Guia de Colorantes

Colorants portfolio for
sensitive applications
Pigments for plastics
Table of contents
Pigments for plastics 3
Table of contents
Introduction 4 Legislation on toys 45
Colorants portfolio for Other sensitive applications 46

sensitive applications 6
Disclaimer 47
Colorants for
food contact materials 8
Appendix: Definitions
and abbreviations 48
Colorants for toys 28
Legislation for food

contact materials 39
Introduction
Introduction
This document gives an overview of BASF selected colorants portfolio for plastics listed
by national regulations and additionally provides a summary of the key regulations ruling
colorants for plastics going into food contact materials and toys. It is meant as a general
introduction for everyone who wants to get a baseline understanding of the regulatory
framework for food contact material and toys. If further information is required, please
contact pigments-safety@basf.com.
Where general comments are provided, the original text of the law or standard has to be
consulted to avoid misunderstandings and incorrect interpretations.
All information in this document has been compiled with great care and reflects BASF
best knowledge at the date of issue (September 2017). Due to continuous evolution
of the subject, information may rapidly change and therefore this document can only
be considered as a snapshot of the current situation as at the date of publication
(September 2017). To ensure the full updated compliance status of a given product to
the newest legislation requirements or technology changes, we strongly recommend
that our customers systematically check this status with their BASF representative or
contact BASF via pigments-safety@basf.com.
6 Colorants portfolio for sensitive applications
Colorants portfolio for sensitive applications
Colorants portfolio for

sensitive applications
Product scoping As a result of all those precautionary measures, BASF Purity limits for BASF products in color- Extractable impurity in the colorant Limit [ppm]
can now, for all products listed in this colorants port ants portfolio for sensitive applications Aluminum (Al) 1,000
This document lists the BASF portfolio of colorants for folio for sensitive applications, deliver Food Contact
Antimony (Sb) 45
plastics and fibers that will be actively supported for Certificates (FCC) moving forward. FCC provided by For products that have been selected in BASF
use in sensitive applications such as food packaging BASF for plastic food contact materials is the official colorants portfolio for sensitive applications, “spot Arsenic (As) 3
and toys. document that covers the EU Declaration of Compliance testing” program with an adapted testing scope Barium (Ba) 100
(DoC) legal requirements as well as the compliance and frequencies are defined in order to regularly
Detailed compliance status of BASF organic, inorganic requirements of other regional jurisdictions as applicable. check that products are manufactured in line with Boron (B) 1,000
and effect pigments as well as polymer soluble colorants target purity levels. If required, spot testing can be Cadmium (Cd) 1
and pigments preparations is provided in the Appendix BASF colorants portfolio for sensitive applications is extended for systematic batch to batch analysis by
Chromium (Cr III + Cr VI) 1
table, listed for each product per national regulations. regularly reviewed in line with evolving regulatory requi- setting up an internal specification ensuring strict
rements, new developments in product technology and monitoring of target purity profile. Typical purity limits Cobalt (Co) 10
new findings in legal environment or product toxicology. as defined by BASF for colorants portfolio for sensitive Copper (Cu) 600
Definition and revisions applications are detailed below (BASF Purity Limits):
Lead (Pb) 2
In order to ensure that the regulatory requirements are
BASF colorants for plastics portfolio screened for continuously met, the BASF Food Contact Certificates Manganese (Mn) 800
sensitive applications have been initially assessed for products in our colorants portfolio for food contact Mercury (Hg) 5
through specific criteria such as product fingerprint applications in plastics are updated on a 18 months
Nickel (Ni) 50
including purity profile, as well as manufacturing set-up basis, in order to cover the periodic updates of the
including consideration of cross-contamination risk. Plastics Regulation (EU) No. 10/2011, or earlier in case Selenium (Se) 25
of relevant regulatory changes. Strontium (Sr) 4,500
Also, when necessary, product processing behavior
in plastics was assessed and when needed, a product The BASF Food Contact Certificates for colorants Tin (Sn) 15,000
would have to undergo a risk assessment under portfolio for food contact applications in Plastics are Zinc (Zn) 1,000
standard or specific conditions of use. valid for 18 months.
Iron (Fe) 4,500
For those products, the Management of Change Even though it is the intention of BASF to sustain as Lithium (Li) 500
process at BASF systematically aims at retaining much as possible the compliance scope and depth of Primary aromatic amines (PAA) 500
existing compliance status for products affected the selective colorants portfolio for sensitive applications,
Benzidine, beta-naphthylamine, 4-aminobiphenyl 10
by modifications such as raw materials changes no guarantee can be given that all products will remain
or manufacturing process modifications. compliant under all circumstances, e.g., future evolu- Polychlorinated biphenyls (PCB) 25
tions of the regulatory environment. In such cases that
Table 1: BASF purity limits
shall remain exceptional, BASF will strive to provide
updated information to customers with pre-notice time.
These purity limits make it possible to meet the require
ments of most of the targeted end use applications,
e.g., food contact packaging and toys applications.
Colorants for food contact materials
Colorants for
food contact materials
Status as of September 2017
This portfolio is regularly reviewed according to business needs and regulatory

requirements. For any updates please contact the pigments-safety@basf.com mailbox.
The overview of products’ compliance status in the tables on the next pages should
be used as a general guide only. In any case, it does not replace the product detailed
information in the Food Contact Certificates.
For more detailed information on specific country requirements and conditions of use,
please refer to the relevant Food Contact Certificates, which are available via
pigments-safety@basf.com upon request.
10 Colorants for food contact materials
Colorants for
Status: September 2017 1 Compliant 5 Compliant with use restrictions* 0 Not compliant
Food Contact Regulations

European Union USA Japan Australia China Mercosur
Product Old product name C.I. name
France Spain Italy GMC
1935/2004/ EC Regulation Germany GB4806.1-2016
AP(89)1 Brochure Real Decreto Decreto FDA, 21CFR JHOSPA JHPA AS 2070-1999 GB9685-2016 Resolución
EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Cinquasia® Magenta K 4535 Cinquasia® Magenta RT-235-D PR 202 1 1 1 5 5 1 1 5 5 1 1 5 1 1
Cinquasia® Magenta K 4535 FP Cromophtal® Magenta P PR 202 1 1 1 5 5 1 1 5 5 1 1 5 1 1
Cinquasia® Pink K 4410 Cromophtal® Pink 2000 PR 122 1 1 1 5 1 1 1 5 5 1 1 5 1 -
Cinquasia Pink K 4430 FP

®
Cromophtal Pink PT
®
PR 122 1 1 1 5 1 1 1 5 5 1 1 5 1 1
Cinquasia Red K 4104

®
Cromophtal Red 2020
®
PV 19 1 1 1 5 1 1 1 5 5 1 1 5 1 1

®
Cromophtal Red TBR
®
PV 19 1 0 1 5 0 0 0 5 0 5 1 0 - -
Cinquasia® Red K 4330 Cinquasia® Red B RT-195-D - 1 1 1 5 0 1 1 5 5 0 1 5 1 1
Cinquasia® Violet K 5350 Cinquasia® Violet R RT-891-D PV 19 1 5 1 5 0 5 5 5 5 0 1 5 1 1
Cinquasia Violet K 5350 FP

®
Cromophtal Violet RP
®
PV 19 1 5 1 5 0 5 5 5 5 0 1 5 1 1
Cromophtal Brown K 3001

®
Cromophtal Brown 5R
®
PBr 23 1 1 1 5 1 1 1 0 5 5 1 5 1 -
Cromophtal Orange K 2960

®
Cromophtal Orange GP
®
PO 64 1 1 1 5 1 1 1 5 5 0 1 5 1 1
Cromophtal® Red K 3830 Cromophtal® Red G PR 220 1 1 1 5 5 1 1 5 5 5 1 5 1 1
Cromophtal® Red K 3890 Cromophtal® Red BRN PR 144 1 1 1 5 5 1 1 0 5 5 1 5 1 1
Cromophtal Red K 3890 FP

®
Cromophtal Red BRNP
®
PR 144 1 1 1 5 5 1 1 0 5 5 1 5 1 1
Cromophtal Red K 3900

®
Cromophtal Red BN
®
PR 214 1 1 1 5 5 1 1 0 5 5 1 5 1 1

®
Cromophtal Red BNFP
®
PR 214 1 1 1 5 5 1 1 0 5 5 1 5 1 1
Cromophtal® Red K 4035 Cromophtal® Red 2B PR 221 1 1 1 5 1 1 1 0 5 5 1 5 1 -
Cromophtal® Scarlet K 3540 Cromophtal® Scarlet RN PR 166 1 1 1 5 5 1 1 0 5 5 1 5 1 1
Cromophtal Violet K 5700

®
Cromophtal Violet B
®
PV 37 1 1 1 5 1 1 1 0 5 5 1 5 1 1
Cromophtal Yellow 2GF

®
- PY 155 1 1 1 5 5 1 1 0 0 5 1 0 - -
Cromophtal Yellow K 0990

®
Cromophtal Yellow 8GN
®
PY 128 1 1 1 5 1 1 1 0 5 5 1 5 1 -
Cromophtal® Yellow K 0990 FP Cromophtal® Yellow 8GNP PY 128 1 1 1 5 1 1 1 0 5 5 1 5 1 -
Cromophtal® Yellow K 1210 Cromophtal® Yellow 3G PY 93 1 1 1 5 5 1 1 5 5 5 1 5 1 1
Cromophtal Yellow K 1210 FP

®
Cromophtal Yellow 3GNP
®
PY 93 1 1 1 5 5 1 1 5 5 5 1 5 1 1

®
Cromophtal Yellow 4GV
®
PY 215 1 5 1 5 0 5 5 5 5 0 1 0 - -

®
Cromophtal Yellow 2GO
®
PY 180 1 1 1 5 1 1 1 5 5 0 1 5 1 1
Cromophtal® Yellow K 1500 Cromophtal® Yellow GR PY 95 1 1 1 5 1 1 1 5 5 5 1 5 1 1
Cromophtal® Yellow K 1500 FP Cromophtal® Yellow GRP PY 95 1 1 1 5 1 1 1 5 5 5 1 5 1 1
Eupolen PE Blue 69-1501

®
- PB 15:1 5 5 1 5 0 5 5 5 0 0 5 0 - 5

®
- PB 15:1 1 5 1 1 5 5 5 5 0 1 1 5 1 1

®
- PB 15:1 1 5 1 1 5 5 5 5 0 1 1 5 1 1
* For more information please contact pigments-safety@basf.com

Colorants for

EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Eupolen® PE Blue 69-2005 - PB 15:1 1 5 1 1 5 5 5 5 0 1 1 5 1 1

®
- PB 15:3 1 5 1 1 5 5 5 5 0 1 1 5 1 1

®
- PB 15:4 1 5 1 1 0 5 5 5 0 0 1 0 - 1
Eupolen PE Brown 29-1505

®
- PR 101 1 5 1 1 5 5 5 5 0 1 1 5 1 1
Eupolen® PE Green 87-3001 - PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5
Eupolen® PE Green 87-3004 - PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5
Eupolen PE Green 87-3005

®
- PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5

®
- PG 7 5 5 1 5 5 5 5 5 0 0 5 5 1 5

®
- PG 36 5 5 1 5 5 5 5 5 0 0 5 5 1 5
Eupolen® PE Red 39-1101 - PR 178 5 1 1 5 1 1 1 5 0 0 1 5 1 1
Eupolen® PE Red 47-9001 - PR 122 1 1 1 5 1 1 1 5 0 1 1 5 1 1
Eupolen PE Yellow 09-6101

®
- PY 138 5 1 1 5 5 5 5 5 0 5 5 5 1 -

®
- PY 185 5 1 1 1 0 1 1 0 0 0 1 0 - -

®
- PY 215 1 5 1 5 0 5 5 5 0 0 1 0 - -
Eupolen® PE Yellow 17-6001 - PY 191:1 1 5 1 5 5 5 5 5 0 0 1 5 1 1
Eupolen® PE Yellow 17-6004 - PY 191:1 1 5 1 5 5 5 5 5 0 0 1 5 1 1

®
®
PY 183 1 1 1 5 1 1 1 5 0 0 1 5 1 1

®
- PY 139 5 1 1 1 0 1 1 0 0 0 1 0 - 1

®
- PY 139 5 1 1 1 0 1 1 0 0 0 1 0 - 1
Eupolen® PE Yellow 18-4105 - PY 139 5 1 1 1 0 1 1 0 0 0 1 0 - 1
Eupolen® PE Yellow 20-8501 - PY 110 1 5 1 5 5 5 5 5 0 0 1 5 1 1
Firemist Blue 9G630L

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Firemist Gold 9G230L

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Firemist Green 9G830L

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Firemist® Pearl 9G130L - - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Firemist® Red 9G430L - - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Firemist Turquoise 9G730L

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Firemist Violet 9G530L

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Glacier Crystal White EH 1030

®
- - 1 1 1 1 0 1 1 5 0 0 1 0 - -

Colorants for

EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Glacier® Frost White 9S130D - - 1 1 1 1 0 1 1 5 0 0 1 0 - 1
Glacier® Silk White EH 2012 (9S130V) - - 1 1 1 1 0 1 1 5 0 0 1 0 - -
Glacier® Sparkle White EH 1060 - - 1 1 1 1 0 1 1 5 0 0 1 0 - -
Heliogen Blue K 6850

®
- PB 15 1 5 1 1 5 5 5 5 5 1 1 5 1 1

®
- PB 15 1 5 1 1 0 5 5 0 5 0 1 0 - -

®
- PB 15:1 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Heliogen® Blue K 6903 - PB 15:1 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Heliogen® Blue K 6907 - PB 15:1 1 5 1 1 5 5 5 5 5 1 1 5 1 1

®
Heliogen Blue K 6911 D
®
PB 15:1 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Heliogen Blue K 6912 FP

®
- PB 15:1 1 5 1 1 5 5 5 5 5 1 1 5 1 -

®
- PB 15:1 1 5 1 1 0 5 5 0 5 0 1 0 - -
Heliogen® Blue K 7090 - PB 15:3 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Heliogen® Blue K 7090 FP - PB 15:3 1 5 1 1 5 5 5 5 0 1 1 5 1 1

®
Cromophtal Blue 4GNP.
®
PB 15:3 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Heliogen Blue K 7104 LW

®
- PB 15:4 1 5 1 1 0 5 5 5 5 0 1 0 - 1
Heliogen Green K 8683

®
- PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5
Heliogen® Green K 8730 - PG 7 5 5 1 5 5 5 5 5 5 5 5 5 1 5
Heliogen® Green K 8730 FP - PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5
Heliogen Green K 8730 Z

®
- PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5
Heliogen Green K 8740

®
Heliogen Green K 8740 LW
®
PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5
Heliogen Green K 9360 FK

®
- PG 36 5 5 1 5 0 5 5 0 5 0 5 5 1 -
Irgalite® Red K 4060 FP Irgalite® Red 2BSP PR 48:3 5 1 1 5 0 1 1 0 0 0 1 0 - 1
Irgalite® Red K 4170 FP Irgalite® Red 2BP PR 48:2 1 1 1 5 1 1 1 0 0 1 1 5 1 1
Irgalite Rubine K 4270 FP

®
Irgalite Rubine 4BP
®
PR 57:1 1 1 1 5 1 1 1 0 5 1 1 0 - 1
Irgalite Scarlet K 4165

®
- PR 48:3 5 1 1 5 0 1 1 0 0 0 1 0 - 1
Irgazin Flame Red K 3800

®
Cromophtal DPP Flame Red FP
®
PR 272 1 1 1 1 5 1 1 0 5 0 1 5 1 1
Irgazin® Orange K 2890 Cromophtal® Orange 2G PO 61 1 1 1 5 1 1 1 0 5 5 1 0 - 1
Irgazin® Orange K 2910 Cromophtal® DPP Orange TRP PO 71 1 1 1 1 5 1 1 0 5 0 1 0 - 1
Irgazin Red K 3840

®
Cromophtal Red 2030
®
PR 254 1 1 1 1 1 1 1 5 5 5 1 5 1 1
Irgazin Red K 3840 LW

®
Cromophtal Red 2028
®
PR 254 1 1 1 1 5 1 1 5 5 0 1 5 1 1
Irgazin Red K 3840 SQ

®
Cromophtal Red 1030-P
®
PR 254 1 1 1 1 1 1 1 5 5 5 1 5 1 1

Colorants for

EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Irgazin® Red K 3842 Cromophtal® DPP Red BP PR 254 1 1 1 1 1 1 1 5 5 5 1 5 1 1
Irgazin® Red K 3845 Irgazin® DPP Red BO PR 254 1 1 1 1 1 1 1 5 5 5 1 5 1 1
Irgazin® Red K 3845 LW Cromophtal® DPP Red BOC PR 254 1 5 1 1 5 5 5 0 5 5 1 5 1 1
Irgazin Rubine K 4080

®
Cromophtal Rubine TR
®
- 1 1 1 1 0 1 1 5 5 0 1 0 - -

®
Irgazin Rubine L 4025
®
PR 264 1 1 1 1 5 1 1 0 0 0 1 5 1 -
Irgazin Yellow K 2060

®
- PY 110 1 1 1 5 5 1 1 5 0 5 1 5 1 1
Irgazin® Yellow K 2060 FP Cromophtal® Yellow 3RLP PY 110 1 1 1 5 5 1 1 5 5 5 1 5 1 1
Irgazin® Yellow K 2060 SQ - PY 110 1 1 1 5 5 1 1 5 0 5 1 5 1 1

®
Cromophtal Yellow 2RLTS
®
PY 110 1 1 1 5 5 1 1 5 5 5 1 1 1 1

®
Cromophtal Yellow 2RLP
®
PY 110 1 1 1 5 5 1 1 5 5 5 1 5 1 -
Lumina Aqua Blue 9A30D

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Lumina® Brass 9232D - - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Lumina® Gold 9Y30D - - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Lumina Green 9G30D

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Lumina Red 9R30D

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Lumina Red Blue 9B30D

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Lumina® Royal Aqua Blue 9780H - - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Lumina® Royal Blue 9680H - - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Lumina Royal Copper 9390H

®
- - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Lumina Royal Indigo 9580H

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Lumina Royal Magenta EH 5001

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Lumina® Turquoise 9T30D - - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Magnapearl® 1000 - - 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Magnapearl 1000 DF-70

®
- - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Magnapearl 1100
®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Magnapearl 1110
®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Magnapearl® 2000 - - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Magnapearl® 2000 DF-70 - - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Magnapearl 2100
®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Magnapearl 2110
®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 1

®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 1

Colorants for

EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Magnapearl® 2300 - - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Magnapearl® 2300 DF-70 - - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Magnapearl® 3000 - - 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Magnapearl 3100
®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -

®
- - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Magnapearl 4000
®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Magnapearl® 4000 DF-70 - - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Magnapearl® 5000 - - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Magnapearl 8000
®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin Aztec Gold 9363 C

®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin Brilliant Gold 9212 G

®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin® Copper 9340 A - - 1 5 1 1 1 5 5 5 5 1 1 5 1 -
Mearlin® Inca Gold 9222 G - - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin Majestic Gold 9222 X

®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin Majestic Gold 9222 X DF-70

®
- - 1 5 1 1 5 5 5 5 0 1 1 5 1 1
Mearlin Mayan Gold 9233 X

®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin® Micro Bronze 9250M - - 1 5 1 1 5 5 5 1 0 1 1 5 1 -
Mearlin® Satin White 9130 F - - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin Satin White 9130 F DF-70

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Mearlin Sparkle Blue 9620 J

®
- - 1 1 1 1 1 1 1 1 5 1 1 5 1 -
Mearlin Sparkle Brass 9222 J

®
- - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Mearlin® Sparkle Bronze 9250 J - - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Mearlin® Sparkle Copper 9350 J - - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Mearlin Sparkle Gold 9212 P

®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin Sparkle Gold 9220 J

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin Sparkle Green 9820 J

®
- - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Mearlin® Sparkle Orange 9320 J - - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin® Sparkle Red 9420 J - - 1 1 1 1 1 1 1 5 0 1 1 5 1 -
Mearlin Sparkle Russet 9450 J

®
- - 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Mearlin Sparkle Violet 9520 J

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin Super Blue 9630 Z

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -

Colorants for

EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Mearlin® Super Blue-Russet 9650 Z - - 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Mearlin® Super Brass 9232 Z - - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin® Super Bronze 9250 Z - - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin Super Copper 9350 Z

®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin Super Gold 9230 Z

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 1
Mearlin Super Green 9830 Z

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin® Super Orange 9330 Z - - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin® Super Red 9430 Z - - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin Super Russet 9450 Z

®
- - 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Mearlin Super Sparkle 9110 S

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin Super Violet 9530 Z

®
- - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Mearlin® Super White 9020 C - - 1 1 1 1 1 1 1 5 5 1 1 5 1 -
Meteor® Yellow 9379 FF FK - - 1 1 1 1 1 1 1 5 0 0 1 5 1 -
Microlen Black 0068 MCN

®
- PBk 7 1 5 1 1 5 5 5 0 0 0 1 5 1 -
Microlen Blue 6907 MCN

®
- PB 15:1 1 5 1 1 5 5 5 5 0 1 1 5 1 1

®
- PB 15:1 1 5 1 1 5 5 5 5 0 1 1 5 1 -
Microlen® Blue 6916 MCN - PB 15:1 1 5 1 1 0 5 5 0 0 0 1 0 - -
Microlen® Blue 7090 MCN - PB 15:3 1 5 1 1 5 5 5 5 0 0 1 5 1 1

®
- PB 15:3 1 5 1 1 5 5 5 5 0 0 1 5 1 -

®
- PB 15:3 1 5 1 1 0 5 5 0 0 0 1 0 - -
Microlen Flame Red 3800 MCN

®
- PR 272 1 1 1 1 5 1 1 0 0 0 1 5 1 1
Microlen® Green 8730 MCN - PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5
Microlen® Green 8745 LW MCN - PG 7 5 5 1 5 5 5 5 5 0 0 5 5 1 5
Microlen Magenta 4535 MCN

®
- PR 202 1 5 1 5 5 1 1 5 0 0 1 5 1 1
Microlen Orange 2910 MCN

®
- PO 71 - - - - - - - - - - - - - -
Microlen Orange 2960 MP

®
Microlen Orange GP-MP
®
PO 64 1 1 1 5 1 1 1 5 0 0 1 5 1 1
Microlen® Pink 4430 MCN - PR 122 1 1 1 5 1 1 1 5 0 1 1 5 1 1
Microlen® Red 3840 LW MCN - PR 254 1 1 1 1 5 1 1 5 0 0 1 5 1 1
Microlen Red 3840 MCN

®
- PR 254 1 1 1 1 1 1 1 5 0 5 1 5 1 1
Microlen Red 3845 LW MCN

®
- PR 254 1 1 1 1 1 1 1 0 0 1 1 5 1 1

®
- PR 144 1 1 1 5 5 1 1 0 0 0 1 5 1 1

Colorants for

EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Microlen® Red 3890 MCNQ - PR 144 1 1 1 5 5 1 1 0 0 0 1 5 1 1
Microlen® Red 4060 MCN - PR 48:3 5 1 1 5 0 1 1 0 0 0 1 0 - 1
Microlen® Red 4104 MCN - PV 19 1 1 1 5 1 1 1 5 0 0 1 5 1 1

®
- PR 48:2 1 1 1 5 1 1 1 0 0 5 1 5 1 1

®
- - 1 1 1 5 0 1 1 5 0 0 1 5 1 1
Microlen Rubine 4085 MCN

®
- PR 264 1 1 1 1 5 1 1 0 0 0 1 5 1 -
Microlen® Rubine 4270 MCN - PR 57:1 1 1 1 5 1 1 1 0 0 1 1 0 - 1
Microlen® Violet 5700 MCN - PV 37 1 1 1 5 1 1 1 0 0 0 1 5 1 1
Microlen Yellow 1070 MCN

®
- PY 168 1 1 1 5 5 1 1 0 0 0 1 5 1 1

®
- PY 93 1 1 1 5 1 1 1 5 0 0 1 5 1 1

®
- PY 180 1 1 1 5 1 1 1 5 0 0 1 5 1 1
Microlen® Yellow 1500 MCN - PY 95 1 1 1 5 1 1 1 5 0 0 1 5 1 1
Microlen® Yellow 2070 MCN - PY 110 1 1 1 5 5 1 1 5 0 5 1 5 1 -
Microlith Blue 7080 KP

®
Microlith Blue 4G-KP
®
PB 15:3 1 5 1 1 5 5 5 0 0 1 1 0 - -
Microlith Brown 3001 KP

®
Microlith Brown 5R-KP
®
PBr 23 1 5 1 5 5 5 5 0 0 5 1 0 - -
Microlith Red 3840 KP

®
Microlith DPP Red B-KP
®
PR 254 1 5 1 1 5 5 5 0 0 5 1 0 - -
Microlith® Red 3890 KP Microlith® Red BR-KP PR 144 1 5 1 5 5 5 5 0 0 5 1 0 - -
Microlith® Scarlet 3540 KP Microlith® Scarlet R-KP PR 166 1 5 1 5 5 5 5 0 0 5 1 0 - -
Microlith Violet 5700 KP

®
- PV 37 1 5 1 5 5 5 5 0 0 0 1 0 - 1
Microlith Yellow 1210 KP

®
Microlith Yellow 3G-KP
®
PY 93 1 5 1 5 5 5 5 0 0 5 1 0 - -
Microlith Yellow 2060 KP

®
Microlith Yellow 3R-KP
®
PY 110 1 5 1 5 5 5 5 0 0 5 1 0 - -
Oracet® Blue 690 Oracet® Blue PD2104 SB 104 1 1 1 5 1 1 1 5 0 0 1 5 1 1
Oracet® Blue 780 FE Filester® Blue GN SB 67 1 5 1 1 5 5 5 0 5 0 1 0 - -
Oracet Magenta 460

®
Oracet Red 5B
®
SR 52 1 1 1 5 1 1 1 0 5 0 1 5 1 -
Oracet Orange 220

®
Oracet Orange ES
®
SO 116 1 1 1 5 0 1 1 0 0 0 1 0 - -
Oracet Orange 230

®
Oracet Orange G
®
SO 60 1 1 1 5 5 1 1 5 5 0 1 5 1 1
Oracet® Red 344 Oracet® Red GN SR 135 1 1 1 5 5 1 1 5 5 0 1 5 1 1
Oracet® Red 454 Thermoplast® Red 454 SR 195 1 1 1 5 0 1 1 0 0 0 1 5 1 1
Oracet Yellow 125

®
Oracet Yellow PD 2114
®
SY 114 1 1 1 5 1 1 1 0 0 0 1 5 1 1
Oracet Yellow 130

®
- SY 93 1 1 1 1 1 1 1 0 5 0 1 5 1 1
Oracet Yellow 140

®
Oracet Yellow RB
®
PY 147 1 1 1 5 5 1 1 5 5 5 1 5 1 -

Colorants for

EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Oracet® Yellow 144 FE Filester® Yellow RNB PY 147 1 1 1 5 5 1 1 5 5 5 1 5 1 1
Oracet® Yellow 180 Oracet® Yellow GHS SY 163 1 1 1 5 5 1 1 0 5 0 1 5 1 -
Paliogen® Red K 3911 Paliogen® Red K 3911 HD PR 178 5 1 1 5 1 1 1 5 5 0 1 5 1 -
Paliogen Red K 4180

®
- PR 179 1 1 1 1 0 1 1 5 5 0 1 5 1 -
Paliotol Orange K 2920

®
- PO 79 1 1 1 5 0 1 1 5 0 0 1 0 - 1
Paliotol Yellow K 0961

®
Paliotol Yellow K 0961 HD
®
PY 138 5 1 1 5 5 5 5 5 5 5 5 5 1 5
Paliotol® Yellow K 1070 Irgalite® Yellow WGP PY 168 1 1 1 5 5 1 1 0 5 0 1 5 1 1
Paliotol® Yellow K 1090 - PY 138 5 1 1 5 5 5 5 5 0 5 5 5 1 -

®
- PY 229 1 1 1 5 0 1 1 - - - 1 - - -
Paliotol Yellow K 1760 FP

®
Cromophtal Yellow HRPN
®
PY 191:1 1 5 1 5 5 5 5 5 0 0 1 5 1 1

®
®
PY 183 1 1 1 5 1 1 1 5 5 0 1 5 1 1
Paliotol® Yellow K 1841 - PY 139 5 1 1 1 0 1 1 0 5 0 1 0 - 1
Paliotol® Yellow K 1841 FP - PY 139 5 1 1 1 0 1 1 0 5 0 1 0 - 1
Rightﬁt Red K 3790

®
- PR 276 1 1 1 5 0 1 1 5 0 0 1 0 - -

®
- PR 277 1 1 1 5 0 1 1 5 0 0 1 0 - -
Sicopal Black K 0095

®
- PBr 29 1 5 1 1 0 5 5 0 0 0 1 0 - 1
Sicopal® Blue K 6210 - PB 28 1 5 1 1 5 5 5 5 0 1 1 5 1 1
Sicopal® Blue K 6310 - PB 28 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Sicopal Blue K 7210

®
- PB 36 1 5 1 1 5 5 5 0 5 0 1 5 1 -
Sicopal Brown K 2595

®
- PY 119 1 5 1 1 5 5 5 0 5 0 1 5 1 -
Sicopal Brown K 2795

®
- PBr 29 1 5 1 1 0 5 5 0 5 0 1 0 - 1
Sicopal® Brown K 2795 FG - PBr 29 1 5 1 1 0 5 5 0 0 0 1 0 - 1
Sicopal® Green K 9715 FK - PG 50 1 5 1 1 5 5 5 5 0 0 1 5 1 -
Sicopal Orange K 2430

®
- PO 82 1 5 1 1 0 5 5 0 0 0 1 0 - -
Sicopal Yellow 1120 FG

®
- PY 184 1 5 1 1 0 5 5 0 0 0 1 0 - -
Sicotan Brown K 2611

®
- PY 164 1 5 1 1 0 5 5 0 0 0 1 0 - 1
Sicotan® Brown K 2711 - PY 164 1 5 1 1 0 5 5 0 0 0 1 0 - -
Sicotan® Yellow K 1010 - PY 53 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Sicotan Yellow K 1011

®
- PY 53 1 5 1 1 5 5 5 5 5 1 1 5 1 1
Sicotan Yellow K 1011 FG

®
- PY 53 1 5 1 1 5 5 5 5 0 1 1 5 1 1

®
- PBr 24 1 1 1 1 1 1 1 5 5 0 1 5 1 1

Colorants for

EC - Art. 3 10/2011 BfR IX Art. 3.1
1227 847/2011 21/3/73 N° 15/2010
Sicotan® Yellow K 2001 FG - PBr 24 1 1 1 1 1 1 1 5 5 0 1 5 1 -
Sicotan® Yellow K 2011 - PBr 24 1 1 1 1 1 1 1 5 5 0 1 5 1 -
Sicotan® Yellow K 2011 FG - PBr 24 1 1 1 1 1 1 1 5 0 0 1 5 1 1

®
- PBr 24 1 1 1 1 1 1 1 5 5 0 1 5 1 -

®
- PBr 24 1 5 1 1 5 5 5 5 5 0 1 5 1 1

®
- PBr 24 1 5 1 1 5 5 5 5 0 0 1 5 1 1
Sicotan® Yellow K 2112 - PBr 24 1 5 1 1 5 5 5 5 5 0 1 5 1 -
Sicotan® Yellow K 2112 FG - PBr 24 1 5 1 1 5 5 5 5 0 0 1 5 1 -
Sicotrans Red K 2819

®
- PR 101 1 5 1 1 5 5 5 5 5 1 1 5 1 -
Sicotrans Red K 2915

®
- PR 101 1 5 1 1 5 5 5 5 5 1 1 5 1 1

Colorants for toys
Colorants
for toys
Status as of September 2017
This portfolio is regularly reviewed according to business needs and regulatory

requirements. For any updates please contact the pigments-safety@basf.com mailbox.
The overview of products’ status in the table below should be used as a guide only.
In any case, it does not replace the product detailed information contained in specific
statements about toys applications.
For more detailed information on specific country or application requirements,

please contact us via pigments-safety@basf.com.
Please note that in EU, toys for children under 3 years and toys for mouth contact
have to fulfill Article 3 of the Framework Regulation (EC) No. 1935/2004.
30 Colorants for toys
Colorants for toys
Colorants
for toys
1 Compliant 5 Compliant with use restrictions* 0 Not compliant 1 Compliant 5 Compliant with use restrictions* 0 Not compliant
Status: September 2017 SST Status Statement Toys (EN 71-3:2013 Heavy Metal Status Statement) Status: September 2017 SST Status Statement Toys (EN 71-3:2013 Heavy Metal Status Statement)
Toys for Toys for

children under children under
Toys for children above 3 years Toys for children above 3 years
3 years and 3 years and
and no mouth contact and no mouth contact
toys for mouth toys for mouth
C.I. contact C.I. contact
Product Old product name Product Old product name
name name
European European
Europe USA Australia Europe USA Australia
Union Union
1935/2004/ Norm 71- Norm 71- ASTM F AS/NZS 1935/2004/ Norm 71- Norm 71- ASTM F AS/NZS
EC - Art. 3 3, 2002 3, 2013 963-11 ISO8124.3:2003 EC - Art. 3 3, 2002 3, 2013 963-11 ISO8124.3:2003
Cinquasia® Magenta K 4535 Cinquasia® Magenta RT-235-D PR 202 1 1 1 1 1 Eupolen® PE Blue 69-1501 - PB 15:1 5 1 1 1 1
Cinquasia Magenta K 4535 FP

®
Cromophtal Magenta P
®
PR 202 1 1 1 1 1 Eupolen PE Blue 69-2001
®
- PB 15:1 1 1 1 1 1
Cinquasia® Pink K 4410 Cromophtal® Pink 2000 PR 122 1 1 1 1 1 Eupolen® PE Blue 69-2004 - PB 15:1 1 1 1 1 1
Cinquasia® Pink K 4430 FP Cromophtal® Pink PT PR 122 1 1 1 1 1 Eupolen® PE Blue 69-2005 - PB 15:1 1 1 1 1 1
Cinquasia® Red K 4104 Cromophtal® Red 2020 PV 19 1 1 1 1 1 Eupolen® PE Blue 70-9001 - PB 15:3 1 1 1 1 1

®
Cromophtal Red TBR
®
PV 19 1 1 1 1 1 Eupolen PE Blue 70-9004
®
- PB 15:3 1 1 1 1 1

®
Cinquasia Red B RT-195-D
®
- 1 1 1 1 1 Eupolen PE Blue 70-9005
®
- PB 15:3 1 1 1 1 1
Cinquasia® Violet K 5350 Cinquasia® Violet R RT-891-D PV 19 1 1 1 1 1 Eupolen® PE Blue 71-0401 - PB 15:4 1 1 1 1 1
Cinquasia® Violet K 5350 FP Cromophtal® Violet RP PV 19 1 1 1 1 1 Eupolen® PE Brown 29-1505 - PR 101 1 1 1 1 1
Cromophtal® Brown K 3001 Cromophtal® Brown 5R PBr 23 1 1 1 1 1 Eupolen® PE Green 87-3001 - PG 7 5 1 1 1 1
Cromophtal Orange K 2960

®
Cromophtal Orange GP
®
PO 64 1 1 1 1 1 Eupolen PE Green 87-3004
®
- PG 7 5 1 1 1 1

®
Cromophtal Red G
®
PR 220 1 1 1 1 1 Eupolen PE Green 87-3005
®
- PG 7 5 1 1 1 1
Cromophtal® Red K 3890 Cromophtal® Red BRN PR 144 1 1 1 1 1 Eupolen® PE Green 87-3501 - PG 7 5 1 1 1 1
Cromophtal® Red K 3890 FP Cromophtal® Red BRNP PR 144 1 1 1 1 1 Eupolen® PE Green 93-6001 - PG 36 5 1 1 1 1
Cromophtal® Red K 3900 Cromophtal® Red BN PR 214 1 1 1 1 1 Eupolen® PE Red 39-1101 - PR 178 1 1 1 1 1

®
Cromophtal Red BNFP
®
PR 214 1 1 1 1 1 Eupolen PE Red 47-9001
®
- PR 122 1 1 1 1 1

®
Cromophtal Red 2B
®
PR 221 1 1 1 1 1 Eupolen PE Yellow 09-6101
®
- PY 138 5 1 1 1 1
Cromophtal® Scarlet K 3540 Cromophtal® Scarlet RN PR 166 1 1 1 1 1 Eupolen® PE Yellow 11-5501 - PY 185 5 1 1 1 1
Cromophtal® Violet K 5700 Cromophtal® Violet B PV 37 1 1 1 1 1 Eupolen® PE Yellow 13-1501 - PY 215 1 1 1 1 1
Cromophtal® Yellow 2GF - PY 155 1 1 1 1 1 Eupolen® PE Yellow 17-6001 - PY 191:1 1 1 1 1 1

®
Cromophtal Yellow 8GN
®
PY 128 1 1 1 1 1 Eupolen PE Yellow 17-6004
®
- PY 191:1 1 1 1 1 1
Cromophtal Yellow K 0990 FP

®
Cromophtal Yellow 8GNP
®
®
®
PY 183 1 1 1 1 1
Cromophtal® Yellow K 1210 Cromophtal® Yellow 3G PY 93 1 1 1 1 1 Eupolen® PE Yellow 18-4101 - PY 139 5 1 1 1 1
Cromophtal® Yellow K 1210 FP Cromophtal® Yellow 3GNP PY 93 1 1 1 1 1 Eupolen® PE Yellow 18-4104 - PY 139 5 1 1 1 1
Cromophtal® Yellow K 1310 Cromophtal® Yellow 4GV PY 215 1 1 1 1 1 Eupolen® PE Yellow 18-4105 - PY 139 5 1 1 1 1

®
Cromophtal Yellow 2GO
®
®
- PY 110 1 1 1 1 1

®
Cromophtal Yellow GR
®
PY 95 1 1 1 1 1 Firemist Blue 9G630L
®
- - 1 1 1 1 1
Cromophtal® Yellow K 1500 FP Cromophtal® Yellow GRP PY 95 1 1 1 1 1 Firemist® Gold 9G230L - - 1 1 1 1 1
* For more information please contact pigments-safety@basf.com * For more information please contact pigments-safety@basf.com
Colorants for toys
Colorants
for toys
Toys for Toys for

name name
European European
Union Union
Firemist® Green 9G830L - - 1 1 1 1 1 Irgalite® Red K 4170 FP Irgalite® Red 2BP PR 48:2 1 1 1 1 1
Firemist Pearl 9G130L

®
- - 1 1 1 1 1 Irgalite Rubine K 4270 FP
®
Irgalite Rubine 4BP
®
PR 57:1 1 1 1 1 1
Firemist Red 9G430L

®
- - 1 1 1 1 1 Irgalite Scarlet K 4165
®
- PR 48:3 5 1 SST 1 1
Firemist® Turquoise 9G730L - - 1 1 1 1 1 Irgazin® Flame Red K 3800 Cromophtal® DPP Flame Red FP PR 272 1 1 1 1 1
Firemist® Violet 9G530L - - 1 1 1 1 1 Irgazin® Orange K 2890 Cromophtal® Orange 2G PO 61 1 1 1 1 1
Glacier Crystal White EH 1030

®
- - 1 1 1 1 1 Irgazin Orange K 2910
®
Cromophtal DPP Orange TRP
®
PO 71 1 1 1 1 1
Glacier Frost White 9S130D

®
- - 1 1 1 1 1 Irgazin Red K 3840
®
Cromophtal Red 2030
®
PR 254 1 1 1 1 1
Glacier Silk White EH 2012

®
®
Cromophtal Red 2028
®
PR 254 1 1 1 1 1
- - 1 1 1 1 1
(9S130V)
Irgazin® Red K 3840 SQ Cromophtal® Red 1030-P PR 254 1 1 1 1 1
Glacier® Sparkle White EH 1060 - - 1 1 1 1 1
Irgazin® Red K 3842 Cromophtal® DPP Red BP PR 254 1 1 1 1 1
Heliogen® Blue K 6850 - PB 15 1 1 1 1 1
Irgazin Red K 3845
®
Irgazin DPP Red BO
®
PR 254 1 1 1 1 1
Heliogen® Blue K 6860 - PB 15 1 1 1 1 1
®
Cromophtal DPP Red BOC
®
PR 254 1 1 1 1 1
Heliogen® Blue K 6902 - PB 15:1 1 1 1 1 1
®
Cromophtal Rubine TR
®
- 1 1 1 1 1
Irgazin® Rubine K 4085 Irgazin® Rubine L 4025 PR 264 1 1 1 1 1
Irgazin® Yellow K 2060 - PY 110 1 1 1 1 1
Heliogen® Blue K 6911 Heliogen® Blue K 6911 D PB 15:1 1 1 1 1 1
Irgazin Yellow K 2060 FP
®
Cromophtal Yellow 3RLP
®
PY 110 1 1 1 1 1
Heliogen® Blue K 6912 FP - PB 15:1 1 1 1 1 1
Irgazin Yellow K 2060 SQ
®
- PY 110 1 1 1 1 1
®
Cromophtal Yellow 2RLTS
®
PY 110 1 1 1 1 1
Irgazin® Yellow K 2080 Cromophtal® Yellow 2RLP PY 110 1 1 1 1 1
Heliogen® Blue K 7090 FP - PB 15:3 1 1 1 1 1
Lumina® Aqua Blue 9A30D - - 1 1 1 1 1
Heliogen® Blue K 7097 Cromophtal® Blue 4GNP. PB 15:3 1 1 1 1 1
Lumina Brass 9232D
®
- - 1 1 1 1 1
Heliogen® Blue K 7104 LW - PB 15:4 1 1 1 1 1
Lumina Gold 9Y30D
®
- - 1 1 1 1 1
Heliogen® Green K 8683 - PG 7 5 1 1 1 1
Lumina Green 9G30D
®
- - 1 1 1 1 1
Heliogen® Green K 8730 - PG 7 5 1 1 1 1
Lumina® Red 9R30D - - 1 1 1 1 1
Heliogen® Green K 8730 FP - PG 7 5 1 1 1 1
Lumina® Red Blue 9B30D - - 1 1 1 1 1
Heliogen® Green K 8730 Z - PG 7 5 1 1 1 1
Lumina Royal Aqua Blue 9780H
®
- - 1 1 1 1 1
Heliogen® Green K 8740 Heliogen® Green K 8740 LW PG 7 5 1 1 1 1
Lumina Royal Blue 9680H
®
- - 1 1 1 1 1
Heliogen® Green K 9360 FK - PG 36 5 1 1 1 1
Lumina Royal Copper 9390H
®
- - 1 1 1 1 1
Irgalite® Red K 4060 FP Irgalite® Red 2BSP PR 48:3 5 1 SST 1 1
Colorants for toys
Colorants
for toys
Toys for Toys for

name name
European European
Union Union
Lumina® Royal Indigo 9580H - - 1 1 1 1 1 Mearlin® Micro Bronze 9250M - - 1 1 1 1 1
Lumina Royal Magenta EH 5001

®
- - 1 1 1 1 1 Mearlin Satin White 9130 F
®
- - 1 1 1 1 1
Lumina Turquoise 9T30D

®
- - 1 1 1 1 1 Mearlin Satin White 9130 F DF-70
®
- - 1 1 1 1 1
Magnapearl® 1000 - - 1 1 1 1 1 Mearlin® Sparkle Blue 9620 J - - 1 1 1 1 1
Magnapearl® 1000 DF-70 - - 1 1 1 1 1 Mearlin® Sparkle Brass 9222 J - - 1 1 1 1 1
Magnapearl 1100
®
- - 1 1 1 1 1 Mearlin Sparkle Bronze 9250 J
®
- - 1 1 1 1 1
Magnapearl 1110
®
- - 1 1 1 1 1 Mearlin Sparkle Copper 9350 J
®
- - 1 1 1 1 1
Magnapearl 2000
®
- - 1 1 1 1 1 Mearlin Sparkle Gold 9212 P
®
- - 1 1 1 1 1
Magnapearl® 2000 DF-70 - - 1 1 1 1 1 Mearlin® Sparkle Gold 9220 J - - 1 1 1 1 1
Magnapearl® 2100 - - 1 1 1 1 1 Mearlin® Sparkle Green 9820 J - - 1 1 1 1 1
Magnapearl 2110
®
- - 1 1 1 1 1 Mearlin Sparkle Orange 9320 J
®
- - 1 1 1 1 1

®
- - 1 1 1 1 1 Mearlin Sparkle Red 9420 J
®
- - 1 1 1 1 1
Magnapearl 2300
®
- - 1 1 1 1 1 Mearlin Sparkle Russet 9450 J
®
- - 1 1 1 1 1
Magnapearl® 2300 DF-70 - - 1 1 1 1 1 Mearlin® Sparkle Violet 9520 J - - 1 1 1 1 1
Magnapearl® 3000 - - 1 1 1 1 1 Mearlin® Super Blue 9630 Z - - 1 1 1 1 1
Magnapearl 3100
®
- - 1 1 1 1 1 Mearlin Super Blue-Russet 9650 Z
®
- - 1 1 1 1 1

®
- - 1 1 1 1 1 Mearlin Super Brass 9232 Z
®
- - 1 1 1 1 1
Magnapearl 4000
®
- - 1 1 1 1 1 Mearlin Super Bronze 9250 Z
®
- - 1 1 1 1 1
Magnapearl® 4000 DF-70 - - 1 1 1 1 1 Mearlin® Super Copper 9350 Z - - 1 1 1 1 1
Magnapearl® 5000 - - 1 1 1 1 1 Mearlin® Super Gold 9230 Z - - 1 1 1 1 1
Magnapearl 8000
®
- - 1 1 1 1 1 Mearlin Super Green 9830 Z
®
- - 1 1 1 1 1
Mearlin Aztec Gold 9363 C

®
- - 1 1 1 1 1 Mearlin Super Orange 9330 Z
®
- - 1 1 1 1 1
Mearlin Brilliant Gold 9212 G

®
- - 1 1 1 1 1 Mearlin Super Red 9430 Z
®
- - 1 1 1 1 1
Mearlin® Copper 9340 A - - 1 1 1 1 1 Mearlin® Super Russet 9450 Z - - 1 1 1 1 1
Mearlin® Inca Gold 9222 G - - 1 1 1 1 1 Mearlin® Super Sparkle 9110 S - - 1 1 1 1 1

®
- - 1 1 1 1 1 Mearlin Super Violet 9530 Z
®
- - 1 1 1 1 1

®
Mearlin Super White 9020 C
®
- - 1 1 1 1 1
- - 1 1 1 1 1
DF-70
Meteor Yellow 9379 FF FK
®
- - 1 1 SST 1 1
Mearlin® Mayan Gold 9233 X - - 1 1 1 1 1
Colorants for toys
Colorants
for toys
Toys for Toys for

name name
European European
Union Union
Microlen® Black 0068 MCN - PBk 7 1 1 1 1 1 Microlen® Yellow 1410 MCN - PY 180 1 1 1 1 1

®
- PB 15:1 1 1 1 1 1 Microlen Yellow 1500 MCN
®
- PY 95 1 1 1 1 1

®
- PB 15:1 1 1 1 1 1 Microlen Yellow 2070 MCN
®
- PY 110 1 1 1 1 1
Microlen® Blue 6916 MCN - PB 15:1 1 1 1 1 1 Microlith® Blue 7080 KP Microlith® Blue 4G-KP PB 15:3 1 1 1 1 1
Microlen® Blue 7079 MCN - PB 15:3 1 1 1 1 1 Microlith® Brown 3001 KP Microlith® Brown 5R-KP PBr 23 1 1 1 1 1

®
- PB 15:3 1 1 1 1 1 Microlith Red 3840 KP
®
Microlith DPP Red B-KP
®
PR 254 1 1 1 1 1

®
- PB 15:3 1 1 1 1 1 Microlith Red 3890 KP
®
Microlith Red BR-KP
®
PR 144 1 1 1 1 1
Microlen Flame Red 3800 MCN

®
- PR 272 1 1 1 1 1 Microlith Scarlet 3540 KP
®
Microlith Scarlet R-KP
®
PR 166 1 1 1 1 1
Microlen® Green 8730 MCN - PG 7 5 1 1 1 1 Microlith® Violet 5700 KP - PV 37 1 1 1 1 1
Microlen® Green 8745 LW MCN - PG 7 5 1 1 1 1 Microlith® Yellow 1210 KP Microlith® Yellow 3G-KP PY 93 1 1 1 1 1
Microlen Magenta 4535 MCN

®
- PR 202 1 1 1 1 1 Microlith Yellow 2060 KP
®
Microlith Yellow 3R-KP
®
PY 110 1 1 1 1 1
Microlen Orange 2910 MCN

®
- PO 71 - - - - - Oracet Blue 690
®
Oracet Blue PD2104
®
SB 104 1 1 1 1 1
Microlen Orange 2960 MP

®
- PO 64 1 1 1 1 1 Oracet Blue 780 FE
®
Filester Blue GN SB 67 1 1 1 1 1
Microlen® Pink 4430 MCN - PR 122 1 1 1 1 1 Oracet® Magenta 460 Oracet Red 5B SR 52 1 1 1 1 1
Microlen® Red 3840 LW MCN - PR 254 1 1 1 1 1 Oracet® Orange 220 Oracet® Orange ES SO 116 1 1 1 1 1

®
- PR 254 1 1 1 1 1 Oracet Orange 230
®
Oracet Orange G
®
SO 60 1 1 1 1 1
Microlen Red 3845 LW MCN

®
- PR 254 1 1 1 1 1 Oracet Red 344
®
Oracet Red GN
®
SR 135 1 1 1 1 1

®
- PR 144 1 1 1 1 1 Oracet Red 454
®
Thermoplast Red 454
®
SR 195 1 1 1 1 1
Microlen® Red 3890 MCNQ - PR 144 1 1 1 1 1 Oracet® Violet 580 Oracet® Violet TR SV 13 1 1 1 1 1
Microlen® Red 4060 MCN - PR 48:3 5 1 SST 1 1 Oracet® Yellow 125 Oracet® Yellow PD 2114 SY 114 1 1 1 1 1

®
- PV 19 1 1 1 1 1 Oracet Yellow 130
®
Oracet Yellow 3GN
®
SY 93 1 1 1 1 1

®
- PR 48:2 1 1 1 1 1 Oracet Yellow 140
®
Oracet Yellow RB
®
PY 147 1 1 1 1 1

®
- - 1 1 1 1 1 Oracet Yellow 144 FE
®
Filester Yellow RNB
®
PY 147 1 1 1 1 1
Microlen® Rubine 4085 MCN - PR 264 1 1 1 1 1 Oracet® Yellow 180 Oracet® Yellow GHS SY 163 1 1 1 1 1
Microlen® Rubine 4270 MCN - PR 57:1 1 1 1 1 1 Paliogen® Red K 3911 Paliogen® Red K 3911 HD PR 178 1 1 1 1 1
Microlen Violet 5700 MCN

®
- PV 37 1 1 1 1 1 Paliogen Red K 4180
®
- PR 179 1 1 1 1 1

®
- PY 168 1 1 1 1 1 Paliotol Orange K 2920
®
- PO 79 1 1 1 1 1

®
- PY 93 1 1 1 1 1 Paliotol Yellow K 0961
®
Paliotol Yellow K 0961 HD
®
PY 138 5 1 1 1 1
Legislation for food contact materials
Colorants
for toys
Toys for Toys for children under 3 years Toys for children above 3 years
children under and toys for mouth contact and no mouth contact
Toys for children above 3 years
3 years and Old product C.I.
and no mouth contact Product European Union Europe USA Australia
toys for mouth name name
C.I. contact Norm 71- Norm 71- ASTM F AS/NZS
Product Old product name 1935/2004/EC - Art. 3
name 3, 2002 3, 2013 963-11 ISO8124.3:2003
European
Europe USA Australia
Union Sicotan® Yellow K 2011 FG - PBr 24 1 1 SST 1 1
1935/2004/ Norm 71- Norm 71- ASTM F AS/NZS
Sicotan® Yellow K 2107 - PBr 24 1 1 SST 1 1
EC - Art. 3 3, 2002 3, 2013 963-11 ISO8124.3:2003
Paliotol® Yellow K 1070 Irgalite® Yellow WGP PY 168 1 1 1 1 1
®
- PBr 24 1 1 SST 1 1
Paliotol® Yellow K 1090 - PY 138 1 1 1 1 1
®
- PBr 24 1 1 SST 1 1
®
- PBr 24 1 1 SST 1 1
Paliotol® Yellow K 1760 FP Cromophtal® Yellow HRPN PY 191:1 1 1 1 1 1
Sicotrans® Red K 2819 - PR 101 1 1 1 1 1
Paliotol® Yellow K 1800 Paliotol® Yellow K 2270 PY 183 1 1 1 1 1
Sicotrans® Red K 2915 - PR 101 1 1 1 1 1
Paliotol® Yellow K 1841 FP - PY 139 5 1 1 1 1 * For more information please contact pigments-safety@basf.com
Rightﬁt® Red K 3790 - PR 276 1 1 1 1 1

®
- PR 277 1 1 1 1 1
Sicopal® Black K 0095 - PBr 29 1 1 SST 1 1
Sicopal® Blue K 6210 - PB 28 1 1 SST 1 1
Sicopal Blue K 6310

®
- PB 28 1 1 SST 1 1 EU legislation
Sicopal® Blue K 7210 - PB 36 1 1 SST 1 1
European regulations are directly binding to all 28 member Union, some countries within Europe are transforming
Sicopal® Brown K 2595 - PY 119 1 1 SST 1 1 states. In addition to the direct members of the European these regulations into their national law, e.g., Switzerland.
Sicopal® Brown K 2795 - PBr 29 1 1 SST 1 1
Regulation (EC) No. 1935/2004
Sicopal Brown K 2795 FG
®
- PBr 29 1 1 SST 1 1 Framework
Sicopal® Green K 9715 FK - PG 50 1 1 SST 1 1
Sicopal® Orange K 2430 - PO 82 1 1 SST 1 1 Regulation (EC) No. 2023/2006

Good Manufacturing Practice
Sicopal® Yellow 1120 FG - PY 184 1 1 SST 1 1 Applicable to all Food Contact
Sicotan® Brown K 2611 - PY 164 1 1 SST 1 1
Sicotan® Brown K 2711 - PY 164 1 1 SST 1 1

Directive Directive Plastic material Regulation (EC) Regulation (EC) Regulation (EC) Elastomers Regulation (EC)
2007/42/EC 84/500EEC 372/2007 No. 282/2008 1895/2005 and rubbers No. 450/2009
Sicotan Brown K 2755
®
- PY 53 1 1 SST 1 1 Regenerated Ceramics Transition migration Recycled Plastics BADGE/BFDGE/ Active & Intelligent
Regulation (EU)
Cellulose Film limits for plasticizers NOGE Packaging
Sicotan® Yellow K 1010 - PY 53 1 1 SST 1 1 No. 10/2011
Directive in gaskets in lids Directive
2005/31/EC 93/11/EEC
Sicotan® Yellow K 1011 - PY 53 1 1 SST 1 1 1st amendment Nitrosamines
Sicotan® Yellow K 1011 FG - PY 53 1 1 SST 1 1

®
- PBr 24 1 1 SST 1 1
Sicotan® Yellow K 2001 FG - PBr 24 1 1 SST 1 1 Glass Paper & Wood Metals & Cork lon-exchange Textiles Adhesives Printing Silicones Varnishes & Waxes
board alloys resins inks coatings
Figure 1: Overview of the EU legislation for food contact materials
40 Legislation for food contact materials
All food contact materials and articles Plastic food contact materials and articles §§ Overall migration limit (OML) For all materials, the requirement is present that they
It means the maximum permitted amount of non- should not transfer their constituents to foodstuffs in
Regulation (EC) No. 1935/2004, the framework regu- Regulation (EU) No. 10/2011 on plastic materials and volatile substances released from a material or article quantities that could endanger human health, bring
lation on materials and articles intended to come into articles intended to come into contact with food, and into food simulants. According to Article 12 plastic about an unacceptable change in the composition or
contact with food, sets general requirements for all with additional amendments, sets the rules for plastic materials and articles intended to be brought into deterioration of organoleptic characteristics. Specific
food contact materials. food contact materials. This regulation is commonly contact with food shall not transfer their constituents requirements are set in the supplementary technical
known as the “PIM” or Plastics Implementation to food simulants in quantities exceeding 60 mg/kg documents and substance inventories can be found
The framework regulation sets following rules: Measure. It is one of the implementing measures (OML) of food simulant in the Appendixes of the resolutions. The substance
mandated by the framework regulation and §§ Rules on compliance, especially migration testing, inventories are based on notifications by industry or
§§ General safety principles addresses plastics specifically. listing simulants, testing conditions national authorities. Listed substances have not
§§ Groups of food contact materials and articles §§ The concept of functional barrier necessarily been risk assessed.
The regulation entered in force on May 11, 2011, and
§§ Procedure for authorization §§ Authorization for nano-materials before use
foresees transitional provisions up to January 1, 2016. All resolutions are not legally binding. They have the
§§ Establishment of a European Reference Laboratory By then all food contact materials and articles on the Declaration of compliance and supporting character of a guideline, as long as they are not trans-
for food contact materials market will have to fulfill the requirements of the Regu- documentation As mentioned in the Union Guideline ferred into national law.
§§ Mandates the development of implementing lation (EU) No. 10/2011. to Regulation (EU) No. 10/2011 published in February
measures for specific requirements 2014: “Even though colorants fall under the definition Resolution AP (89) 1
What the regulation covers of additives, they are not covered by the Union list of
General safety principles of the framework substances. Colorants used in plastics are covered Resolution AP (89) 1 applies to the use of colorants in
regulation §§ Plastic materials and articles, whether printed and by national measures. However, they have to comply plastic materials and articles coming into contact with
coated or not with the general safety requirements of Article 3 of the food. The resolution defines purity requirements for
The framework regulation – in force since December 3, §§ Plastic multi-layer materials and articles held to- Framework Regulation (EC) No. 1935/2004 and are pigments including concentration limits for extractable
2004 – requires that food contact materials: gether by adhesives or by other means, whether subject to risk assessment in accordance with Article heavy metals, primary aromatic amines (PAA) and
printed and coated or not 19* of the Plastics Regulation (EU) No. 10/2011.” polychlorinated biphenyls (PCB).
§§ Meet Article 3 of the regulation: Must not transfer
their components into food in quantities that could §§ Plastic layers or plastic coatings, forming gaskets in
Compliance with Article 3 of regulation (EC) No. Soluble metal and metalloids Limit [ppm]
endanger human health, change food composition caps and closures, that make a set of two or more
1935/2004 of substances referred to in Articles 6(1), Antimony (Sb) 500
in an unacceptable way or deteriorate its taste and layers of different types of materials
6(2), 6(4), 6(5) and 14(2) of this regulation, which are
odor. §§ Plastic layers in multi-material multi-layer materials Arsenic (As) 100
not covered by an inclusion in Annex I to this regulation
§§ Are manufactured according to good manufacturing and articles shall be assessed in accordance with internationally Barium (Ba) 100
practice as detailed in The Good Manufacturing recognized scientific principles on risk assessment. Cadmium (Cd) 100
Practice Regulation (EC) No. 2023/2006 that sets Rules set by the regulation
down the requirements/principles of good manufac- Chromium (Cr III) 1,000
turing practices for all food contact materials and §§ Union list (Annex I) of authorized monomers and Lead (Pb) 100
articles. additives for use in plastics manufacture Council of Europe resolutions Mercury (Hg) 50
§§ An article intended for food contact must be labelled §§ Restrictions and specification for authorized substan-
or bear the glass-and-fork symbol. This labelling The Council of Europe has established general recom- Selenium (Se) 100
ces including specific migration limits (SML) defined
is not obligatory if food contact is obvious by the based on toxicological evaluation and exposure mendations for various types of materials that are fre- Primary aromatic amines (PAA) 500
article’s nature, e.g., knife, fork, wine glass. scenario. According to EFSA Note for Guidance, quently used in the production, distribution, processing
Polychlorinated biphenyls (PCB) 25
§§ Labelling, advertising and presentation of food substances for which no specific migration limit or and consumption of foodstuffs. The following (non-
contact materials must not mislead consumers. other restrictions are provided in Annex I, a generic plastic) materials have been addressed: coatings, cork, Table 2: Purity limits of AP(89) 1
§§ Accompanied by a “Declaration of Compliance” specific migration limit of 60 mg/kg needs to be glass, inks, metals and alloys, paper and board, resins
containing information on the appropriate use of food observed for ion exchange and adsorption, rubber, silicones.
contact materials or articles, if necessary. (Article 16) §§ Rules on non-intentionally added substances,
§§ Are traceable throughout the production chain.Gene i.e., impurities and reaction products
* “Article 19” – Assessment of substances not included in the Union list

France Germany Australia Positive list of food contact additives and

colorants
The French Authority issued a document titled “Maté- In the updated BfR Recommendation IX (Status of AS 2070-1999: Plastic materials for food contact uses.
riaux au contact des denrées alimentaires, produits de February 1, 2015), colorants for plastic food con- The most important food safety standard for food
nettoyage de ces matériaux” – Edition (July 2002) No. tact materials are defined as coloring (chromophore) This standard specifies materials and the procedures contact additives in China is the revised GB 9685-2016
1227. substances including substances used as vehicles for use during the various stages of production of plas- “National food safety standards: Standard for use
or auxiliaries, as well as any technically unavoidable tic materials, coating and printing of plastic items for of additives in food contact materials and products”
French positive list for plastic materials contaminants. food contact and subsequent use. Part 9.2 deals with published in Octoter 2016, enforced on October, 19
colorants and states that colorants shall comply with 2017.
In Circular No. 176 of December 2, 1959, the French For the colorants, purity requirements with respect to the Council of Europe Resolution AP (89) 1.
Ministry of Agriculture published a list of colorants that limits for soluble metals in diluted hydrochloric acid The updated GB 9685 contains a compilation of
can be used for the coloration of food packaging in (stomach acid simulant) are established. Residual existing published versions and all MoH- and NHFPC
France. Since then, this list has frequently been revised. content of primary aromatic amines (PAA) in colorants Canada notices with all substance amendments since 2009,
For the complete list of pigments with their use limitations is not part of BfR IX purity requirements anymore. including newly petitioned substances approved since
(e.g., concentration, type of polymers, etc.) it is necessary Instead, PAA release into food needs to be determined The regulatory framework for packaging in Canada is then.
in each case to consult the document No. 1227. by the end article producer. The detection limit is set established by the Canadian Food and Drugs Act and
0.01 mg/kg and applies to the sum of the released related regulations. The additives positive list is split by application, i.e.
It should be noted that the colorants in the French PAA into food. Additionally, PAA classified as carcino- plastics, coatings, paper and board, inks, etc.
Positive List generally are listed according to their Color gens in classes 1A and 1B of the CLP Regulation (EC) Currently, under the Canadian Food and Drugs Act, Colorants are considered as "food contact additives"
Index classification (generic names and constitution 1272/2008 which, as individual substances, may not be premarked clearance of food packaging material is not and therefore must be listed under the appropriate
numbers). If not, it is under their CAS number (Chemical released with a detection limit of 0.002 mg/kg food or mandatory, except for infant formula, etc. Packaging application.
Abstract Service) and/or French chemical name. French food simulant. materials intended for use in contact with food can be
authorities have not yet established their country-specific submitted on a voluntary basis to the Health Products
rules into the European Union, where colorants them- In addition, any release into food of colorants or visible and Food Branch Directorate for safety evaluation. India
selves are not yet regulated. The establishment of these constituents is not allowed. If material is considered as safe for its intended use,
rules would require an official notification agreed by all then a letter of no objection ("LONO") is issued. At the In India, the new food safety and standards (packaging
member states in order to avoid the creation of poten Azo dyes, that can break down into primary aromatic moment, the "LONO" programm for food packaging and labelling) regulations became effective in 2011 brin-
tial trade barriers. amines classified as carcinogens in classes 1A and materials is under review. ging the food safety regulation to a federal level with the
1B of the CLP Regulation (EC) No. 1272/2008 are not new authority FSSAI. The major restrictions/ limitations
The current French positive list split in A and B (Projet allowed to be used in food contact materials. In case more information is required, please contact of a substance to be used for food contact materials
d’Arrêté) can be considered as a draft, and should be pigments-safety@basf.com. are still captured in the Indian Standards issued by
taken in the scope of a recommendation (non-complete the BIS Bureau of Indian Standards. The standard for
list). Nevertheless, the colorants have to fulfill the require Italy pigments and colorants can be found in the revised IS
ments of Article 3 of the Regulation (EC) No. 1935/2004. China 9833:2014 – List of Pigments & Colorants for Use in
In Italy, the national regulation Decreto Ministeriale Plastics in Contact with Foodstuffs, Pharmaceuticals &
March 21, 1973 as latest amended (Decree April 23, Regulatory framework in China Drinking Water. The revised standard is more stringent.
Spain 2009) has to be met for various food contact materials Purity requirements for heavy metals are based on total
like plastic, paper, rubber, etc. For colorants in plastic In China, food contact materials (FCMs) are regulated content according to Indian Standard IS 1699 and not
In Spain the national regulation Real Decreto 847/2011 food contact materials, purity limits are required in the under the Chinese Food Safety Law issued in 2009 on extractable heavy metals anymore.
has to be fulfilled for various food contact materials like same way as in the Council or Europe Resolution AP and recently revised Food Safety Law GB 4806.1-2016
plastic, etc. For colorants in plastic food contact materials (89) 1, i.e., heavy metals, primary aromatic amines coming into force on October 19, 2017. In case more information is required, please contact
purity limits have to be met analogous to Council of Europe (PAA) and polychlorinated biphenyls (PCB). pigments-safety@basf.com.
Resolution AP(89)1 i.e. heavy metals, primary aromatic Value chain stakeholders have to ensure the compli-
amines (PAA) and Polychlorinated Biphenyls (PCB). ance of raw materials and packaging by performing
risk assessment and issuing respective "Statement of
Conformity" (corresponds to DoC in EU).
Legislation on toys
Legislation on toys
Japan They have to meet the general provisions of § 174.5 and Europe Element Limit [ppm]
Section 402 applicable to indirect food additives, which Aluminum (Al) 5,625.00
In Japan, there are government regulations (e.g., Food are comparable to the requirements of Article 3 of the The Toy Safety Directive 2009/48/EC (TSD) provides
Antimony (Sb) 45.00
Sanitation Law) for food packaging and toys. The indus- Regulation (EC) No. 1935/2004. harmonized EU-wide standards on physical and me-
try has published recommendations that are accepted chanical properties, flammability, chemical and electrical Arsenic (As) 3.80
by all involved parties and conform to the regulations. The substances listed in paragraph (e) of 21 CFR properties, etc., of toys. Barium (Ba) 1,500.00
178.3297 may be safely used as colorants in the man
ufacture of articles or components of articles intended for Boron (B) 1,200.00
The Japan Hygienic PVC Association (JHPA) mentions The new TSD 2009/48/EC requires a series of safety
in its positive list for PVC the chemical constitutions as use in producing, manufacturing, packing, processing, assessments, including the Chemical Safety Assess- Cadmium (Cd) 1.90
well as the Color Index denomination. preparing, treating, packaging, transporting or holding ment (CSA). It broadens the requirements of chemical
Chromium (III) (Cr III) 37.50
food, subject to the following provisions: properties, e.g., migration limits, to 19 chemical elements.
Contrary to this, the Japan Hygienic Olefin Styrene The migration limits for these chemical elements are Chromium (VI) (Cr VI) 0.02
(a) The term colorant means a dye, pigment or other
Plastics Association (JHOSPA) registers products with substance that is used to impart color to, or to alter considerably lower than under the old TSD. In addition, Cobalt (Co) 10.50
their trade names only. Chemically identical products the color of, a food contact material, but that does certain fragrances, CMR substances and nitrosamines
Copper (Cu) 622.50
with different names are thus not accepted. not migrate to food in amounts that will contribute to are restricted. Toys for children under 3 years and toys
that food any color apparent to the naked eye. The for mouth contact have to fulfill Article 3 of the Frame- Lead (Pb) 13.50
term ‘‘colorant’’ includes substances such as optical work Regulation (EC) No. 1935/2004. Annex II, Part Manganese (Mn) 1,200.00
Mercosul/Mercosur brighteners and fluorescent whiteners, which may III of the new TSD and its amendment (Commission
Mercury (Hg) 7.50
not themselves be colored, but whose use is intend Directive 2012/7/EU) for Category I.
In the South American region colorants for plastic food ed to affect the color of a food contact material. Nickel (Ni) 75.00
contact materials have to meet the requirements of the (b) The colorant must be used in accordance with Migration limits for toys or components of toys Org. Tin (org. Sn) 0.90
Mercosul/Mercosur GMC Resolución N° 15/2010, im- current good manufacturing practice, including use (dry, brittle, powder-like or pliable toy materials)
Selenium (Se) 37.50
plemented, e.g., in Brazil (Resolução RDC N° 52/2010). levels that are not in excess of those reasonably
These are purity limits similar to the Council of Europe required to accomplish the intended coloring effect. With the entry into force of the new TSD, the Norm Strontium (Sr) 4,500.00
Resolution AP (89) 1. However, more elements and partly EN 71-3 has also been revised taking into account the
(c) Colorants listed in 21 CFR 178.3297 must conform Tin (Sn) 15,000.00
different analytical methods have to be considered. additional chemical elements.
to the description and specifications as indicated. If Zinc (Zn) 3,750.00
a polymer described in this section is itself the sub-
In case more information is required, please contact ject of a regulation promulgated under Section 409 The EN 71-3:2013 specifies the requirements and test
Table 3: Migration limit of EN 71-3:2013
pigments-safety@basf.com. of the Federal Food, Drug and Cosmetic Act, it shall methods for migration of the above-mentioned chemical
also comply with any specifications and limitations elements from toys and toy components.
prescribed by that regulation.
USA
(d) Color additives and their lakes listed for direct use
Australia, AS/NZS ISO 8124-3:2010 USA, ASTM F 963-11
in foods, under the provisions of the color additive
Food contact substances (FCS) are regulated by the
regulations in parts 73, 74, 81 and 82 of this chap-
Food and Drug Administration (FDA) for use in food ISO 8124-3:2010 specifies some maximum accept All toys in the United States must meet the ASTM
ter, may also be used as colorants for food contact
contact applications (the colored polymer is in direct able levels, methods of sampling and extraction prior F 963-11 safety requirements, Standard Consumer
polymers.
contact with the food). These substances were either to analysis for the migration of the elements antimony, Safety Specification for Toy Safety. The limits and test
regulated in the Code of Federal Regulations (CFR), For more detailed explanation please refer to Appendix: arsenic, barium, cadmium, chromium, lead, mercury method of soluble elements are equivalent to the old
Title 21, Parts 170–199 or as amended, or are listed Definitions and Abbreviations. and selenium from toy materials and parts of toys. EN 71-3:2002 as listed in Appendix: Definitions and
on the FDA’s Inventory of Effective Premarket Notifi- Abbreviations, except that ASTM F963-11 requires
cations website listing the food contact notifications The maximum acceptable element migration from the additional total lead test and the 24-hour special
(FCN) http://www.fda.gov/Food/IngredientsPackag toy materials is equivalent to the old EN 71-3:2002 cadmium extraction test for metallic small parts.
ingLabeling/PackagingFCS/Notifications/default.htm. requirements as listed in Appendix: Definitions and
Abbreviations.
46 Other sensitive applications
Disclaimer
Other sensitive applications Disclaimer
Apart from food contact packaging and toys applications, additional applications can Appropriate processing conditions for the articles have to be applied. The suitability of
be considered based on the risk dimensions of their intended use. The following briefly the articles for the application concerned, including their effect on the smell and taste
covers the requirements for some of those applications, detailed by national regulations of the food, and observance of any given limitations (for example, overall migration,
when applicable. specific limits and other analytical requirements) must be tested and ensured in each
case by the person who introduces the articles into circulation. Since our products are
manufactured on an industrial scale, the presence of traces of impurities cannot be
ruled out. Kindly also take note of the fact that analysis of our product for compliance
Medical devices Pharmaceutical packaging
with the above-mentioned legislation is not routinely carried out for each lot. It is
A medical device is an instrument, apparatus, implant, Pharmaceutical packaging is a part of the pharmaceu- performed randomly and on the basis of standardized tests. Therefore, regulatory
in vitro reagent, or similar or related article that is used tical drug registration. The regulation of pharmaceutical
to diagnose, prevent or treat disease or other conditions. drugs varies from jurisdiction to jurisdiction. The require
compliance is not part of our quality control nor part of the product specification or the
Medical devices act by mainly physical, mechanical or ments depend on the risk class of the end application. certificate of analysis.
thermal means. Food contact compliance is obligatory for plastic color
ants used in pharmaceutical packaging.
The medical device application is a highly regulated
end application. The requirements depend on the risk
class of the end application. The approval of the end Drinking water applications Organoleptic properties of colored plastic This can impact the range of secondary constituents
application requires a considerable amount of data on food contact materials and articles and thus, for example, result in changes to the original
plastic raw materials, plastic converting steps and sa- Drinking water approvals are applicable to materials and plastic material and article composition. Moreover,
fety assessment of the end article. There is no specific end articles in contact with drinking water. The regulatory According to the Framework Regulation 1935/2004 migration of secondary constituents from the plastic
regulation for all plastic raw materials. Food contact requirements are country-specific. The responsibility rests Art. 3, food contact materials and articles must inter article can deteriorate organoleptic properties of the
compliance is obligatory for plastic colorants used in with the end-article producer. In Europe, the approval alia not change organoleptic properties like odor or food. Their migration ability into food is influenced by
medical devices. procedures for use with drinking water are regulated by taste of food. In this respect colored plastic materials the conditions of use i.e. type of polymer, temperature
the individual countries. The approvals are granted by and articles have to meet this requirement. range, concentration level in the matrix and food type
In the EU, all medical devices must be identified with institutes that are authorized to carry out tests and issue such as fatty, alcoholic, water based.
the CE mark. certificates on the basis of the corresponding require- Usually, several processing steps are carried out on the
ments. The relevant approval regulations includethe Re- way from the starting materials like polymers, additives, Due to the above-described factors which are largely
commendations Pertaining to Plastics and Drinking Water colorants to the final plastic food contact material and outside of the sphere of influence of colorant manufac-
Cosmetic packaging applications (KTW) as well as the standards of the German Technical article. turers, the suitability of the articles for the food contact
and Scientific Association for Gas and Water(DVGW), application, including their effect on odor and taste of
The EU Cosmetic Regulation (EC) No. 1223/2009 the Water Regulations Advisory Scheme (WRAS) in Great These steps include various processes in plastics pro- the food, must be tested and ensured in each case by
(Annex I, Part A) introduced the requirement to report Britain, the Certificate of Sanitation Conformity (ACS) in duction, in most cases connected with shear influences the person who introduces the articles into circulation.
on packaging materials, impurities and traces within France, and for China, approvals are obtained from the and thermal stress. The colorants are incorporated in a
the product safety information. The product safety Chinese MOH (Ministry of Health). plastic material matrix together with further auxiliaries.
information includes the relevant characteristics of the
packaging material, in particular the purity and stability In USA, NSF International (National Science Foundation),
of the final packaging and its components. Statements an independent US government agency, carries out
are required if prohibited substances are present in drinking water approvals in accordance with Standard 61
trace amounts and evidence that it is technically un (NSF61). The NSF tests and certifies all products within
avoidable. the entire drinking water system.
48 Appendix: Definitions and abbreviations
Appendix: Definitions and abbreviations
Appendix:
Definitions and abbreviations
Pigments EU food contact materials NIAS (non-intentionally added Common types of Food contact substances include
substances) coatings, plastics, paper, adhesives, as well as colorants,
According to DIN 55943: 2001-10 is a pigment “particu As defined in the EU Framework Regulation (EC) No. antimicrobials and antioxidants found in packaging.
late substance that is practically insoluble in the medium 1935/2004. Materials and articles, which in their fin As defined in the Regulation (EU) No. 10/2011 on plas-
in which it is incorporated, used as a colorant or due to ished state tic materials and articles intended to come into contact Hierarchy from food contact substance (FCS) through
its anti-corrosion and magnetic properties.” §§ Are intended to be brought into contact with food with food. food contact material (FCM) to food contact article
(FCA):
§§ Are already in contact with food and were intended
“NIAS” stands for non-intentionally added substance The food contact substance (FCS) is a single substance,
for that purpose
Dyes and is an impurity in the substances used or a reaction such as a polymer, an antioxidant or colorant in a poly-
§§ Can reasonably be expected to be brought into con- intermediate formed during the production process or mer. As a substance, it is reasonably pure (the chemist’s
“Dyes” is a collective term for colorants soluble in tact with food or to transfer their constituents to food a decomposition or reaction product. definition of substance). Even though a polymer may
solvents and/or binders. under normal or foreseeable conditions of use be composed of several monomers, it still has a well-
defined composition. Food contact notifications (FCN)
Examples of NIAS in products are: are required only for new uses of FCSs that are food
Colorants (ETAD definition) Examples additives. Although a notification is not required for a food
Impurities contact substance that is GRAS or prior sanctioned for
A colorant is a product intended to impart or modify the §§ Food packaging and containers, kitchen equipment, §§ Present in the raw materials or solvents its intended use in contact with food, some companies
color of a substrate. In order to do it, the colorant will cutlery and dishes do choose to notify the agency in order to clarify the
Reaction products
possess the ability to change the color of reflected or §§ Processing equipment, such as coffee makers or regulatory status of such substances.
transmitted light as the result of wavelength-selective production machinery §§ Formed during the synthesis of the additive
absorption. §§ Containers used in transport of food or pigment Unlike food additive regulations and threshold of regu
§§ Formed during the manufacturing and use lation exemptions (TOR), approvals under the FCN
In addition, a colorant may also contain deliberately EU legislation for food contact materials covers materials of plastic materials and articles process are proprietary. This is because Section 409(h)
added components, which in contact with water intended for human consumption, §§ Formed during the storage and manufacturing (1)(C) of the FD&C Act states that an FCN is effective
§§ Maintain the properties of the colorant during e.g., bottles, with the exception of fixed public or private of polymers only for the manufacturer and substance identified in the
production and use water supply equipment. notification. Thus, any person wishing to rely on an FCN
Degradation products needs to demonstrate that the FCS being marketed
§§ Influence specific properties of the colorant
has been manufactured or supplied by the manufactur
as fitting to its application
er identified in the FCN and is being used under the
These added components should be termed FCS (food contact substances) conditions that are the subject of the FCN. Food contact
as colorant additives. material (FCM) is made with the FCS and (usually) other
As defined by the U.S. Food and Drug Administration substances. It is often (but not necessarily) a mixture,
Furthermore, depending on the production process, (FDA) in Section 409 of the Federal Food, Drug and such as an antioxidant in a polymer. The composition
a colorant may also contain certain non-intentionally Cosmetic Act (FD&C Act). may be variable. The food contact article is the finished
added substances (NIAS), e.g., residues of starting film, bottle, tray or whatever that is formed out of the
materials, byproducts, etc. These NIAS are not intended Any substance intended for use as a component of FCM.
to have a technical effect in the substrate to which the materials used in manufacturing, packing, packaging,
colorant is applied. transporting or holding food if such use is not intended
to have a technical effect in such food (formerly known
as indirect food additives).
50 Appendix: Definitions and abbreviations
Appendix: Definitions and abbreviations
GRAS (generally recognized as safe) Parts 182, 184 and 186 of the Food Additive Regula The exclusion of substances that are GRAS from FCN (food contact notification)
tions list many substances that are recognized or the definition of the term “food additive” means that
“GRAS” is an acronym for the phrase generally recog- affirmed as GRAS by FDA. Section 182.1 of the Food such substances do not require pre-clearance by the The FCN process has been introduced with the Food
nized as safe. Additive Regulations makes it clear that those listed FDA under Section 409 of the act. If a manufacturer and Drug Administration Modernization Act of 1997
are by way of illustration and do not represent an determines that a particular substance is GRAS, it is (FDAMA). The FCNs are proprietary to the manufactur
As defined by the U.S. Food and Drug Administration all-inclusive list. The absence of a substance from the free to market the substance without notification to, er for which the notification is effective.
(FDA) in Sections 201(s) and 409 of the Federal Food, list does not preclude an independent determination or approval by, the FDA. Obviously, if the FDA should
Drug and Cosmetic Act (FD&C Act). that the substance is GRAS when used in a particular consider the manufacturer’s determination of GRAS
application. For example, any substance generally status to be erroneous, the agency can take appropri- EU toy Norm EN 71-3:2002
Any substance that is intentionally added to food is a recognized as safe in or on food is also permitted to be ate regulatory action; in this case the burden of proof
food additive and subject to pre-market review and used under conditions of good manufacturing practice would fall upon the FDA to demonstrate that the sub- European standard EN 71, Part 3 (migration of sub
approval by the FDA, unless the substance is generally as a component of articles that contact food. 21 CFR stance is not GRAS. This is an unlikely consequence stances from toy materials), lays down limits for heavy
recognized, among qualified experts, as having been §174.5(d)(1). unless a real public health problem presents itself. metals that are soluble in 0.07 N hydrochloric acid.
adequately shown to be safe under the conditions of The EN 71-3:2002 has been revised in 2013 but is
its intended use, or unless the use of the substance The FDA has codified requirements for the classification still used as reference for other toy regulations in other
is otherwise excluded from the definition of a food of substances as GRAS under 21 C.F.R. § 170.30(a). TOR (threshold of regulation) countries.
additive.
As stated therein, general recognition of safety must be The threshold of regulation (TOR) lists exemptions
For example, substances whose use meets the defini based on: that have been issued under 21 CFR i.e. 170.39 the Limits of element migration from
Element
tion of a pesticide, a dietary ingredient of a dietary threshold of regulation for substances used in food toy materials [ppm]
Scientific procedures, or
(1)
supplement, a color additive, a new animal drug, or contact articles. A substance used in a food contact Antimony (Sb) 60
In the case of a substance used in food prior to
(2)
a substance approved for such use prior to Septem- article may be exempted by the FDA from the need Arsenic (As) 25
January 1, 1958, through experience based on
ber 6, 1958, are excluded from the definition of food of an FCN or a petition (regulation) as a food additive
common use in food. Barium (Ba) 1,000
additive. if the use in question has been shown to result in a very
General recognition of safety requires a “common low concentration (0.5 ppb). Threshold of regulation Cadmium (Cd) 75
Sections 201(s) and 409 were enacted in 1958 as part knowledge” about the substance throughout the exemptions are generally applicable and are effective
Chromium (Cr III) 60
of the Food Additives Amendment to the FD&C Act. scientific community knowledgeable about the safety for the food contact substance (FCS) for the listed
While it is impracticable to list all ingredients whose of substances directly or indirectly added to food. For intended use regardless of manufacturer or supplier. Lead (Pb) 90
use is generally recognized as safe, FDA published a substances not widely used in food prior to 1958, Mercury (Hg) 60
partial list of food ingredients whose use is generally general recognition of safety based on “scientific
Selenium (Se) 500
recognized as safe to aid the industry’s understanding procedures” requires the same quantity and quality of Prior sanctioned substances
of what did not require approval. scientific evidence as is required to obtain approval of a
Table 4: Migration limit of EN 71-3:2002
food additive regulation for the ingredient. Unlike a food Prior sanctioned substances under 21 CFR 181 are
Section 174.5(d)(1) of the Food Additive Regulations additive petition, however, general recognition of safety those substances whose use in contact with food
states that substances generally recognized as safe is ordinarily based on published studies, which may be is the subject of a letter issued by the FDA or USDA
“among experts qualified by scientific training and corroborated by unpublished studies and other data before 1958 offering no objection to a specific use of a
experience to evaluate their safety,” under conditions and information. specific substance.
of good manufacturing practices, are permitted to be
used as components of articles that contact food.
Contacts
Asia Pacific Americas
BASF Colors & Effects Shanghai Ltd. BASF Colors & Effects USA LLC
No 300, Jiang Xin Sha Road 24710 West Eleven Mile Road
200137 Shanghai Southfield, MI 48034
China USA
Europe
BASF Colors & Effects GmbH

An der Rheinschanze 1
67059 Ludwigshafen
Germany
pigments-safety@basf.com
Visit our website: www.colors-effects.basf.com

The descriptions, designs, data and information contained herein are presented in good faith, and are based on BASF’s current knowledge and experience. They are provided for guidance
only, and do not constitute the agreed contractual quality of the product or a part of BASF’s terms and conditions of sale. Because many factors may affect processing or application/use of
the product, BASF recommends that the readers carry out their own investigations and tests to determine the suitability of a product for its particular purpose prior to use. It is the responsibility
of the recipient of product to ensure that any proprietary rights and existing laws and legislation are observed. No warranties of any kind, either expressed or implied, including, but not limited
to, warranties of merchantability or fitness for a particular purpose, are made regarding products described or designs, data or information set forth herein, or that the products, descriptions,
designs, data or information may be used without infringing the intellectual property rights of others. Any descriptions, designs, data and information given in this publication may change without
prior information. The descriptions, designs, data and information furnished by BASF hereunder are given gratis and BASF assumes no obligation or liability for the descriptions, designs, data or
information given or results obtained; all such being given and accepted at the reader’s risk.
® = Registered trademark of BASF SE
September 2017
G-EDP 0917e

Guia de Colorantes

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Guia de Colorantes

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Colorants portfolio for

Introduction 4 Legislation on toys 45

Colorants portfolio for Other sensitive applications 46

Legislation for food

Colorants portfolio for

Status as of September 2017

This portfolio is regularly reviewed according to business needs and regulatory

Food Contact Regulations

Cinquasia® Magenta K 4535 Cinquasia® Magenta RT-235-D PR 202 1 1 1 5 5 1 1 5 5 1 1 5 1 1

Cinquasia® Magenta K 4535 FP Cromophtal® Magenta P PR 202 1 1 1 5 5 1 1 5 5 1 1 5 1 1

Cinquasia® Pink K 4410 Cromophtal® Pink 2000 PR 122 1 1 1 5 1 1 1 5 5 1 1 5 1 -

Cinquasia Pink K 4430 FP

Cinquasia Red K 4104

Cinquasia Red K 4111

Cinquasia® Red K 4330 Cinquasia® Red B RT-195-D - 1 1 1 5 0 1 1 5 5 0 1 5 1 1

Cinquasia® Violet K 5350 Cinquasia® Violet R RT-891-D PV 19 1 5 1 5 0 5 5 5 5 0 1 5 1 1

Cinquasia Violet K 5350 FP

Cromophtal Brown K 3001

Cromophtal Orange K 2960

Cromophtal® Red K 3830 Cromophtal® Red G PR 220 1 1 1 5 5 1 1 5 5 5 1 5 1 1

Cromophtal® Red K 3890 Cromophtal® Red BRN PR 144 1 1 1 5 5 1 1 0 5 5 1 5 1 1

Cromophtal Red K 3890 FP

Cromophtal Red K 3900

Cromophtal Red K 3900 FP

Cromophtal® Red K 4035 Cromophtal® Red 2B PR 221 1 1 1 5 1 1 1 0 5 5 1 5 1 -

Cromophtal® Scarlet K 3540 Cromophtal® Scarlet RN PR 166 1 1 1 5 5 1 1 0 5 5 1 5 1 1

Cromophtal Violet K 5700

Cromophtal Yellow 2GF

Cromophtal Yellow K 0990

Cromophtal® Yellow K 0990 FP Cromophtal® Yellow 8GNP PY 128 1 1 1 5 1 1 1 0 5 5 1 5 1 -

Cromophtal® Yellow K 1210 Cromophtal® Yellow 3G PY 93 1 1 1 5 5 1 1 5 5 5 1 5 1 1

Cromophtal Yellow K 1210 FP

Cromophtal Yellow K 1310

Cromophtal Yellow K 1410

Cromophtal® Yellow K 1500 Cromophtal® Yellow GR PY 95 1 1 1 5 1 1 1 5 5 5 1 5 1 1

Cromophtal® Yellow K 1500 FP Cromophtal® Yellow GRP PY 95 1 1 1 5 1 1 1 5 5 5 1 5 1 1

Eupolen PE Blue 69-1501

Eupolen PE Blue 69-2001

Eupolen PE Blue 69-2004

* For more information please contact pigments-safety@basf.com

Food Contact Regulations

Eupolen® PE Blue 69-2005 - PB 15:1 1 5 1 1 5 5 5 5 0 1 1 5 1 1

Eupolen® PE Blue 70-9001 - PB 15:3 1 5 1 1 5 5 5 5 0 1 1 5 1 1

Eupolen® PE Blue 70-9004 - PB 15:3 1 5 1 1 5 5 5 5 0 1 1 5 1 1

Eupolen PE Blue 70-9005

Eupolen PE Blue 71-0401

Eupolen PE Brown 29-1505

Eupolen® PE Green 87-3001 - PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5

Eupolen® PE Green 87-3004 - PG 7 5 5 1 5 5 5 5 5 0 5 5 5 1 5

Eupolen PE Green 87-3005

Eupolen PE Green 87-3501

Eupolen PE Green 93-6001

Eupolen® PE Red 39-1101 - PR 178 5 1 1 5 1 1 1 5 0 0 1 5 1 1

Eupolen® PE Red 47-9001 - PR 122 1 1 1 5 1 1 1 5 0 1 1 5 1 1

Eupolen PE Yellow 09-6101

Eupolen PE Yellow 11-5501

Eupolen PE Yellow 13-1501

Eupolen® PE Yellow 17-6001 - PY 191:1 1 5 1 5 5 5 5 5 0 0 1 5 1 1

Eupolen® PE Yellow 17-6004 - PY 191:1 1 5 1 5 5 5 5 5 0 0 1 5 1 1

Eupolen PE Yellow 18-0001

Eupolen PE Yellow 18-4101

Eupolen PE Yellow 18-4104

Eupolen® PE Yellow 18-4105 - PY 139 5 1 1 1 0 1 1 0 0 0 1 0 - 1