 1,530°C
wire. Watersolubility:Insoluble
Stainless steel as defined in European Stainless steels are stable and non-reactive under
Standard EN 10088:1:2014 cover corrosion normal ambient atmospheric conditions, because
resisting, heat resisting, and creep resisting in solid form all alloying elements are firmly
steels bonded in the metallic matrix. Solid stainless steel
does not contain Chromium VI compounds. Only
when molten or during welding operations (I.e.
2.2:Article supplier details: heated to very high temperatures),fumes may be
produced.
ACERINOX S.A. In contact with strong acids, stainless steels may
Santiago de Compostela 100 release gaseous acid decomposition products(e.g.
28035 Madrid-SPAIN- hydrogen and oxides of nitrogen) and chromium
Telephone:+34 91 3985100 may be released in the form of Chromium III.
E-mail: _..,,....=cioncu.a,..,.,iox.com
Web: ovw.acerinox.com
ACERINOX SIS
ACERINOX Safety Information Sheet Q of�ue;05May2016
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In contact with strong oxidizers at high pH This SIS presents relevant information for
(e.g. alkaline cleaners at pH 10-14), very downstream users in order to secure a proper
small amounts of Chromium VI compounds use of the stainless steel articles supplied.
may form at ambient temperatures.
None of these substances are intended to be
released under normal or reasonably 4:SAFETY INFORMATION
foreseeable conditions of use. Exposure to
humans or the environment during normal or 4.1.-Description of Hazards
reasonably foreseeable conditions of use
including disposal is negligible. 4.1.1:Classificationand 1310-elution
All intentionally added alloying elements in
3.- GENERAL INFORMATION ON THE SAFE Stainless Steel with the exception of nickel
USE OF STAINLESS STEEL PRODUCTS are not classified as hazardous.Nickel is the
only substance of major importance with
All stainless steels contain a minimum of 10.5% regard to the hazard dassification of
chromium, which ensures the formation of a stainless steels in the solid form. In
protective, adherent nanometric, oxide film accordance with (EC) Regulations
covering the entire surface. Thus,the allowing 1272/2008 (CLP) and 790/2009 (ATP 1),
elements in stainless steel are firmly bonded in nickel is classified as a Carcinogen
its chemical matrix. Increasing the chromium Category 2, Specific Target Organ Toxicity
content beyond the minimum of 10.5%confers Repeated Exposure 1 (STOT RE1)and Skin
still greater corrosion resistance. Corrosion Sensitizer 1.
resistance may be further improved,and a wide
range of properties provided, by the addition of The exposure route for the nickel
other chemical elements (e.g. nickel and carcinogenic Category 2 classification is
molybdenum). Corrosion from stainless steel in inhalation. However Stainless Steel in solid
aggressive media can be avoided by use of the form cannot be inhaled, only when it is in
proper grade in accordance with relevant powder form. The risk of being exposed to
European or international standards. nickel in stainless steel can therefore also
only exist when the stainless steel is in
Stainless Steels are alloys. The alloying powder form. Nevertheless the European
elements in stainless steel are firmly bonded in Classification is based on Hazard rather
its chemical matrix. Due to this bonding and to than on Risk.Therefore it is the obligation of
the presence of a protective oxide film the the steel industry to provide proof that
release of any of the constituents is very low stainless steel is safe.
and negligible when the steel is used
appropriately. Even when steel is in powder form the
likelihood of being exposed to nickel is far
Stainless steels are generally considered non- less than the pure metal thanks to the
hazardous to human health or the environment alloying effect. In other words when nickel Is
(see paragraph 3.2)and regularly applied where in the form of stainless it doesn't necessarily
safety and hygiene is of utmost importance(e.g. become available to the organism which is
equipment in contact with drinking water, food inhaling the stainless powder. It is not bio-
contact materials,medical devices,etc.). available.
MOH
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This bio-availability can only be proven by doing Clinical studies did not reveal any risk of allergy
in vivo testing using test animals. There are two among individual already sensitised to nickel.
tests described in literature for in Vivo testing of Thus,frequent intermittent contact with stainless
stainless powder(2,3,4). steels of all types should not pose a problem to
downstream users or consumers(7).
As industry is encouraged to find alternative
ways to animal testing the non-ferrous metals 4.1.3.-Specific Target Organ Toxicity
industry in Europe is developing a testing
methodology based on Bio-elution. This In accordance with the CLP Regulation,stainless
methodology is an in vitro methodology thus steels are considered to be mixtures(8,9).This
preventing the necessity of in vivo testing.In Bio- means that stainless steels containing more than
elution body fluids like saliva, gastric, lung and 10% nickel should be classified as Specific
intestinal fluids are mimicked and the specific Target Organ Toxicity Repeated Exposure 1
release of constituents is tested. In these tests (STOT RE1)and stainless steels containing 1 -
the bio-accessibilityis being established. 10% nickel should be classified as STOT RE 2.
Stainless steels containing less than 1% nickel
The European Steel Industry together with the are not classified.
European Non-ferrous industry strongly believe
that bio-accessibility In vitro tests will become a However, a 28-day repeated inhalation study on
good and sustainable alternative to animal rats with stainless steel in the powder form (2)
testing and we believe that bio-accessibility data clearly indicates a lack of toxicity(i.e.no adverse
are a good predictor of bioavailability and toxicity effects were seen, even at the highest
for use in hazard assessment. concentration of stainless steel, which was 1.0
mg/L in the study), whereas the lowest nickel
4.1 2.-Sensitization dose (0.004 mg/L) resulted in dear signs of
toxicity in a 28-day nickel inhalation study(3,4).
No classification of stainless steel for STOT is
According to REACH (5), alloys that contain Ni proposed.
and that could come in frequent contact with skin,
may be tested according to European standard
EN1811 to determine the release rate of Ni. 4.1.4.-Carcinogenicity
Tests conducted in accordance with this standard
determined that stainless steels release nickel at In accordance with the CLP Regulation,stainless
levels significantly below the criteria set for steels are considered to be mixtures.This means
classification as a skin sensitizer.Thus,stainless that stainless steels containing more than 1%
steels in general are suitable for use as piercing nickel should be classified as Carcinogen
posts(where the maximum nickel release limits Category 2 when it is dassified as a simple
is 0.2 pg/cm2/week) and for those applications mixture. However, no carcinogenic effects
involving close and prolonged contact with the resulting from exposure to stainless steels have
skin(where the maximum nickel release limits is been reported, either In epidemiological studies
0.5 ug/cm2/week). or in tests with animals(7).Therefore, it can be
concluded that the weight of evidence supports
However,tests conducted in accordance with EN the non-carcinogenicity of stainless steel.
1811 (6)have shown that the resulphurised free-
machining stainless steels (containing 0.15 — In addition, IARC (International Agency for
0.30%sulphur)release nickel at levels close to, Research on Cancer) has concluded that
or above, the maximum nickel release limit 0.5 stainless steel implants are not classifiable as to
pg/cm2/week. Resuiphurised free-machining their carcinogenicity to humans (10). Several
stainless steels are, therefore, not suitable for stainless steel grades are specifically designed
use as piercing posts or for applications involving for use in human Implant parts(see ISO 5832).
prolonged contact with the skin (i.e. jewellery, Stainless steels containing less than 1% NI are
watch backs and watch straps,etc.). not classified.
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4.1.5.-Summary classification The process of welding should only be performed
by trained workers with the personal protective
According to CLP an alloy can be classified either on equipment in accordance with the laws of each
its constituentsdassification(simple mixture)or on Member State relating to safety.Guidance on the
the hazard properties the mixture if they have been welding of metals and alloys is provided on the
tested.Based on studies on the stainless steel alloy European Welding Association website(12).The
(7)the steel industry proposes the following guidance document will provide background
classification for stainless steel: information on health hazards posed by welding
processes and appropriate Risk Management
Measures.
No classification for most stainless steel grades.
There are no specific occupational exposure
For re-suiphurised grades(0.15—0.30%sulphur) limits for stainless steel. However, specific
Skin Sensitizer. occupational exposure limits have been
established for some constituent elements and
For a comparison between classification according to compounds. Users of this Safety Information
constituent and classification based on alloy testing, Sheet are strongly advised to refer to the
see Annex 1. Occupational Exposure Limits set by their EU
Member State for the substances in stainless
steel and where relevant,welding fumes.
4.2.-Specific process and exposure controls
4.3.-First Aid Measures
Dust and fume may be generated during processing
e.g. in welding, cutting and grinding. If airborne There are no specific First Aid Measures
concentrations of dust and fume are excessive,
inhalation over long periods may affect workers' developed for the stainless steel.. Medical
health,primarily of the lungs. Dust and fume quantity attention should be provided in case of an
and composition depend on specific practice. excessive inhalation of dust or a physical injury
Oxidized forms of the various alloying elements of to the skin or to the eyes.
stainless steel may be found in welding fumes.
In case of eye injury note that austenitic
Over long periods, inhalation of excessive airborne stainless steel particles are non-magnetic or
levels may have long term health effects, primarily only slightly magnetic and may not respond
affecting the lungs. Studies of workers exposed to to a magnet placed over the eye. In such
nickel powder,and dust and fumes generated in the cases seek hospital treatment.
production of nickel alloys and stainless steels have
not indicated a respiratory cancer hazard(7).
4.4.-Handling and Storage
Chromium in stainless steel is in the metallic state
(zero valence) and stainless steel does not contain There are no special measures for handling
hexavalent chromium. Welding and flame cutting stainless steels. Normal precautions should be
'fumes may contain hexavalent chromium taken to avoid physical injuries produced mainly
corn pounds. Studies have shown that some by sharp edges. Personal protective equipment
hexavalent chromium compounds can cause cancer. must be used e.g. special gloves and eye
However, epidemiological studies amongst welders protection.
indicate no extra increased risk of cancer when
welding stainless steels, compared with the slightly Stainless steels should be stored in manner that
increased risk when welding steels that do not prevents iron contamination. Avoid placing or
contain chromium. IARC has defined the welding storing stainless steel in uncoated iron or steel
process and welding fumes as a risk,irrespectively of racks and protect from iron emissions from
which metals that are involved(11). cutting/grinding operations.
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Care should be taken to avoid exposing fine 4.5.4:Toys
process dust (e.g. from grinding and blasting
operations)to high temperatures as it may present Safe use of stainless steel in toys is
a potential fire hazard. recognized in European Directive
2009/48/EC.
4.5.-Uses
Stainless steels are present in a wide variety of
activities. Main use areas indude industrial processes, 5.-ENVIRONMENTAL INFORMATION
architectural and building, house appliances and
kitchenware,catering and transportation.
There are no hazards to the environment from
stainless steel in the forms supplied.
4.5.1:Foal Contact Stainless steel is part of an integrated life cycle
and it is a material that is 100%recyclable.Thus,
Stainless steel has been in use for contact with food for surplus and scrap (waste) stainless steel is
many years and is present in various articles valuable and In demand for the production of
(kitchenware, bowls,and industrial kitchen appliances). prime new stainless steel. Recycling routes are
Depending on the application (knives, blades, forks, well-established, and recycling is therefore the
spoons,bowls),different grades are selected and have preferred disposal route.While disposal to landfill
been recognized as safe. The Council of Europe has is not harmful to the environment,it is a waste of
published new technical test guideline to ensure the resources and therefore to be avoided for the
suitability and safety of finished articles of metals and benefit of recycling.
alloys in food contact (13). The release of specific
constituents has to be below certain specific release
limits (SRL). Some national laws also give detailed
information on the choice of grades that should be
allowed for food contact.
4.5.2.-Medical devices and implants
In many cases stainless steel is the only material which
can be used for medical devices and/or implants.
Presently the Directive 90/385/EEC on Active
Implantable Medical Devices and Directive 93/42/EEC
on Medical Devices are being revised.
4.5.3.-Drinking water
The four Member States Common Approach (agreed
between Germany, France, the Netherlands and the
United IGngdom) describes a procedure by which a
material is approved. The list of "Metallic materials
suitable for drinking water under hygienic aspects"
indudes those metallic materials,for which the hygienic
suitability for drinking water has been demonstrated.
This includes stainless steel.
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6.-REFERENCES
1. EUROFER position paper determining the borderline between preparations and articles for steel and
steel products.28 October 2008.
http://www.eurofer.org/Issues%26Positions/REACH/REACH.itpl
2. SafePharm Laboratories(2008).Stainless steel powder(Grade 316L):Twenty-eight day repeated dose
exposure inhalation(nose only)toxicity study in the rat,SafePharm Laboratories:1-249.
3. WIL Research Laboratories,I.(2002).A 4-week range-finding Inhalation toxicity study of nickel metal in
albino rats,WIL Research Laboratories,Inc.:1-319.
4. Inhalation carcinogenicity study with nickel metal powder In Wistar rats.A.R Oiler et al.,Toxicology and
Applied Pharmacology 233(2008)262-275.
5. Regulation(EC)No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration,Evaluation,Authorisation and Restriction of Chemicals(REACH).
6. EN 1811:2011+AI:2015 Standard:Reference test method for release of nickel from all post assemblies
which are inserted into pierced parts of the human body and articles intended to come into direct and
prolonged contact with the skin(test for measuring Ni release in artificial sweat).
7. Review on toxicity of stainless steel,Finnish Institute of Occupational Health(FIOH),2010
http://www.ttl.fl/en/publications/Electronic_publications/Pages/default.aspx.
8. Regulation(EC)No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification,labelling and packaging of substances and mixtures.
9. Regulation(EC)No 790/2009 1st Adaptation to Technical Progress(ATP)to the CLP Regulation
10. IARC(1999).Surgical implants and other foreign bodies.Geneva,World Health Organization,IARC.
11. Manufacture,processing and use of stainless steel:A review of the health effects,EUROFER,1999
http://www.eurofer.orglindex.ph p/eng/News-Pu blicationslPublications.
12. http://uwuw.european-welding,org/wp-content/uploads/2012/01/Communication-statementsjuly_2010.pdf.
13. Metals and Alloys used In food contact materials and articles,EDQM,CoE,2013,1st Edition,
ISBN 978-92-871-7703-2,Specific chapter on Stainless Steels pp165,www.edqm.eu.
Information given in this data sheet may be subject to alterations without notice.Care has been taken to ensure that the contents
of this publication are accurate but Acerinox and its affiliated companies do not accept responsibility for errors or for information
which is found to be misleading.
Suggestions for or descriptions of the end use or application of products or methods of working are for information only and
Acerinox and its affiliated companies accept no liability in respect thereof.Before using products supplied or manufactured by the
company the customer should satisfy himself of their suitability.
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ANNEX 1
Table 1 gives classification proposal based on testing performed on stainless steel,and Table 2 gives
the classification according to constituents(in this case nickel).
Table 1-Classification proposal based on testing performed on stainless steel.
Skin Sensitizing Specific Target Carcinogenicity
Organ Toxicity
STOT
tarn ess No Classlfi :io:. No Classification No Classific abcn
steel
For re-sulphurised
grades only:Skin
Sensitizer 1
H317
•As this proposal Is based on weight of evidence on alloy testing it is not the CMR classification
according to mbdure rules in CLP.According to CLP,the carcinogenicity classification outlined in
Table 2 should apply.
Table 2-Classification based on constituents.
Skin Sensitizing SpecificTarget Carcinogenicity
Organ Toxicity
•
tain ess No Classification No Classification No Classification
steel
<1%Ni
Stainless Skin Sensitizer 1 STOT RE2 Carcinogen Category 2
steel H317 H373(Inhalation) H351(Inhalation)
1 -10%Ni
Stainless Skin Sensitizer 1 STOT RE1 Carcinogen Category 2
Steel H317 H372(Inhalation) H351 (Inhalation)
>10%Ni