Download Macrolex div reg 2021-02-24

LANXESS Deutschland GmbH / D-50569 Cologne, Germany
To whom it may concern
Non-use of various substances and conformities
February 24, 2021
Dear Madam or Sir,
We hereby confirm, that for the final production step of our Macrolex®
dyestuffs the following substances are not intentionally used and are not
known to be present except technically unavoidable ubiquitous traces:
1) Heavy Metals including their compounds for Macrolex grades except
Macrolex Fluorescent Red G and Fluorescent Yellow 10GN:
1a Cadmium and Cadmium compounds
1b Lead and Lead compounds
1c Mercury and Mercury compounds
1d Hexavalent chromium and its compounds
1e Arsenic and Arsenic compounds
1f Antimony
1g Cobalt, Nickel
2) Chlorinated restricted organic Compounds:
2a Polychlorinated Biphenyls (PCB)
2b Polychlorinated Terphenyles (PCT)
2c Polychlorinated Naphthalenes ( PCN )
2d Chlorinated paraffins (CP, SCCP)
2e Mirex ( Perchlordecone )
3) Restricted brominated organic Compounds, e.g.:
3a Polybrominated biphenyls ( PBB )
3b Polybrominated diphenylethers ( PBDE, including Deca-BDE )
3c Tetrabromobisphenol-A-bis-(2,3-dibromopropylether )
3d HBCD
4) Organic tin Compounds (di- or tri-), e.g.:
4a Tributyl tin compounds
4b Triphenyl tin compounds
4c Di-µ-oxo-di-n-butylstanniohydroxyborane (DBB) 75113-37-0
5) Asbestos
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LANXESS Deutschland GmbH
Dr. Holger Schmidt
PTSE-HSEQ-GRA-GPS
K10 R. 1015
D-51369 Leverkusen
Phone +49 221 8885 5112
Fax +49 214 30 959 72909
mailto:[email protected]
www.lanxess.com
Executive Board:
Matthias Zachert
(Chairman)
Dr. Anno Borkowski
Dr. Stephanie Coßmann
Dr. Hubert Fink
Michael Pontzen
Chairman of the Supervisory
Board:
Dr. Matthias L. Wolfgruber
Registered Office: Cologne
Local Court Cologne
HRB 52600
VAT ID no. DE 814 000 384
Dr. Holger Schmidt
6) Palm oil
7) Formaldehyde, Formamide
February 24, 2021
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8) Ozone Depleting Substances (ODS)
9) PAH’s (Polycyclic aromatic hydrocarbons)
10) Latex
11) PVC, PVDC
12) Phthalates as Softener, e.g.:
DEHP CAS 117-81-7, DIBP CAS 84-69-5, DIDP CAS 26761-40-0, DINP
CAS 28553-12-0, DBP CAS 84-74-2, DNOP CAS 117-84-0, BBP
85-68-7, DNHP 84-75-3, DIOP 27554-26-3 etc.
13) Perfluorinated alkylated substances and derivatives, e.g.:
PFOA, PFOS,PFAS
14) REACH Substances of Very High Concern (SVHC) above a threshold
of 1000 ppm as listed here:
http://echa.europa.eu/web/guest/candidate-list-table
15) Radioactive Substances
16) Conflict Minerals such as gold, tin, tungsten, tantalum including their
compounds
17) Miscellaneous:
Pesticides, Biocides, Preservatives, Paraben, Flame Retardants, Nitrosamines,
Dimethylfumarate, Sulphur hexafluoride, Bisphenols (e.g. -A, AF, -AP, -B, -C, F, -M, -S), HCB, BHT, Fragrances, Allergens, NOGE, BFDGE, BADGE,
Endocrine disrupting compounds (EDC), Antioxidants, Antistatics, UVstabilizers, Raw materials of human or animal origin, Substances of GMO
origin, Substances with a risk of BSE/TSE, Formaldehyde, Tributylamine,
APEO, Ag, Ba, B, Be, Sn and their compounds, Silicones, Siloxanes,
Colophony, Fluorine, Bromine,
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Quaternary ammonium compounds (QATS), MOSH, MOAH, POSH,
Benzene, Toluene, Xylene, Styrene, Ethylbenzene, Monochlorbenzene,
Acetyl tributyl citrate, Bis(2-ethylhexyl)adipate, Epoxidized soy bean oil,
Glycerol mono oleate and – stearate, Nitrites, Nitrates, Melamine, Volatile
Organic Compounds (VOC), Butylhydroxytoluene (BHT),
Alkylphenols,Alkylphenolethoxilates, Nonylphenols, Dioxines, Sulfites,
Epoxides, Glycol ethers, DTDMAC, Phthalic acids, Aflatoxine, Aluminium,
Tris(nonylphenyl) phosphite (TNPP), Phosphorous compounds, Carbon
black, Dual use substances, Sudan Red, Microplastic, Benzidine, Aniline,
Dr. Holger Schmidt
February 24, 2021
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Furthermore substances listed in the following regulations:
Directive 2011/65/EC (RoHS) and all amendments until today
Directive 94/62/EC and CONEG
POP Convention EU 850/2004
GADSL:
With regard to GADSL there is to declare that
Macrolex Red EG contains traces of Hexachlorobenzene.
Macrolex Red Violet R, Yellow G, Yellow E2R, Orange 3G , Red E2G and
Red EG contain traces of Phenol.
Halogens:
For the production of our a.m. Macrolex dyestuffs no molecules containing
Bromine or Chlorine are intentionally used for the final production step,
neither the halogens Fluorine, Iodine and Astatine, which are not expected
to be present above technically unavoidable ubiquitous trace level except
Macrolex Red EG and Fluorescent Yellow 10GN, in which organic
bound chlorine is part of the molecular structure.
VOC and Swiss VOC:
We can confirm, that no substances are intentionally added to our colorants in
such quantities, that there could be found measurable VOC as defined in
1999/13/EC and for Switzerland.
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Use of Macrolex® grades for consumer sensitive applications
Dr. Holger Schmidt
February 24, 2021
We further consider the named
Macrolex®
grades excepting Macrolex
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- Black 2B,
- Fluorescent Red 4B,
- Fluorescent Red G,
- Fluorescent Yellow 10GN,
- Yellow 3G
as being compliant to the below following referred regulations concerning
various sensitive consumer applications.
FDA:
For products mentioned below we have opinion letters of Keller and Heckman. Levels and
conditions of use are related to the colorant independent from the physical shape as
powder, Feingut (FG) or granulate (Gran). Descriptions of the conditions of use can be
found under 21 CFR § 176.170 (c), Table 2. Contact with aqueous, acidic, low alcohol
content (up to 15 % ethanol) and dry foods.
PET and PETG [with up to 5% 1,4-Cyclohexanedimethanol]:
Grade
Max level of use Conditions of use
MACROLEX YELLOW G
0,20%
C-G
MACROLEX YELLOW 6G
0,40%
C–G
MACROLEX YELLOW E2R
0,20%
C-G
MACROLEX ORANGE R
0,20%
C-G
MACROLEX ORANGE 3G
0,20%
C-G
MACROLEX RED 5B
0,20%
C-G
MACROLEX RED E2G
0,20%
C-G
MACROLEX RED EG
0,60%
A-H
MACROLEX RED B
0,40%
C-G
MACROLEX RED A
0,10%
C-G
MACROLEX RED VIOLET R
0,60%
C-G
MACROLEX VIOLET 3R
0,20%
C-G
MACROLEX VIOLET B
0,20%
D-G
MACROLEX BLUE 3R
0,60%
A-H
MACROLEX BLUE RR
0,20%
C-G
MACROLEX GREEN G
0,20%
D-G
MACROLEX GREEN 5B
0,60%
C-G
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PS:
Dr. Holger Schmidt
Grade
Max level of use Conditions of use
MACROLEX ORANGE R
0,20%
D-G
MACROLEX RED EG
0,20%
D-G
MACROLEX RED VIOLET R
0,20%
D-G
MACROLEX BLUE 3R
0,20%
D-G
MACROLEX GREEN 5B
0,20%
D-G
February 24, 2021
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Tritan:
Grade
Max level of use
MACROLEX YELLOW 6G
0,20%
MACROLEX ORANGE R
0,20%
MACROLEX RED E2G
0,20%
MACROLEX RED VIOLET R
0,20%
MACROLEX VIOLET B
0,20%
MACROLEX BLUE 3R
0,20%
MACROLEX BLUE RR
0,20%
MACROLEX GREEN 5B
0,20%
Conditions of use: In repeated use articles in contact with aqueous, acidic, and low-alcoholic
(up to 15% alcohol) and dry foods at temperatures up to 100ºC, in contact with high
alcoholic foods at temperatures up to 40ºC and in contact with fatty foods for short duration
(i.e., less than 8 hours) at temperatures up to 40ºC.
California Proposition 65:
Please refer to the current US SDS for information regarding this regulation.
EU 1935/2004
The requirements and specifications as far as they affect the products stated above, are
fulfilled.
EU 10/2011 and amendments until today:
Colorants are in principle exempted. Regarding NIAS please be informed, that for the grades
Blue 3R, Blue RR, Green 5B, Green G, Red 5B, Violet 3R, Violet B and Violet 3B the migration
limit of primary aromatic amines into food of 0,01mg/kg needs to be monitored,
for the grades Red Violet R, Yellow G, Yellow E2R, Orange 3G , Red E2G and Red EG the
migration limit of phenol into food of 3mg/kg needs to be monitored.
For quantitative figures about the product purity please see in the product quality specifications.
A polymer additive based on positive listed monomers is used.
EU 2023/2006:
Colorants as starting materials are exempted from concerning rules.
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BfR and Resolution AP (89) 1:
Based on unregular spot analysis we assume a.m. Macrolex as being in line with the
German BfR recommendation IX and Resolution AP (89) 1 regarding purity requirements
for colorants used in consumer goods. Extraction limits need to be monitored at the final
article.
Dr. Holger Schmidt
February 24, 2021
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2009/48/EC – Safety of Toys
No forbidden or restricted chemicals as listed in chapter III “chemical safety” are known to
be present in relevant quantities.
Netherlands
Warenwetregeling verpakkingen en gebruiksartikelen , 2013 0407 NL – 20130822 : Our
grades are compliant regarding the purity criteria. The heavy metal restrictions of the final
product need to be monitored.
Spain, Real Decreto 847/2011 of June 17, 2011
Based on unregular spot analysis we assume a.m. Macrolex as being in line with Real
Decreto 847/2011 regarding purity requirements for colorants used in consumer goods.
Extraction limits need to be monitored at the final article.
Italy, Decreto Ministeriale of March 21, 1973 and subsequent amendments
Based on unregular spot analysis we assume a.m. Macrolex as being in line with Decreto
Ministeriale of March 21, 1973 regarding purity requirements for colorants used in
consumer goods. Extraction limits need to be monitored at the final article.
Belgium
According toour best state of knowledge based on spot analysis we assume above named
products to be in line with criteria as outlined in Koninklijk Besluit dated 11.5.1992;
Warenwetgeving (1), aanvulling nr. 18 - September 1992 as far as applicable to colorants.
United Kingdom
Plastics for food contact applications, a code of practice for safety in use: BPF in connection
with BIBRA, revised edition 1986. We assume, that local organizations have checked compliance
to these national requirements.
French Circular 176
Based on unregular spot analysis we assume a.m. Macrolex as being in line with French Circular
176 regarding purity requirements for colorants used in consumer goods. Extraction limits need
to be monitored at the final article.
China GB 9685:2016 and amendments until today:
Yellow G
Yellow 6G
Yellow E2R
PET 0,2
PET 0,2
PET 0,2, PS, AS, ABS, PA, PC, PVC
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Orange R
Orange 3G
Red 5B
Red E2G
Red EG
Red B
Red A
Red Violet R
Violet 3R
Violet B
Violet 3B
Blue 3R
Blue RR
Green G
Green 5B
ABS 0,13, PC 0,04, PPE
PET 0,2
PET 0,2, ABS 0,05, PC 0,05, PBT, PPE, PEI
PET 0,2, PEI 0,15
PET, PE, PP, PS, AS, ABS, PA, PC, PVC, PVDC, UP, PPE 0,2, PEI 0,2
PET 0,1, PS, AS, ABS, PC, PVC
ABS 0,13, PC 0,04, PPE
PET 0,2, PS 0,2, ABS 0,2, PPE 0,01, PS 0,2
PET 0,2, PVC 0,02, PC 0,2
PET, PS, AS, ABS, PA, PC, PVC, PVDC, UP, PPE, PEI
PET, PS, AS, ABS, PA, PC, PVC, each 0,2
PET 0,2
PET, PS, AS, ABS, PA, PC,
PC 0,2
PET, PS, AS, ABS, PA, PC, PVC, each 0,2, PPE
Dr. Holger Schmidt
February 24, 2021
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figures = max. dosage in %, if no figure added: dosage as necessary.
Polymer abbreviations according to ISO 1043
Further additional restrictions of use my apply as outlined in GB 9685:2016.
Mercosur:
General quality requirements including metal limit values outlined in GMC Res. 15/10 are
regarded as fulfilled. Not all are analysed, because the substances which are not
intentionally used, are not expected to be present above traces.
Based on unregular spot analysis we assume a.m. Macrolex as being in line with Mercosur
requirements regarding purity requirements for colorants used in consumer goods.
Extraction limits need to be monitored at the final article.
Swiss Ordinance SR 817.023.21 The following products are listed:
Product
Restriction
MACROLEX ORANGE 3G
B
MACROLEX RED EG
B
MACROLEX RED B
B
MACROLEX VIOLET 3R
B
MACROLEX VIOLET B
A
MACROLEX VIOLET 3B
B
MACROLEX GREEN 5B
B
B means migration below detection level - A means without restriction
JAPAN:
For our JHOSPA listings please see in our brochure.
Medical Applications:
In the US there are listed Macrolex Green 5B:
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and Violet B:
Dr. Holger Schmidt
February 24, 2021
The other grades have to be tested by the producer of the final good.
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Kosher, Halal:
We have no certificates but we assume the preconditions as fulfilled.
Named products are of synthetic origin.
For further details please see the MSDS and Technical Information of the Macrolex®
dyestuffs or contact your local LANXESS Affiliate.
Additional information may be found here:
www.lanxess.com
Sincerely
LANXESS Deutschland GmbH
Dr. Holger Schmidt
PTSE-HSEQ Regulatory Affairs, REACH & Product Stewardship
This information and our technical advice - whether verbal, in writing or by way of trials - are given in
good faith but without warranty, and this also applies where proprietary rights of third parties are
involved. Our advice does not release you from the obligation to check its validity and to test our
products as to their suitability for the intended processes and uses. The application, use and processing
of our products and the products manufactured by you on the basis of our technical advice are beyond
our control and, therefore, entirely your own responsibility. Statements regarding consistency are valid.
Our products are sold in accordance with the current version of our General Conditions of Sale and
Delivery.
In the United States of America the LANXESS business is conducted by LANXESS Corporation, Pittsburgh,
PA. Customers in the USA are kindly asked to address their requests directly to this legal entity.
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